2013 BEST-IN-SHOW WINNER: GORE Septal Occluder, manufactured and submitted by W. L. Gore & Associates Inc. (Flagstaff, AZ). Each year the MDEA Jurors vote from among the Gold Winning products to select the Best-In-Show Winner. The GORE Septal Occluder is a permanent implant delivered via a transcatheter approach. It is used to treat congenital heart defects of the atrial septum: Atrial Septal Defect and Patent Foramen Ovale. It prevents shunting of the blood between the right and left atria.
Critical-Care and Emergency Medicine Products
1. GOLD WINNER: AccuVein AV400 vein illumination system, manufactured and submitted by AccuVein Inc. (Cold Spring Harbor, NY). The AccuVein AV400 displays a map directly on the skin’s surface to locate veins for procedures including IV starts, blood draw, sclerotherapy, and general and cosmetic surgery. Locating peripheral vasculature can be invaluable in many medical procedures. Supply and design credit to Zietlow Design (Piedmont, CA), and Aequorix Scientific (Scarborough, ON, Canada).
2. SILVER WINNER: Companion 2 Driver System in-hospital pneumatic power supply for the SynCardia temporary Total Artificial Heart, manufactured and submitted by SynCardia Systems Inc. (Tucson, AZ). The Companion 2 Driver System powers the SynCardia temporary Total Artificial Heart inside the hospital. The Driver is docked in the Hospital Cart for surgery and initial recovery, and in the Driver Caddy once the patient’s condition begins to stabilize. Supply and design credit to DC Electronics (San Jose, CA), Lynium LLC (Tucson, AZ), and Bimba Manufacturing (University Park, IL).
3. BRONZE WINNER: Rota-Trach disposable standard tracheostomy tube, manufactured and submitted by Vitaltec Corp. (Taichung City, Taiwan). Rota-Trach tracheostomy tube is for patients with respiratory failure or who are at risk of aspiration or secretion retention and require tracheal access for airway management. A tube inserted into the trachea provides air to the patient.
4. FINALIST: Infrascanner Model 2000 handheld brain hematoma screening device, manufactured by InfraScan Inc. (Philadelphia, PA). Entry submitted by Inteprod LLC (Eagleville, PA). Infrascanner is a noninvasive, portable, handheld device designed to assist first responders and clinicians in identifying life threatening brain hematomas. It enables expedient assessment of patients and potentially facilitates life-saving treatment. Supply and design credit to Inteprod LLC (Eagleville, PA), and John Ferguson Design (Southampton, PA).
Dental Instruments, Equipment, and Supplies
1. GOLD WINNER: EPIC Total Diode Solution, manufactured and submitted by BIOLASE Inc. (Irvine, CA). EPIC is a semiconductor diode laser system that facilitates three different types of dental treatment, including soft tissue surgical procedures, laser-assisted tooth whitening, and temporary relief of minor pain in the oral/maxillofacial region. Supply and design credit to Morphix Design (San Clemente, CA).
2. SILVER WINNER: Zimmer Trabecular Metal Dental Implant, manufactured and submitted by Zimmer Dental Inc. (Carlsbad, CA). The Trabecular Metal Dental Implant features an 80% porous, osteoconductive midsection that is structurally similar to bone. It facilitates bone ingrowth and ongrowth, and can replace one or more missing teeth in a variety of clinical conditions.
3. BRONZE WINNER: Carestream CS 8100 Digital Panoramic System, manufactured by Carestream Dental (Croissy-Beaubourg, Marne La Vallee, France). Entry submitted by Carestream Dental (Atlanta, GA). The CS 8100 makes positioning easier, image acquisition faster, and higher image quality more accessible, by blending advanced, sophisticated technology in an extremely simple and compact system.
4. FINALIST: 3M ESPE Intra-Oral Syringe, manufactured and submitted by 3M Deutschland GmbH, 3M ESPE Division (Seefeld, Germany). The Intra-Oral Syringe is a single-use delivery and mixing device for the precise placement of wash impression materials. It’s ergonomic and hygienic. Less impression material is wasted because it can be prefilled 12 hours prior to application. Supply and design credit to Hack Formenbau (Kirchheim Teck, Baden Wurttemberg, Germany).
General Hospital Devices and Therapeutic Products
1. GOLD WINNER: Dansac NovaLife 1 & 2 Ostomy Pouches, manufactured and submitted by Dansac A/S (Fredensborg, Denmark). Dansac NovaLife 1 & 2 is a series of open and closed ostomy pouches in a 1 and 2 piece version. The purpose of the Dansac NovaLife ostomy pouch is to collect the faeces let out through an ostomy opening in the abdomen. Supply and design credit to Moller Jensen Innovation Design (Copenhagen, Denmark).
2. SILVER WINNER: Optiflow Junior Nasal Cannula, manufactured and submitted by Fisher & Paykel Healthcare (Manukau, Auckland, New Zealand). The Fisher & Paykel Healthcare’s Optiflow Junior is a next-generation nasal cannula which can deliver heated, humidified blended gas to patients in respiratory distress, ranging in sizes to fit premature babies to pediatric children.
3. BRONZE WINNER: PowerGlide Midline Catheter, manufactured and submitted by Bard Access Systems (Salt Lake City, UT). The PowerGlide Midline Catheter offers an all-in-one insertion mechanism with an integrated guidewire to assist with difficult IV sticks while the 8-10 cm body-softening catheter allows for dwell times up to 29 days, and can be used for power injection.
