MDEA 2018 Winners

AeroForm Tissue Expander System
irXpanders

Representing the first major change in breast tissue expansion in almost 40 years, the AeroForm Tissue Expander System is the first and only needle-free, patient-controlled, wireless, tissue expander system for women who choose to have reconstructive surgery following a mastectomy.

CleanCision
Prescient Surgical

The CleanCision™ Wound Retraction and Protection System is the first in a new FDA device class developed to retract the surgical incision, provide abdominal access, and consistently and continuously irrigate the wound edge with a surgeon-selected fluid therapy to actively fight and remove the root cause of surgical site infection--wound contamination--without disrupting current surgical practice.

Cardiovascular Devices

MoMe Kardia 
InfoBionic

 The MoMe Kardia ambulatory electrocardiograph (ECG) monitoring wearable is designed for patients with transient symptoms of cardiac arrhythmia. It acquires, stores and sends ECG and other related data. This is continuously transmitted and can be flagged for physician review on a Web-based portal.

HyperView
HyperMed Imaging Inc.

The HyperView System is used by healthcare professionals as a noncontact tissue oxygenation measurement system.  The HyperView utilizes noninvasive, nonionizing hyperspectral imaging technology to assess tissue oxygenation in cases involving local, regional, and systemic flow ischemia.  The device displays color coded images and reports oxyhemoglobin levels, deoxyhemoglobin levels, and oxygen saturation in the superficial tissue.

AC3 Optimus Intra-aortic Balloon Pump
Teleflex Medical, Inc.

The AC3™ Optimus Intra-aortic Balloon Pump provides counterpulsation therapy to adult patients with impaired left ventricular function.  It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles.  The pump is attached to an balloon catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta.

Drug-Delivery and Combination Products

SURGICEL Powder Absorbable Hemostat
Ethicon US LLC

SURGICEL® Powder Absorbable Hemostat provides a solutions to stop continuous, broad-surface oozing and bleeding fast, even on friable or raw tissue when other conventional methods are impractical or ineffective1,2. The unique structure of the powder penetrates the surface of the blood to get to the sources of bleeding1,3 and is also proven bactericidal against pathogens6-8.

Eli Lilly Taltz Injection Devices 
Eli Lilly and Company, in collaboration with IDEO

The Taltz injectors are designed to treat people with moderate to severe plaque psoriasis and psoriatic arthritis with Eli Lilly and Company’s Taltz™ medication. The devices come in both autoinjector and prefilled-syringe form.

Methofill (methotrexate) SELF INJECT
Accord Healthcare Limited 

West’s SelfDose® injector is a handheld device that is designed to help patients self-administer a subcutaneous injection. The device is part of a combination product that is supplied to patients with a standard 1mL prefilled syringe already loaded inside. Its overall design makes it easy to use for individuals struggling with dexterity challenges.

OnSite-IV
PharmaC LLC

The OnSite-IV® is a single use device that facilitates creation of a sterile fluid path to transfer liquid from the syringe body to a  vial for delivery into an IV bag or elastomeric device.   The device provides both admixture and direct dispensing of medications.

ER and OR Tools, Equipment, and Supplies

VersaOne Fascial Closure System 
Medtronic Inc. 

The VersaOne™ fascial closure system is a novel all-in-one solution that serves as a trocar and a fascial closure device to deliver consistent port-site closure, added procedural efficiency, and ease of use.  This system allows for the trocar to remain within the patient while closing the defect, allowing for tissue alignment and pneumoperitoneum.

Minne Ties Agile MMF
Summit Medical LLC

Minne Ties® Agile MMF is an innovative approach to achieving maxilla-mandibular fixation (MMF). Our system is a non-invasive solution that provides a steady force and secure bite to allow for closed reduction fracture management or stabilization for internal fixation. Minne Ties is a safe, simple and efficient alternative to existing wire or hybrid devices.

CleanCision
Prescient Surgical

The CleanCision™ Wound Retraction and Protection System is the first in a new FDA device class developed to retract the surgical incision, provide abdominal access, and consistently and continuously irrigate the wound edge with a surgeon-selected fluid therapy to actively fight and remove the root cause of surgical site infection--wound contamination--without disrupting current surgical practice.

Implant and Tissue-Replacement Products

AeroForm Tissue Expander System
AirXpanders

Representing the first major change in breast tissue expansion in almost 40 years, the AeroForm Tissue Expander System is the first and only needle-free, patient-controlled, wireless, tissue expander system for women who choose to have reconstructive surgery following a mastectomy.

Truliant Knee System
Exatech

Truliant® is a comprehensive system that addresses clinical challenges in primary and revision total knee replacement. With its streamlined and intuitive design, Truliant offers orthopaedic surgeons the prostheses and tools they need to achieve more accurate and reproducible clinical results through an improved surgical experience. 

SPEEDTRAP Graft Preparation System 
DePuy Synthes Companies

The SPEEDTRAP Graft Preparation System is used in preparing soft-tissue grafts in orthopedic procedures. The suture uses a fingertrap technique to compress rather than pierce the graft, and its needleless design reduces graft preparation time by 77% compared with standard techniques.

