• Simplexa Direct and Simplexa Universal Direct assay kits. Manufactured and submitted by Focus Diagnostics (Cypress, CA).

    Simplexa Direct and Simplexa Universal Direct assay kits employ a technology to overcome limitations of other molecular tests: extracting nucleic acids. These assays provide rapid and definitive results within an hour, the time classic real-time PCR requires for nucleic extraction.

  • SnapPath 1000 biomarker testing system. Manufactured by BioMarker Strategies (Baltimore, MD). Entry submitted by HS Design Inc. (Gladstone, NJ). Supply and design credit to HS Design Inc., Sparton Medical Systems (Strongsville, OH), and Mack Molding (Arlington, VT).

    The SnapPath 1000 biomarker testing system is an automated live tumor cell-processing instrument that enables predictive diagnostics. SnapPath data helps medical oncologists determine the best treatment options for individual cancer patients.


    1. New prefilled insulin injection pen. Manufactured by Novo Nordisk A/S (Hillerød, Denmark). Entry submitted by ESP Bioscience (Crowthorne, Berkshire, UK).

      This new prefilled insulin injection pen has a unique spring-loaded mechanism. The pen has a no push-
      button extension at any dose and a low injection force, designed to make self-injecting easier for people with diabetes.

    2. Vibrance Kegel Device. Manufactured and submitted by Bioinfinity (M) Sdn Bhd (Kuala Lumpur, Malaysia).

      The Vibrance Kegel Device provides active biofeedback and audio-guided interval training to assist women in performing pelvic floor exercises correctly.


    1. BodyTom portable, full body, multi-slice CT scanner. Manufactured and submitted by NeuroLogica Corp. (Danvers, MA).

      BodyTom is a portable CT scanner that provides full body, 32-slice imaging with an 85-cm gantry and 60-cm field of view. The device enables rapid scan time, flexible settings, and immediate image viewing for versatile, real-time CT imaging.

    2. Carestream CS 7600 imaging plate system. Manufactured and submitted by Carestream Health Inc. (Rochester, NY). Supply and design credit to Orex Computed Radiography Ltd. (Yoqneam, Israel).

      The Carestream CS 7600 is an intraoral imaging plate system featuring an automated, secure workflow designed to improve productivity and user experience. It enables operators to use the system on multiple patients at the same time, with no waiting and no risk of errors.

    3. DermScope imaging accessory for the iPhone. Manufactured by Canfield Scientific Inc. (Fairfield, NJ). Entry submitted by HS Design Inc. (Gladstone, NJ). Supply and design credit to HS Design Inc

      The DermScope is an accessory for the iPhone 4 and 4s. It consists of a controlled lighting system, optical interface, and proprietary software that enables dermatascopic image viewing and capture using the iPhone’s camera and display.

    4. NOMAD Pro handheld x-ray system. Manufactured by Aribex Inc. (Orem, UT). Entry submitted by IQMS (Paso Robles, CA). Supply and design credit to Voltage Multipliers Inc. (Visalia, CA), and Ecomass Technologies (Austin, TX).

      NOMAD Pro is an advanced, handheld intraoral x-ray for dental professionals that can easily be used in or out of an office setting. Lightweight and rechargeable, NOMAD Pro helps provide underserved patients access to care in remote humanitarian programs.

    5. Planmed Verity extremity scanner. Manufactured and submitted by Planmed Oy (Helsinki, Finland).

      Planmed Verity is a mobile 3-D imaging device designed for extremity imaging at the point of care. Its purpose is to catch often-missed fractures in the extremities. It provides preoperative imaging at a lower radiation dose than full-body CTs.


    1. BiOM Ankle prosthetic device. Manufactured and submitted by iWalk Inc. (Bedford, MA). Supply and design credit to Cogmedix (West Boylston, MA), OnCore Manufacturing Services (Springfield, MA), and Maxon Motors (Fall River, MA).

      The BiOM Ankle prosthetic device restores normal biological function for lower limb amputees, BiOM ankles used on wounded warriors resulted in energy costs, self-selected walking speeds, and biomechanic patterns that similar to non-amputees.

    2. Breathe NIOV Ventilation System. Manufactured and submitted by Breathe Technologies Inc. (Irvine, CA). Supply and design credit to AOK Tooling LTD. (Cheung Sha Wan, Kowloon, Hong Kong), ATL Technology (Springville, UT), AARCEE Consulting (Fremont, CA), Apogee Industrial Design (Millford, CT), and PN Engineering (Carlsbad, CA).

      The Breathe NIOV Ventilation System is a 1-lb wearable, non-invasive ventilation system that aids adults with respiratory insufficiency. It is designed to promote patient ambulation in institutional and home environments.

    3. Neptune sound processor. Manufactured by Advanced Bionics LLC (Vlencia, CA). Entry submitted by Product Creation Studio (Seattle). Supply and design credit to Product Creation Studio.

      Neptune is the first swimmable and fully submersible cochlear implant sound processor. Lightweight and waterproof, Neptune enables users to be able to hear in all environments. Worn off the ear, Neptune is more comfortable and convenient for users.