4. FINALIST: LUSTRE Pure Light Treatment for Acne, manufactured by Ambicare Health (Edinburgh, Scotland, United Kingdom). Entry submitted by Kinneir Dufort (Bristol, United Kingdom). LUSTRE Pure Light is a light technology to treat spots. It was developed by leading dermatologists and tested by healthcare professionals. It is the world’s first wearable device for the treatment of mild to moderate acne. Supply and design credit to Kinneir Dufort (Bristol, United Kingdom), and Solid Semecs (Uden, Netherlands).
4. FINALIST: Stryker Prime TC Transport Chair, manufactured and submitted by Stryker Medical (Portage, MI). The Prime TC transport chair is a safe, simple, and reliable seated transport device designed for the acute care environment. It improves the experience for the patient, care giver, and hospital. Supply and design credit to Michael Graves Design Group (Princeton, NJ).
4. FINALIST: ViSi Mobile comprehensive body-worn vital signs monitoring system, manufactured by Sotera Wireless Inc. (San Diego, CA). Entry submitted by Eastman Chemical Co. (Kingsport, TN). The ViSi Mobile System is a continuous, body-worn vital signs monitor that detects a patient’s condition and allows early intervention to prevent adverse events. The lens, housing and connectors are made with Eastman Tritan copolyester. Supply and design credit to Eastman Chemical Co. (Kingsport, TN), DDSTUDIO (Carlsbad, CA), Affinity Medical Technologies LLC (Costa Mesa, CA), and Phillips Plastics Corp. (San Diego, CA).
Implant and Tissue-Replacement Products
1. GOLD WINNER: GORE Septal Occluder, manufactured and submitted by W. L. Gore & Associates Inc. (Flagstaff, AZ). The GORE Septal Occluder is a permanent implant delivered via a transcatheter approach. It is used to treat congenital heart defects of the atrial septum: Atrial Septal Defect and Patent Foramen Ovale. It prevents shunting of the blood between the right and left atria.
2. SILVER WINNER: Cochlear Nucleus CR120 Intraoperative Remote Assistant, manufactured and submitted by Cochlear Ltd. (Macquarie University, NSW, Australia). The Cochlear Nucleus CR120 Intraoperative Remote Assistant is a wireless and intuitive to use hand-held device that performs fast diagnostics on the cochlear implant. It also measures neural responses to create a hearing profile for immediate hearing. Supply and design credit to In-Tech Electronics (Shenzhen, Guangdong, China), and Silicon and Software Systems Ltd. (Wroclaw, Poland).
3. BRONZE WINNER: Orthofix Ankle Compression Nailing System (ACN), manufactured by Orthofix Srl. (Bussolengo, Italy). Entry submitted by Orthofix Inc. (Lewisville, TX). The Ankle Compression Nailing System is an ankle fusion nail device consisting of an implant, screws, and locking caps. The implant is inserted through the base of the calcaneus into the medullary canal of the tibia via a radio-translucent dual targeting arm. Supply and design credit to AIP Precision Machining (Daytona Beach, FL), Orchid Arcadia (Arcadia, CA), and Orchid Design (Shelton, CT).
4. FINALIST: ATI Neurostimulation System, an implantable neurostimulator device that targets the sphenopalatine ganglion (SPG) for the treatment of severe headache, manufactured and submitted by Autonomic Technologies Inc. (Redwood City, CA). The ATI Neurostimulation System is a small, minimally invasive, rechargeable implant designed for the facial anatomy. It is activated by a patient-controlled remote controller to deliver as-needed stimulation to relieve a headache attack.
4. FINALIST: DynaNail Ankle Arthrodesis Nail, manufactured and submitted by Medshape Inc. (Atlanta, GA). DynaNail is intended for tibiotalocalcaneal arthrodesis procedures. With its internal pseudoelastic nitinol element, DynaNail provides the sustained compression of an external fixator, while having the low profile and rigidity of an intramedullary nail.
4. FINALIST: Nucleus CI422 cochlear implant with Slim Straight Electrode, manufactured and submitted by Cochlear Ltd. (Macquarie University, NSW, Australia). The Nucleus CI422 cochlear implant (CI422 implant) features the Slim Straight Electrode, which enables surgical placement in the cochlea with minimal trauma. This technology supports preservation of the existing, delicate structures in the cochlea.
In Vitro Diagnostic Products and Systems
2. SILVER WINNER: EDGE Platform, manufactured and submitted by HTG Molecular Diagnostics Inc. (Tucson, AZ). The HTG EDGE Platform is a research and clinical tool that fully automates the RNA expression analysis process in less than 24 hours. The proprietary HTG qNPA technology enables mRNA quantitation without time-consuming extraction, amplification, or synthesis.
3. BRONZE WINNER: Irys genomics platform, manufactured by BioNano Genomics (San Diego, CA). Entry Submitted by Sparton Medical (Strongsville, OH). Irys is an automated high-resolution single-molecule imager to analyze linearized single DNA molecules in IrysChip nanochannel arrays. The system allows the study of unique aspects of genomes that cannot currently be detected by other methods. Supply and design credit to Sparton Medical (Strongsville, OH), and HS Design Inc. (Gladstone, NJ).
4. FINALIST: Vantera Clinical Analyzer, manufactured and submitted by LipoScience Inc. (Raleigh, NC). The Vantera Clinical Analyzer automatically measures clinical serum samples via NMR to create digitized spectral data and report multiple analyte concentrations from a single sample. It includes a NMR spectrometer, automated fluidics, and software. Supply and design credit to KMC Systems Inc. (Merrimack, NH), and Agilent Technologies Inc. (Santa Clara, CA).