Nonsurgical Hospital Supplies and Equipment

Equashield Pro Pharmacy Robot
Equashield

Patient-Specific IV Drug preparation is one of the most critical and error-prone practices within a hospital pharmacy.  Equashield Pro automates today's manual hazardous drug compounding with use of its high throughput robot that is designed around manufacturing concepts and does not rely on human hands, like current robots on the market.

Flusso
McArthur Medical Sales, Inc.

Flusso is a bypass adapter that can be used with passive or active humidity systems to prevent the disconnection of the patient from the mechanical ventilator during a circuit change or disconnection of patient for transport.

Linked Visibility Inventory System
IntelliGuard

The IntelliGuard® Linked Visibility Inventory Station™  or LVIS™ offers ideal caregiver medication access at the point-of-care and remote pharmacy visibility enterprise-wide.  Our solution is expected to be user-friendly to end-user anesthesiologists and provide the inventory visibility required by pharmacists for medications dispensed to the operating room environment.

Over-the-Counter and Self-Care Products

Willow Breast Pump
Willow, in collaboration with IDEO

Willow is the first all-in-one breast pump that fits inside a bra. Mobile, discreet, and hands-free, Willow allows women to achieve their breastfeeding goals without pressing pause on life.

MediClear PreOp
Covalon Technologies Ltd.

MediClearTM PreOp is the first FDA cleared dual antimicrobial self-adherent silicone film drape for preoperative skin. Worn prior to surgery to cover and protect the incision site, chlorhexidine and silver embedded silicone adhesive provide constant broad-spectrum antimicrobial protection, while its transparent polyurethane backing acts as a barrier to external sources of contamination.

ZipStitch
ZipLine Medical, Inc.

Why Stitch It, When You Can Zip It?  Introducing ZipStitch, the most advanced wound closure device available without a prescription.  Now, virtually anybody can effectively treat minor cuts and lacerations in seconds, wherever they may be. No Needles. No stitches. No hassle.

Radiological, Imaging, and Electromechanical Devices

Exablate Neuro
INSIGHTEC

Exablate Neuro is an FDA-approved device used to treat essential tremor, a neurological condition that causes uncontrollable shaking that affects the daily lives of 41 million people worldwide. Exablate Neuro uses MR-guided focused ultrasound to perform surgery deep in the brain with no incisions.

StealthStation S8
Medtronic, plc

The Medtronic StealthStation™ S8 is a visualization and surgical navigation system for precisely locating anatomical structures in either open or percutaneous procedures. The system features optical and electromagnetic localization technologies, robust processing power, intuitive software workflows, and a flexible system architecture to assist clinicians during cranial, spine, and ear-nose-throat procedures.

OmniTom
Samsung NeuroLogica

OmniTom® is a 16-slice CT scanner that delivers the highest quality non-contrast, CT angiography, and CT perfusion scans at the point-of-care. The combination of rapid scan time, ultra-small footprint, and immediate image viewing makes OmniTom an indespensable tool for collecting real time data on critically ill patients.

Rehabilitation and Assistive-Technology Products

Obi
DESĪN

For individuals lacking upper extremity function, Obi gives the diner control over food selection, delivery and restores a more independent, relaxed and social dining experience.  This lifestyle transformation is created through applied manipulator technology at a scale, price, and level of usability that has never before existed in assistive technology. 

Ebb Insomnia Therapy
Ebb Therapeutics

Ebb Insomnia Therapy is the first and only FDA-cleared medical device that reduces the time it takes to both fall asleep and enter deep, restorative sleep. A comfortable, night-time wearable, Ebb comfortably cools your forehead, helps quiet the racing mind and enhances your ability to sleep.

Podimetrics Remote Temperature Monitoring System
Podimetrics, Inc.

The Podimetrics Remote Temperature Monitoring System is a technology for inflammatory foot diseases such as foot ulcers, a common and costly complication of diabetes. It consists of a daily-use telemedicine mat and an online portal for clinical decision support, enabling targeted and timely preventative care and improved population health management.

Testing and Diagnostic Products and Systems

STERRAD VELOCITY Biological Indicator System
Advanced Sterilization Products (ASP), part of Johnson & Johnson Medical Devices Companies 

STERRAD VELOCITY™ Biological Indicator (BI) System is a hydrogen peroxide (H202) BI that confirms proper sterilization of reprocessed surgical instruments within 30 minutes, rather than 24 hours like other systems. STERRAD VELOCITY™ Reader integrates with STERRAD® sterilizers and uses advanced optical measurement technology. It includes automated record keeping, compliance checks, and on-screen instructions.

APAS Independence
Clever Culture Systems

APAS Independence is a stand-alone automated culture plate reading instrument that consistently screens and sorts 200 Petri dishes per hour. The innovative triage system identifies negative plates and removes them from the workflow. This allows microbiologists to focus their expertise on the significant plates, accelerating reporting of patient results.

Panther Fusion system
Hologic, Inc.

The Panther Fusion module is an in-lab upgrade to the Panther® instrument. This full random-access system consolidates testing with a growing menu of respiratory, virology, women’s health and STI assays on a single instrument. The Panther Fusion system also features multiple amplification technologies, including PCR capability to their proven TMA technology.