Critical-Care & Emergency Medicine Products
SERVO-U & SERVO-n, ICU Ventilators, manufactured and submitted by Maquet Critical Care (Sweden)
Maquet and Veryday have created the most accessible and easy-to-use ventilators on the global market. These pioneering products offer a modern user experience and an intuitive interface, and are part of improving quality of life for patients, families and caregivers.
Wound Hub ii, manufactured and submitted by Wondermed (Ptt) Lt (South Africa)
The wound hub 11 provides all aspects of advanced wound treatment in a single machine. Cleaning, debriding, irrigating, drying, applying creams and massaging. It is marketed as a "theatre in a box".
Diagnostic Products and Systems
Cologuard, manufactured and submitted by Exact Sciences Corp (USA)
Cologuard, developed by Exact Sciences, is a noninvasive screening test for colorectal cancer (CRC) designed to help increase rates of screening compliance and, long term, help eradicate the disease.
Bacterioscan Laser Microbial Growth Monitor, manufactured and submitted by BacterioScan, Inc. (USA)
The BacterioScan 216R Laser Microbial Growth Monitor delivers accurate detection of UTI from patient specimens within 90 minutes, reducing lab time-to-result by >90% for the vast majority of patients, saving lab cost and labor, and reducing unwarranted use of antibiotics.
EPIQ, manufactured and submitted by Philips North America (USA)
Introducing a new era in premium ultrasound. Philips´ new EPIQ platform delivers extraordinary image resolution and detail along with exceptional levels of information. EPIQ is built on Philips proprietary nSIGHT Imaging architecture which introduces a totally new approach to forming ultrasound images without compromise. nSIGHT Imaging breaks the rules of conventional ultrasound to achieve new levels of clinical performance. Philips EPIQ. Epic in every way.
Drug-Delivery Devices and Combination Products
EVARREST Fibrin Sealant Patch, manufactured and submitted by Ethicon (USA)
EVARREST™ is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.
DuoResp Spiromax, manufactured and submitted by Teva Pharmaceuticals Europe (United Kingdom)
DuoResp Spiromax is a dry powder inhaler containing existing medicines for asthma and COPD, in a new device. Its proven intuitiveness means patients need less inhaler technique training, and its mechanism provides consistent drug delivery across inspiratory flow rates.
Evzio Naloxone Auto-Injector, manufactured and submitted by Kaleo Pharma, Inc. (USA)
With drug poisoning now being the leading cause of accidental death in America, kaléo invented Evzio® as the World´s First and Only take-home, hand-held, single-use naloxone auto-injector for immediate administration as emergency treatment of known or suspected opioid overdose.
General Hospital Devices and Therapeutic Products
Root, manufactured and submitted by Masimo (USA)
Root, with its high-definition, touchscreen display and multiple networking/connectivity options, offers an open-innovation platform for third-party developers, and helps caregivers make quicker patient assessments, earlier interventions, and better clinical decisions. It is also a base station for Masimo\\\\\\\'s legacy device the handheld transport monitor named Radical-7 or it\\\\\\\'s new wearable called Radius-7.
Progressa Bed System, manufactured and submitted by Hill-Rom, Inc. (USA)
The Progressa Bed System is designed to treat and prevent complications of immobility, to decrease patient migration, and to reduce healing time with proven technologies. Progressa is designed to offer a superior experience for patients, caregivers, and providers alike.
Valedo, manufactured and submitted by Hocoma (Switzerland)
Valedo is the first personal digital back coach for guided exercising of the lower back. Valedo is a certified consumer medical device and purpose-driven wearable technology with sophisticated, intuitive software. Valedo transforms therapeutic exercises into fun, interactive games.
Implant and Tissue-Replacement Products
Kiva Verterbal Compression Fracture Treatment System, manufactured and submitted by Benvenue Medical (USA)
Kiva is an innovative spinal implant for treating vertebral compression fractures due to osteoporosis and cancer. Through a minimally invasive access, Kiva expands within the vertebra into a robust cylindrical structure that stabilizes fractures and even helps prevent new fractures.
StabiLink - Spinal Fixation System, manufactured and submitted by Southern Spine LLC (USA)
The StabiLink® MIS Spinal Fixation System is a less invasive option to pedicle screws for spinal fusion procedures. Benefits include smaller incisions, significant reductions in blood loss, operative and recovery time, postoperative pain, resulting in quicker return to normal activities.
Corin OPS, manufactured and submitted by Optimized Ortho (Australia)
Every patient has a unique pelvic motion and physiological profile which can impact success of a Total Hip Replacement. Corin OPS™ technology provides preoperative information on patient targeted acetabular cup orientation through a patented dynamic hip analysis. A patient specific delivery system is then utilised to achieve the intended cup orientation during surgery.
BINARY Anterior Cervical Plate with Helios Technology, manufactured and submitted by Genesys Spine (USA)
The BINARY Anterior Cervical Plating System offers solutions to the most common design requirements of cervical plating systems with the benefit of a zero-step lock that does not sacrifice user friendliness, plate thickness, or functionality with respect to locking the screws.