MDDIonline.com Readers Choice Award
2013 READERS CHOICE WINNER: t:slim Insulin Pump, The t:slim was selected by popular vote on MDDIonline.com’s first ever MDEA Readers’ Choice poll. The entire community of MD+DI readers weighed in on their choice for the top MDEA finalist product. More than 4,200 readers voted...and the 2013 winner was t:slim, manufactured and submitted by Tandem Diabetes Care Inc. (San Diego, CA). The t:slim is the first touchscreen insulin pump for people with diabetes. Its smartphone-style interface is simple to teach, learn, and use. The slimmest pump available, t:slim holds 300 units of insulin and uses a rechargeable battery.
Medical Product Packaging, Graphic Instructions, and Labeling Systems
1. GOLD WINNER: Lantus & You Journal for Lantus SoloSTAR (insulin glargine [rDNA origin] injection pen), manufactured by Sanofi (Bridgewater, NJ). Entry submitted by IDEO (Boston, MA). The Lantus & You Journal supports patients with type 2 diabetes who are new to using the Lantus SoloSTAR insulin injection pen by offering them an easy, step-by-step guide and a calming experience during their first 7 days of treatment. Supply and design credit to IDEO (Boston, MA), and HAVAS Life NY (New York, NY).
Over-The-Counter and Self-Care Products
1. GOLD WINNER: new Glucose Sensor Serter, manufactured and submitted by Medtronic Minimed (Northridge, CA). The new glucose sensor insertion device (not approved in the USA) is used by people with diabetes who use the Paradigm Veo insulin pump with built-in continuous glucose monitoring. It is used to insert the glucose sensor beneath the skin. Supply and design credit to Bridge Design (San Francisco, CA).
2. SILVER WINNER: SpeediCath Compact Set ready-to-use coated catheter in sterile solution with attached bag, manufactured and submitted by Coloplast A/S (Humlebaek, Denmark). The SpeediCath Compact Set is intended for urine bladder drainage through the urethra. The catheter is attached to a urine bag for collection of urine. The product is a single-use sterile device. Supply and design credit to Native Design Ltd. (London, United Kingdom).
3. BRONZE WINNER: Masimo iSpO2 Pulse Oximeter and the iSpO2 App available in the AppleApp Store, manufactured and submitted by Masimo Corp. (Irvine, CA). Masimo’s iSpO2 is a measure-through-motion and low-perfusion pulse oximeter made for the iPhone and iPad. It allows noninvasive tracking of blood oxygen, pulse, and perfusion index. The system creates a graphic of measurement over time that can be e-mailed.
4. FINALIST: AllStar Reusable Insulin Delivery Device, manufactured by Sanofi India Ltd. (Mumbai, India). Entry submitted by DCA Design International (Warwickshire, United Kingdom). AllStar is a reusable insulin pen, produced by a global company in India. Developed especially for patients in emerging markets, AllStar conforms to ISO standards and is equipped with state-of-the-art features. Supply and design credit to DCA Design International (Warwick, Warwickshire, United Kingdom), Sanofi Aventis Deutschland GmbH (Frankfurt am Main, Germany), Shaily Ltd. (Gujarat, India), Unitech Technology Yeh Corp. (South Dist, Tainan City, Taiwan ROC), Clamason Industries Ltd. (West Midlands, United Kingdom), Smalley Steel Ring Co. (Lake Zurich, IL), Promedix GmbH (Darmstadt, Germany), Chapel Technical Projects Ltd. (Cheshire, United Kingdom), and Linki Ltd. (Sandbach, United Kingdom).
4. FINALIST: FreeStyle InsuLinx Blood Glucose Monitoring System, manufactured by Abbott Diabetes Care (Alameda, CA). Entry submitted by Bridge Design (San Francisco, CA). The FreeStyle InsuLinx Blood Glucose Monitoring System is a touchscreen meter that helps calculate the correct insulin doses and makes insulin-dosing suggestions. A clinician programs the system for each patient. Supply and design credit to Bridge Design (San Francisco, CA).
4. FINALIST: NovoPen 5 insulin pen with memory function, manufactured by Novo Nordisk A/S (Copenhagen, Denmark). Entry submitted by ESP Bioscience (Crowthorne, Berkshire, United Kingdom). NovoPen 5 is a new durable insulin pen with an easy-to-use memory function designed for peace of mind. The memory function meets a key need of people with diabetes, the dilemma of when they took their last dose and how much insulin they injected.
Radiological and Electromechanical Devices
1. GOLD WINNER: Acessa minimally invasive, outpatient therapy for treating uterine fibroids, manufactured and submitted by Halt Medical Inc. (Brentwood, CA). Acessa is a minimally invasive, outpatient therapy for treating fibroids using radiofrequency volumetric thermal ablation. Each fibroid is destroyed by applying energy through a small needle array. The normal function of the uterus is preserved. Supply and design credit to CullDez Product Development (Livermore, CA), Aim Design (Brentwood, CA), Dean Miller Associates (Menlo Park, CA), Bruxton Corp. (Seattle, WA), and Know-How Consulting (Honolulu, HI).
2. SILVER WINNER: Liposonix Custom Contouring, manufactured by Solta Medical (Hayward, CA). Entry submitted by General Assembly (Seattle, WA). Liposonix is a proven, unique, and effective aesthetic device built on high-intensity ultrasound technology focused on the removal of stubborn fat cells. Liposonix is used by doctors to provide a safe, noninvasive, nonsurgical alternative to liposuction. Supply and design credit to General Assembly (Seattle, WA).