    4. Niagara Foot field-adjustable prosthetic device. Manufactured and submitted by Niagara Prosthetics and Orthotics International Ltd. (Fonthill, ON, Canada). Supply and design credit to DuPont Canada (Mississauga, ON, Canada), Human Mobility Research Centre, Queen’s University (Kingston, ON, Canada), Centennial Plastics Mfg. Ltd. (Mississauga), Hippo Design (Saint-André-Avellin, QC, Canada), Logique 3D/Instadesign (Montreal Laval, QC, Canada), Services PRÉCICAD Inc. (Quebec, Canada), and Universidad Don Bosco (Kempten, Germany).

      The Niagara Foot is an affordable, effective, and field-adjustable prosthetic that can be used anywhere in the world. Prosthetists can tune the heel stiffness, forefoot stiffness, and resistance to dynamic loading to meet patient needs, even in the field.

    5. RT600 Functional Electrical Stimulation (FES) stepper ergometer featuring SAGE smart stimulation system. Manufactured and submitted by Restorative Therapies Inc. (Baltimore). Supply and design credit to Apogee Designs Ltd. (Baltimore).

      The RT600 is a motorized Functional Electrical Stimulation (FES) stepper ergometer for rehabilitation of adult and pediatric patients with neurological injury or impairment. It is the only partial body weight supported stepping system fully integrated with FES.

    6. SIM (Smart Incontinence Management). Manufactured and submitted by Simavita Pty. Ltd. (North Sydney, Australia).

      SIM (Smart Incontinence Management) is an automated continence monitoring process removes the guesswork associated with a manual assessment and improves patients’ health outcomes.


    1. The ActiViews CT-Guide navigation system. Manufactured and submitted by ActiViews Inc. (Wakefield, MA).

      The ActiViews CT-Guide navigation system is designed to assist physicians during CT-guided interventional procedures by continuously tracking and displaying the location of a navigated instrument in relation to the CT image of the patient’s anatomy.

    2. Alair Catheter for Bronchial Thermoplasty procedures. Manufactured by Asthmatx (Sunnyvale, CA). Entry submitted by Bridge Design (San Francisco). Supply and design credit to Bridge Design.

      Alair treats severe asthma with bronchial thermoplasty. Introduced into the lungs by a bronchoscope, it delivers radio frequency energy to the airway wall, reducing airway smooth muscle to decrease constriction and reduce the frequency of asthma attacks.

    3. Catalys Precision Laser System. Manufactured and submitted by OptiMedica Corp. (Santa Clara, CA). Supply and design credit to LUNAR (San Francisco), and 219 Design LLC (Mountain View, CA).

      The Catalys is a next-generation laser cataract surgery system that allows surgeons to perform image-guided, preoperative laser lens conditioning with unparalleled accuracy and a greatly streamlined workflow.

    4. EndoSerter Corneal Endothelial Delivery Instrument. Manufactured by Ocular Systems Inc. (Winston-Salem, NC). Entry submitted by Cathtek LLC (Winston Salem). Supply and design credit to Cathtek LLC.

      The EndoSerter is a sterile, disposable, single-use device used by ophthalmologists during Descemets Stripping Endothelial Keratoplasty procedures to insert a corneal endothelial allograft into the anterior chamber of a patient’s eye.

    5. FMwand Ferromagnetic Surgical System. Manufactured and submitted by Domain Surgical (Salt Lake City). Supply and design credit to Eclipse Product Development and Biomerics LLC (both Salt Lake City).

      FMwand Ferromagnetic Surgical System precisely cuts and coagulates soft tissue while minimizing collateral damage, making it ideal for use in neurosurgery, spine surgery, and subspecialties requiring precision and safety near delicate structures.

    Winning products will be announced at the MDEA Presentation Ceremony held on Wednesday,May 23, 2012 at 4:30 pm during a cocktail reception inside the Philadelphia Marriott Downtown hotel. The ceremony is held in conjunction with the MD&M East Event (www.MDMEast.com) at the adjacent Pennsylvania Convention Center, May 22-24. At the ceremony: — The 2012 MDEA-finalists, and their suppliers, will be honored for their innovative contributions to the medical device industry.

    — Up to one Bronze, one Silver, and one Gold-winning product will be announced in each category.

    — One Gold-winning product will be awarded “Best-in-Show”.

    — The NCIIA will announce the winners of the 2012 BMEidea biomedical engineering competition for university students.

    — Famed inventor Dr. Thomas Fogarty will be presented with the prestigious 2012 MDEA Lifetime Achievement Award for his contributions over a long career that have had a demonstrable impact on technological, business, and cultural advancements in medical devices.

    The 2012 Medical Design Excellence Awards are sponsored by Platinum Sponsor: Phillips-Medisize and Silver Sponsor: Teleflex Medical OEM.

    source:  http://www.MDEAwards.com



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    1. 41 Innovative Products Selected as Finalists in 2012 Medical Design Excellence Awards | Electrician Dallas

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