Medical Product Packaging, Graphic Instructions, and Labeling Systems
AccuVax-Vaccine Management System, manufactured and submitted by TruMed Systems Incorporated (USA)
AccuVax is a custom-designed, high-performance, computerized, self-monitoring, cloud-connected, refrigerator/freezer vending machine for vaccine, solving major, every-day hassles for physician offices, clinics, hospitals, and pharmacies. AccuVax will enable a major Increase in immunization rates in currently under-served populations, particularly adults.
EVO, manufactured and submitted by SAVSU Technologies (USA)
Currently there is no assurance that temperature sensitive vaccines and biomaterials will be viable when shipped from origin to end user. The EVO shipper provides 100 hr temperature stability and relays critical data about the shipment in real time.
Over-The-Counter and Self-Care Products
SpeediCath Compact Eve, manufactured and submitted by Coloplast A/S (Denmark)
The woman before the product - A non-stigmatizing product SpeediCath-Compact-Eve is taking female catheters to new levels, by combining function with an aesthetic design. It is a ’ready-to-use’ compact coated catheter in sterile solution designed to be intuitive and easy-to-use.
Renew Insert, manufactured and submitted by Renew Medical Inc. (USA)
Renew Inserts softly and comfortably seal the rectum from the inside to protect against Accidental Bowel Leakage. Renew Inserts have been developed and clinically tested over 7 years and are proven to be safe, effective, comfortable and easy to use.
Womans Condom, manufactured and submitted by Shnaghai Dahua Medical Apparatus Co., Ltd. (China)
Womans Condom is a new, thin-film condom developed for ease of use and good sensation for both partners. A good option for protection from pregnancy and STIs, especially if your partner won’t use a male condom. Protection and pleasure combined for a global market.
Radiological and Electromechanical Devices
Corindus CorPath 200, manufactured and submitted by Corindus Vascular Robotics (USA)
The CorPath System is the first FDA-cleared system for robotic-assisted percutaneous coronary intervention (PCI) procedures, bringing robotic precision to PCI. CorPath helps optimize clinical outcomes while protecting interventional cardiologists from the dangers associated with radiation exposure during procedures.
Oraya IRay Radiotherapy System, manufactured and submitted by Oraya Therapeutics, Inc. (USA)
IRay is the first device using X-rays to treat wet Age-Related Macular Degeneration by precise dose and targeting to the retina’s diseased area. Treatments can reduce need for frequent eye injections. AMD is a leading cause of elder vision loss.
Sonata System, manufactured and submitted by Gynesonics (USA)
The Sonata System provides a uterus preserving, incision-free treatment option to women suffering from symptomatic uterine fibroids. Sonata combines a high resolution, compact sonography probe at the tip of a radiofrequency ablation device, providing a single handheld transcervical delivery system.
Rehabilitation and Assistive-Technology Products
Krabat Sheriff S2, manufactured and submitted by Krabat AS (Norway)
Indoor and outdoor use. Highly adaptable with numerous adjustment options.The child sits on a saddle seat. Widespread and innovative seating position creates a large base of support. This seating position is extremely important for a self mobility possibilities.
ReSound LiNX, manufactured and submitted by GN ReSound (Denmark)
ReSound LiNX is the world’s smartest hearing aid. With the most natural hearing experience available, ReSound LiNX tackles known challenges for the hearing impaired—all in a discreet design that allows for direct connectivity of smartphone controls and audio streaming.
Sam-Ultrasonic, manufactured and submitted by ZetrOZ Inc. (USA)
sam is the first and only FDA cleared multi-hour, daily use ultrasound therapy device. sam works by providing mechanical energy to injured tissues for targeted pain management, accelerated healing and enhanced tissue recovery.
Surgical Equipment, Instruments, and Supplies
NeuroBlate System, manufactured and submitted by Monteris Medical Corporation (USA)
The NeuroBlate System combines real time MRI and software-based visualization to allow surgeons to remotely ablate a wide variety of pathologies through the application of laser interstitial thermal therapy (LITT) and advanced robotics for precision, completeness, and confirmation of ablation.
HARMONIC FOCUS + Shears with Adaptive Tissue Technology, manufactured and submitted by Ethicon (USA)
HARMONIC FOCUS®+ Shears with Adaptive Tissue Technology are the only device surgeons need for fine dissection and sealing of vessels up to 5mm and lymphatics in open procedures. This can mean shorter procedures and better outcomes in the operating room.
Stryker PROFESS Navigation SystemTechnology, manufactured and submitted by Stryker Leibinger GmbH & Co. KG (Germany)
The PROFESS System is an intraoperative guidance system for use in intranasal and sinus surgery and allows the surgeon to observe the intraoperative location of surgical instruments relative to a CT image of the patient. The surgical instruments are tracked with video tracking technology using trackers with printed features and a low-cost video camera typically used in mobile devices.