3. BRONZE WINNER: Avedro KXL System for accelerated corneal crosslinking, manufactured and submitted by Avedro (Waltham, MA). The KXL System achieves accelerated-crosslinking by increasing UVA power and reducing procedure time from one hour to a few minutes. It maintains the same energy on the eye as standard cross-linking in a faster, more predictable procedure.
4. FINALIST: UltrOZ Elite wearable ultrasonic therapy system, manufactured by ZetrOZ (Trumbull, CT). Entry submitted by Influence & Co. (Columbia, MO). UltrOZ is a wearable ultrasonic therapy system for the treatment of common musculoskeletal conditions in horses. UltrOZ has been used successfully to treat splints, suspensory ligaments and tendons, muscle strains, stiff joints, arthritis, and fractures.
Rehabilitation and Assistive-Technology Products
1. GOLD WINNER: Rifton TRAM transfer and mobility device, manufactured and submitted by Rifton Equipment (Rifton, NY). The Rifton TRAM, a transfer and mobility device, combines three powerful functions in one compact frame. These functions include seated transfers, sit-to-stand lifts and gait training.
2. SILVER WINNER: mySentry Remote Glucose Monitor, manufactured and submitted by Medtronic Diabetes (Northridge, CA). mySentry is the world’s first remote glucose monitor of an integrated insulin pump with CGM. It is designed to enhance nighttime protection with sensor alerts and alarms that awaken the caregiver of a person with diabetes to convey important information. Supply and design credit to Flextronics Industrial (Shenzhen) Co. Ltd. (Shenzhen, Guangdong, China).
3. BRONZE WINNER: t:slim Insulin Pump, manufactured and submitted by Tandem Diabetes Care Inc. (San Diego, CA). The t:slim Insulin Pump is the first touchscreen insulin pump for people with diabetes. Its smartphone-style interface is simple to teach, learn, and use. The slimmest pump available, t:slim holds 300 units of insulin and uses a rechargeable battery.
4. FINALIST: Ambio Remote Health Monitoring System, manufactured by and submitted by Arrayent Health LLC, dba Ambio Health (Stamford, CT). Ambio is the first consumer-affordable, easy-to-use, home health monitoring system. A central gateway communicates wirelessly to health devices anywhere in the home. The web-based Care Portal keeps all stakeholders engaged for improved health. Supply and design credit to Night Owl Interactive (New York, NY), and HS Design Inc. (Gladstone, NJ).
4. FINALIST: Genesis Touch wireless remote patient monitoring device, manufactured and submitted by Honeywell HomMed (Brookfield, WI). The Genesis Touch is a wireless remote patient monitoring device that enables ongoing or transitional patient health management, including disease management and wellness coaching. Supply and design credit to Samsung Mobile (San Diego, CA).
4. FINALIST: ResMed Pixi Paediatric Mask, manufactured and submitted by ResMed Ltd. (Sydney, Australia). The Pixi paediatric mask is intended for children aged 2-7 for whom continuous positive airway pressure or bilevel therapy has been prescribed. Pixi is a nasal mask designed to provide a stable, effective air seal with minimum headgear tension. Supply and design credit to IDE Group (Sydney, Australia).
Surgical Equipment, Instruments, and Supplies
1. GOLD WINNER: Sonicision Cordless Ultrasonic Dissection System, manufactured and submitted by Covidien (Boulder, CO). Sonicision is a cordless ultrasonic dissection device indicated for soft-tissue incision and hemostasis in a variety of surgical procedures. It is a hand-held, pistol-grip-style, battery-powered surgical ultrasonic device.
2. SILVER WINNER: NeoChord DS1000 Chordae Replacement System, manufactured by NeoChord Inc. (Eden Prairie, MN). Entry submitted by Worrell Design Inc. (Minneapolis, MN). The NeoChord DS1000 is a disposable device intended to replace damaged chordae by delivering artificial chordae tendinae, or neochords, in a beating heart using minimally invasive techniques. Supply and design credit to Worrell Design Inc. (Minneapolis, MN).
3. BRONZE WINNER: FORNISEE Lighted Uterine Manipulator System, manufactured and submitted by LSI SOLUTIONS (Victor, NY). The McCarus-Volker FORNISEE System is the world’s first lighted uterine manipulator product. This technology enhances tissue identification, remote manipulation of the uterus, and surgical ergonomics during laparoscopic hysterectomies.
4. FINALIST: Adherus AutoSpray Dural Sealant, manufactured and submitted by HyperBranch Medical Technology (Durham, NC). Adherus AutoSpray is designed for the controlled application of HyperBranch’s dural sealant. AutoSpray significantly improves the assembly and delivery process, provides smooth application, and does not clog during stop and start operations.
4. FINALIST: Aquamantys3 BSC 9.1S bipolar sealer with cutting, manufactured by Medtronic Advanced Energy LLC (Portsmouth, NH). Entry submitted by Continuum Advanced Systems (West Newton, MA). The Aquamantys3 BSC 9.1S is a hand-activated, single-use electrosurgical instrument using transcollation technology to provide low-temperature hemostatic sealing and an integrated monopolar cutting function. It is intended for orthopedic procedures. Supply and design credit to Continuum Advanced Systems (West Newton, MA).
4. FINALIST: iDrive Ultra Powered Stapling System, manufactured and submitted by Covidien (North Haven, CT). The iDrive Ultra Powered Stapling Device (with Covidien’s Endo GIA stapling reloads) provides precision in surgical stapling, enabling surgeons to position and keep the stapler exactly where they intend, using only one hand and a push button. Supply and design credit to Preferred Tool and Die Inc. / Preferred Precision (Shelton, CT).
2013 BEST-IN-SHOW WINNER: GORE Septal Occluder, manufactured and submitted by W. L. Gore & Associates Inc. (Flagstaff, AZ). Each year the MDEA Jurors vote from among the Gold Winning products to select the Best-In-Show Winner. The GORE Septal Occluder is a permanent implant delivered via a transcatheter approach. It is used to treat congenital heart defects of the atrial septum: Atrial Septal Defect and Patent Foramen Ovale. It prevents shunting of the blood between the right and left atria.
1. GOLD WINNER: AccuVein AV400 vein illumination system, manufactured and submitted by AccuVein Inc. (Cold Spring Harbor, NY). The AccuVein AV400 displays a map directly on the skin’s surface to locate veins for procedures including IV starts, blood draw, sclerotherapy, and general and cosmetic surgery. Locating peripheral vasculature can be invaluable in many medical procedures. Supply and design credit to Zietlow Design (Piedmont, CA), and Aequorix Scientific (Scarborough, ON, Canada).
2. SILVER WINNER: Companion 2 Driver System in-hospital pneumatic power supply for the SynCardia temporary Total Artificial Heart, manufactured and submitted by SynCardia Systems Inc. (Tucson, AZ). The Companion 2 Driver System powers the SynCardia temporary Total Artificial Heart inside the hospital. The Driver is docked in the Hospital Cart for surgery and initial recovery, and in the Driver Caddy once the patient’s condition begins to stabilize. Supply and design credit to DC Electronics (San Jose, CA), Lynium LLC (Tucson, AZ), and Bimba Manufacturing (University Park, IL).
3. BRONZE WINNER: Rota-Trach disposable standard tracheostomy tube, manufactured and submitted by Vitaltec Corp. (Taichung City, Taiwan). Rota-Trach tracheostomy tube is for patients with respiratory failure or who are at risk of aspiration or secretion retention and require tracheal access for airway management. A tube inserted into the trachea provides air to the patient.
4. FINALIST: Infrascanner Model 2000 handheld brain hematoma screening device, manufactured by InfraScan Inc. (Philadelphia, PA). Entry submitted by Inteprod LLC (Eagleville, PA). Infrascanner is a noninvasive, portable, handheld device designed to assist first responders and clinicians in identifying life threatening brain hematomas. It enables expedient assessment of patients and potentially facilitates life-saving treatment. Supply and design credit to Inteprod LLC (Eagleville, PA), and John Ferguson Design (Southampton, PA).
1. GOLD WINNER: EPIC Total Diode Solution, manufactured and submitted by BIOLASE Inc. (Irvine, CA). EPIC is a semiconductor diode laser system that facilitates three different types of dental treatment, including soft tissue surgical procedures, laser-assisted tooth whitening, and temporary relief of minor pain in the oral/maxillofacial region. Supply and design credit to Morphix Design (San Clemente, CA).
2. SILVER WINNER: Zimmer Trabecular Metal Dental Implant, manufactured and submitted by Zimmer Dental Inc. (Carlsbad, CA). The Trabecular Metal Dental Implant features an 80% porous, osteoconductive midsection that is structurally similar to bone. It facilitates bone ingrowth and ongrowth, and can replace one or more missing teeth in a variety of clinical conditions.
3. BRONZE WINNER: Carestream CS 8100 Digital Panoramic System, manufactured by Carestream Dental (Croissy-Beaubourg, Marne La Vallee, France). Entry submitted by Carestream Dental (Atlanta, GA). The CS 8100 makes positioning easier, image acquisition faster, and higher image quality more accessible, by blending advanced, sophisticated technology in an extremely simple and compact system.
4. FINALIST: 3M ESPE Intra-Oral Syringe, manufactured and submitted by 3M Deutschland GmbH, 3M ESPE Division (Seefeld, Germany). The Intra-Oral Syringe is a single-use delivery and mixing device for the precise placement of wash impression materials. It’s ergonomic and hygienic. Less impression material is wasted because it can be prefilled 12 hours prior to application. Supply and design credit to Hack Formenbau (Kirchheim Teck, Baden Wurttemberg, Germany).
1. GOLD WINNER: Dansac NovaLife 1 & 2 Ostomy Pouches, manufactured and submitted by Dansac A/S (Fredensborg, Denmark). Dansac NovaLife 1 & 2 is a series of open and closed ostomy pouches in a 1 and 2 piece version. The purpose of the Dansac NovaLife ostomy pouch is to collect the faeces let out through an ostomy opening in the abdomen. Supply and design credit to Moller Jensen Innovation Design (Copenhagen, Denmark).
2. SILVER WINNER: Optiflow Junior Nasal Cannula, manufactured and submitted by Fisher & Paykel Healthcare (Manukau, Auckland, New Zealand). The Fisher & Paykel Healthcare’s Optiflow Junior is a next-generation nasal cannula which can deliver heated, humidified blended gas to patients in respiratory distress, ranging in sizes to fit premature babies to pediatric children.
3. BRONZE WINNER: PowerGlide Midline Catheter, manufactured and submitted by Bard Access Systems (Salt Lake City, UT). The PowerGlide Midline Catheter offers an all-in-one insertion mechanism with an integrated guidewire to assist with difficult IV sticks while the 8-10 cm body-softening catheter allows for dwell times up to 29 days, and can be used for power injection.
4. FINALIST: LUSTRE Pure Light Treatment for Acne, manufactured by Ambicare Health (Edinburgh, Scotland, United Kingdom). Entry submitted by Kinneir Dufort (Bristol, United Kingdom). LUSTRE Pure Light is a light technology to treat spots. It was developed by leading dermatologists and tested by healthcare professionals. It is the world’s first wearable device for the treatment of mild to moderate acne. Supply and design credit to Kinneir Dufort (Bristol, United Kingdom), and Solid Semecs (Uden, Netherlands).
4. FINALIST: Stryker Prime TC Transport Chair, manufactured and submitted by Stryker Medical (Portage, MI). The Prime TC transport chair is a safe, simple, and reliable seated transport device designed for the acute care environment. It improves the experience for the patient, care giver, and hospital. Supply and design credit to Michael Graves Design Group (Princeton, NJ).
4. FINALIST: ViSi Mobile comprehensive body-worn vital signs monitoring system, manufactured by Sotera Wireless Inc. (San Diego, CA). Entry submitted by Eastman Chemical Co. (Kingsport, TN). The ViSi Mobile System is a continuous, body-worn vital signs monitor that detects a patient’s condition and allows early intervention to prevent adverse events. The lens, housing and connectors are made with Eastman Tritan copolyester. Supply and design credit to Eastman Chemical Co. (Kingsport, TN), DDSTUDIO (Carlsbad, CA), Affinity Medical Technologies LLC (Costa Mesa, CA), and Phillips Plastics Corp. (San Diego, CA).
1. GOLD WINNER: GORE Septal Occluder, manufactured and submitted by W. L. Gore & Associates Inc. (Flagstaff, AZ). The GORE Septal Occluder is a permanent implant delivered via a transcatheter approach. It is used to treat congenital heart defects of the atrial septum: Atrial Septal Defect and Patent Foramen Ovale. It prevents shunting of the blood between the right and left atria.
2. SILVER WINNER: Cochlear Nucleus CR120 Intraoperative Remote Assistant, manufactured and submitted by Cochlear Ltd. (Macquarie University, NSW, Australia). The Cochlear Nucleus CR120 Intraoperative Remote Assistant is a wireless and intuitive to use hand-held device that performs fast diagnostics on the cochlear implant. It also measures neural responses to create a hearing profile for immediate hearing. Supply and design credit to In-Tech Electronics (Shenzhen, Guangdong, China), and Silicon and Software Systems Ltd. (Wroclaw, Poland).
3. BRONZE WINNER: Orthofix Ankle Compression Nailing System (ACN), manufactured by Orthofix Srl. (Bussolengo, Italy). Entry submitted by Orthofix Inc. (Lewisville, TX). The Ankle Compression Nailing System is an ankle fusion nail device consisting of an implant, screws, and locking caps. The implant is inserted through the base of the calcaneus into the medullary canal of the tibia via a radio-translucent dual targeting arm. Supply and design credit to AIP Precision Machining (Daytona Beach, FL), Orchid Arcadia (Arcadia, CA), and Orchid Design (Shelton, CT).
4. FINALIST: ATI Neurostimulation System, an implantable neurostimulator device that targets the sphenopalatine ganglion (SPG) for the treatment of severe headache, manufactured and submitted by Autonomic Technologies Inc. (Redwood City, CA). The ATI Neurostimulation System is a small, minimally invasive, rechargeable implant designed for the facial anatomy. It is activated by a patient-controlled remote controller to deliver as-needed stimulation to relieve a headache attack.
4. FINALIST: DynaNail Ankle Arthrodesis Nail, manufactured and submitted by Medshape Inc. (Atlanta, GA). DynaNail is intended for tibiotalocalcaneal arthrodesis procedures. With its internal pseudoelastic nitinol element, DynaNail provides the sustained compression of an external fixator, while having the low profile and rigidity of an intramedullary nail.
4. FINALIST: Nucleus CI422 cochlear implant with Slim Straight Electrode, manufactured and submitted by Cochlear Ltd. (Macquarie University, NSW, Australia). The Nucleus CI422 cochlear implant (CI422 implant) features the Slim Straight Electrode, which enables surgical placement in the cochlea with minimal trauma. This technology supports preservation of the existing, delicate structures in the cochlea.
2. SILVER WINNER: EDGE Platform, manufactured and submitted by HTG Molecular Diagnostics Inc. (Tucson, AZ). The HTG EDGE Platform is a research and clinical tool that fully automates the RNA expression analysis process in less than 24 hours. The proprietary HTG qNPA technology enables mRNA quantitation without time-consuming extraction, amplification, or synthesis.
3. BRONZE WINNER: Irys genomics platform, manufactured by BioNano Genomics (San Diego, CA). Entry Submitted by Sparton Medical (Strongsville, OH). Irys is an automated high-resolution single-molecule imager to analyze linearized single DNA molecules in IrysChip nanochannel arrays. The system allows the study of unique aspects of genomes that cannot currently be detected by other methods. Supply and design credit to Sparton Medical (Strongsville, OH), and HS Design Inc. (Gladstone, NJ).
4. FINALIST: Vantera Clinical Analyzer, manufactured and submitted by LipoScience Inc. (Raleigh, NC). The Vantera Clinical Analyzer automatically measures clinical serum samples via NMR to create digitized spectral data and report multiple analyte concentrations from a single sample. It includes a NMR spectrometer, automated fluidics, and software. Supply and design credit to KMC Systems Inc. (Merrimack, NH), and Agilent Technologies Inc. (Santa Clara, CA).
2013 READERS CHOICE WINNER: t:slim Insulin Pump, The t:slim was selected by popular vote on MDDIonline.com’s first ever MDEA Readers’ Choice poll. The entire community of MD+DI readers weighed in on their choice for the top MDEA finalist product. More than 4,200 readers voted...and the 2013 winner was t:slim, manufactured and submitted by Tandem Diabetes Care Inc. (San Diego, CA). The t:slim is the first touchscreen insulin pump for people with diabetes. Its smartphone-style interface is simple to teach, learn, and use. The slimmest pump available, t:slim holds 300 units of insulin and uses a rechargeable battery.
1. GOLD WINNER: Lantus & You Journal for Lantus SoloSTAR (insulin glargine [rDNA origin] injection pen), manufactured by Sanofi (Bridgewater, NJ). Entry submitted by IDEO (Boston, MA). The Lantus & You Journal supports patients with type 2 diabetes who are new to using the Lantus SoloSTAR insulin injection pen by offering them an easy, step-by-step guide and a calming experience during their first 7 days of treatment. Supply and design credit to IDEO (Boston, MA), and HAVAS Life NY (New York, NY).
1. GOLD WINNER: new Glucose Sensor Serter, manufactured and submitted by Medtronic Minimed (Northridge, CA). The new glucose sensor insertion device (not approved in the USA) is used by people with diabetes who use the Paradigm Veo insulin pump with built-in continuous glucose monitoring. It is used to insert the glucose sensor beneath the skin. Supply and design credit to Bridge Design (San Francisco, CA).
2. SILVER WINNER: SpeediCath Compact Set ready-to-use coated catheter in sterile solution with attached bag, manufactured and submitted by Coloplast A/S (Humlebaek, Denmark). The SpeediCath Compact Set is intended for urine bladder drainage through the urethra. The catheter is attached to a urine bag for collection of urine. The product is a single-use sterile device. Supply and design credit to Native Design Ltd. (London, United Kingdom).
3. BRONZE WINNER: Masimo iSpO2 Pulse Oximeter and the iSpO2 App available in the AppleApp Store, manufactured and submitted by Masimo Corp. (Irvine, CA). Masimo’s iSpO2 is a measure-through-motion and low-perfusion pulse oximeter made for the iPhone and iPad. It allows noninvasive tracking of blood oxygen, pulse, and perfusion index. The system creates a graphic of measurement over time that can be e-mailed.
4. FINALIST: AllStar Reusable Insulin Delivery Device, manufactured by Sanofi India Ltd. (Mumbai, India). Entry submitted by DCA Design International (Warwickshire, United Kingdom). AllStar is a reusable insulin pen, produced by a global company in India. Developed especially for patients in emerging markets, AllStar conforms to ISO standards and is equipped with state-of-the-art features. Supply and design credit to DCA Design International (Warwick, Warwickshire, United Kingdom), Sanofi Aventis Deutschland GmbH (Frankfurt am Main, Germany), Shaily Ltd. (Gujarat, India), Unitech Technology Yeh Corp. (South Dist, Tainan City, Taiwan ROC), Clamason Industries Ltd. (West Midlands, United Kingdom), Smalley Steel Ring Co. (Lake Zurich, IL), Promedix GmbH (Darmstadt, Germany), Chapel Technical Projects Ltd. (Cheshire, United Kingdom), and Linki Ltd. (Sandbach, United Kingdom).
4. FINALIST: FreeStyle InsuLinx Blood Glucose Monitoring System, manufactured by Abbott Diabetes Care (Alameda, CA). Entry submitted by Bridge Design (San Francisco, CA). The FreeStyle InsuLinx Blood Glucose Monitoring System is a touchscreen meter that helps calculate the correct insulin doses and makes insulin-dosing suggestions. A clinician programs the system for each patient. Supply and design credit to Bridge Design (San Francisco, CA).
4. FINALIST: NovoPen 5 insulin pen with memory function, manufactured by Novo Nordisk A/S (Copenhagen, Denmark). Entry submitted by ESP Bioscience (Crowthorne, Berkshire, United Kingdom). NovoPen 5 is a new durable insulin pen with an easy-to-use memory function designed for peace of mind. The memory function meets a key need of people with diabetes, the dilemma of when they took their last dose and how much insulin they injected.
1. GOLD WINNER: Acessa minimally invasive, outpatient therapy for treating uterine fibroids, manufactured and submitted by Halt Medical Inc. (Brentwood, CA). Acessa is a minimally invasive, outpatient therapy for treating fibroids using radiofrequency volumetric thermal ablation. Each fibroid is destroyed by applying energy through a small needle array. The normal function of the uterus is preserved. Supply and design credit to CullDez Product Development (Livermore, CA), Aim Design (Brentwood, CA), Dean Miller Associates (Menlo Park, CA), Bruxton Corp. (Seattle, WA), and Know-How Consulting (Honolulu, HI).
2. SILVER WINNER: Liposonix Custom Contouring, manufactured by Solta Medical (Hayward, CA). Entry submitted by General Assembly (Seattle, WA). Liposonix is a proven, unique, and effective aesthetic device built on high-intensity ultrasound technology focused on the removal of stubborn fat cells. Liposonix is used by doctors to provide a safe, noninvasive, nonsurgical alternative to liposuction. Supply and design credit to General Assembly (Seattle, WA).
3. BRONZE WINNER: Avedro KXL System for accelerated corneal crosslinking, manufactured and submitted by Avedro (Waltham, MA). The KXL System achieves accelerated-crosslinking by increasing UVA power and reducing procedure time from one hour to a few minutes. It maintains the same energy on the eye as standard cross-linking in a faster, more predictable procedure.
4. FINALIST: UltrOZ Elite wearable ultrasonic therapy system, manufactured by ZetrOZ (Trumbull, CT). Entry submitted by Influence & Co. (Columbia, MO). UltrOZ is a wearable ultrasonic therapy system for the treatment of common musculoskeletal conditions in horses. UltrOZ has been used successfully to treat splints, suspensory ligaments and tendons, muscle strains, stiff joints, arthritis, and fractures.
1. GOLD WINNER: Rifton TRAM transfer and mobility device, manufactured and submitted by Rifton Equipment (Rifton, NY). The Rifton TRAM, a transfer and mobility device, combines three powerful functions in one compact frame. These functions include seated transfers, sit-to-stand lifts and gait training.
2. SILVER WINNER: mySentry Remote Glucose Monitor, manufactured and submitted by Medtronic Diabetes (Northridge, CA). mySentry is the world’s first remote glucose monitor of an integrated insulin pump with CGM. It is designed to enhance nighttime protection with sensor alerts and alarms that awaken the caregiver of a person with diabetes to convey important information. Supply and design credit to Flextronics Industrial (Shenzhen) Co. Ltd. (Shenzhen, Guangdong, China).
3. BRONZE WINNER: t:slim Insulin Pump, manufactured and submitted by Tandem Diabetes Care Inc. (San Diego, CA). The t:slim Insulin Pump is the first touchscreen insulin pump for people with diabetes. Its smartphone-style interface is simple to teach, learn, and use. The slimmest pump available, t:slim holds 300 units of insulin and uses a rechargeable battery.
4. FINALIST: Ambio Remote Health Monitoring System, manufactured by and submitted by Arrayent Health LLC, dba Ambio Health (Stamford, CT). Ambio is the first consumer-affordable, easy-to-use, home health monitoring system. A central gateway communicates wirelessly to health devices anywhere in the home. The web-based Care Portal keeps all stakeholders engaged for improved health. Supply and design credit to Night Owl Interactive (New York, NY), and HS Design Inc. (Gladstone, NJ).
4. FINALIST: Genesis Touch wireless remote patient monitoring device, manufactured and submitted by Honeywell HomMed (Brookfield, WI). The Genesis Touch is a wireless remote patient monitoring device that enables ongoing or transitional patient health management, including disease management and wellness coaching. Supply and design credit to Samsung Mobile (San Diego, CA).
4. FINALIST: ResMed Pixi Paediatric Mask, manufactured and submitted by ResMed Ltd. (Sydney, Australia). The Pixi paediatric mask is intended for children aged 2-7 for whom continuous positive airway pressure or bilevel therapy has been prescribed. Pixi is a nasal mask designed to provide a stable, effective air seal with minimum headgear tension. Supply and design credit to IDE Group (Sydney, Australia).
1. GOLD WINNER: Sonicision Cordless Ultrasonic Dissection System, manufactured and submitted by Covidien (Boulder, CO). Sonicision is a cordless ultrasonic dissection device indicated for soft-tissue incision and hemostasis in a variety of surgical procedures. It is a hand-held, pistol-grip-style, battery-powered surgical ultrasonic device.
2. SILVER WINNER: NeoChord DS1000 Chordae Replacement System, manufactured by NeoChord Inc. (Eden Prairie, MN). Entry submitted by Worrell Design Inc. (Minneapolis, MN). The NeoChord DS1000 is a disposable device intended to replace damaged chordae by delivering artificial chordae tendinae, or neochords, in a beating heart using minimally invasive techniques. Supply and design credit to Worrell Design Inc. (Minneapolis, MN).
3. BRONZE WINNER: FORNISEE Lighted Uterine Manipulator System, manufactured and submitted by LSI SOLUTIONS (Victor, NY). The McCarus-Volker FORNISEE System is the world’s first lighted uterine manipulator product. This technology enhances tissue identification, remote manipulation of the uterus, and surgical ergonomics during laparoscopic hysterectomies.
4. FINALIST: Adherus AutoSpray Dural Sealant, manufactured and submitted by HyperBranch Medical Technology (Durham, NC). Adherus AutoSpray is designed for the controlled application of HyperBranch’s dural sealant. AutoSpray significantly improves the assembly and delivery process, provides smooth application, and does not clog during stop and start operations.
4. FINALIST: Aquamantys3 BSC 9.1S bipolar sealer with cutting, manufactured by Medtronic Advanced Energy LLC (Portsmouth, NH). Entry submitted by Continuum Advanced Systems (West Newton, MA). The Aquamantys3 BSC 9.1S is a hand-activated, single-use electrosurgical instrument using transcollation technology to provide low-temperature hemostatic sealing and an integrated monopolar cutting function. It is intended for orthopedic procedures. Supply and design credit to Continuum Advanced Systems (West Newton, MA).
4. FINALIST: iDrive Ultra Powered Stapling System, manufactured and submitted by Covidien (North Haven, CT). The iDrive Ultra Powered Stapling Device (with Covidien’s Endo GIA stapling reloads) provides precision in surgical stapling, enabling surgeons to position and keep the stapler exactly where they intend, using only one hand and a push button. Supply and design credit to Preferred Tool and Die Inc. / Preferred Precision (Shelton, CT).