Hemolung RAS extracorporeal carbon dioxide removal system, manufactured and submitted by ALung Technologies Inc. (USA)
Hemolung RAS provides respiratory dialysis, a simple, minimally-invasive form of extracorporeal carbon dioxide removal (ECCO₂R) that acts as an alternative or supplement to mechanical ventilation in cases of acute respiratory failure.

ARKON anesthesia delivery system, manufactured by Spacelabs Healthcare (USA)
ARKON allows anesthesiologists to keep their patients in full view while simultaneously controlling and monitoring gas delivery using their preferred workflow. Entry submitted by and supply and design credit to Design Concepts Inc. (Madison, WI).

Isolibrium critical-care air support surface, manufactured and submitted by Stryker Medical (USA)
Isolibrium aims to provide tools for nurses to care for patients while its advanced pressure redistribution systems helps prevent pressure ulcers in patients. Supply and design credit to Humphrey Products company (Kalamazoo, MI), Grand Rapids Foam Technologies (Grand Rapids, MI), Les Produits Plastitel Inc. (Laval, Quebec, Canada), Twisthink (Holland, MI), and Derby (South Bend, IN).

Solea CO2 dental laser system for hard and soft tissue, manufactured by Convergent Dental Inc. (USA)
Entry submitted by HERNETICS (Chelsea, MA). At 9.3 μm, Solea is the first CO₂ laser system ever cleared by the FDA for hard and soft tissue ablation. Solea is fast, precise, virtually noiseless, and anesthesia-free for the vast majority of procedures. Supply and design credit to HERNETICS (Chelsea, MA), Tischler Resources (Acton, MA), and Sachem Engineering, R&D (Arlington, MA).

Digit Power dispenser for Aquasil Ultra Cordless tissue managing impression system, manufactured and submitted by Dentsply International, LD Caulk Division (USA)
The Digit Power dispenser enables dentists to precisely place Aquasil Ultra Cordless impression material directly into the sulcus. This system minimizes work time violiations and the use of retraction cord while providing significant time savings. Supply and design credit to Nordson EFD LLC (East Providence, RI), and Key Tech (Baltimore, MD).

Bluephase Style curing light featuring Polywave LED, manufactured and submitted by Ivoclar Vivadent AG (Schaan, Liechtenstein)
Bluephase Style is a cordless high-performance LED curing light that polymerizes all light-curing dental materials. Its ergonomic and compact design enables it to fit comfortably into the user’s hand. Supply and design credit to Rigami Design (Diepoldsau, Switzerland).

PROPEL and PROPEL mini mometasone furoate implants, manufactured and submitted by Intersect ENT (USA)
PROPEL and PROPEL mini dissolvable steroid-releasing implants reduce the need for additional surgical procedures and for oral steroids, which can have serious side effects, for patients suffering from chronic sinusitis.

DebioJect intradermal drug delivery device, manufactured and submitted by Debiotech SA (Lausanne, Switzerland)
The DebioJect was conceived to overcome the problems encountered with classical intradermal delivery techniques. The innovative microneedle allows both pain-free and precise injection of up to 500 μL in a few seconds. Supply and design credit to CEA-LETI (Grenoble, France), Mecaplast SA (Botterens, Switzerland), and the Royal Institute of Technology (KTH) (Stockholm, Sweden).

Auvi-Q epinephrine auto-injector, manufactured by Sanofi (USA)
Entry submitted by Kaléo Pharma (Richmond, VA). Auvi-Q is a single-use epinephrine autoinjector used to treat life-threatening allergic reactions (anaphylaxis). It is the size and shape of a credit card, the thickness of a cell phone, and includes a unique voice instruction system. Supply and design credit to Kaléo Pharma (Richmond, VA), and Medivative Technologies (Indianapolis, IN).

LuViva Advanced Cervical Scan point-of-care, non-invasive cervical disease detection device, manufactured by Guided Therapeutics Inc. (USA)
Entry submitted by Big Bang (Decatur, GA). LuViva is a test for early detection of disease that leads to cervical cancer. It does not require a tissue sample. The test provides an immediate and objective result at the point of care, reducing false-positive and false-negative results. Supply and design credit to Big Bang (Decatur, GA), Seaway Plastics Engineering (Port Richie, FL), Gupta Permold Corp. (Pittsburgh, PA), and Herman Miller Inc. (Zeeland, MI).

MetaNeb system, manufactured and submitted by Hill-Rom Services Pte. Ltd. (Singapore)
MetaNeb is indicated for mobilization of secretions, lung expansion therapy, and treatment and prevention of pulmonary atelectasis. It can also provide supplemental oxygen when used with compressed oxygen.

MuV patient transfer system, manufactured by CEGA Innovations LLC (USA)
The MuV system is lightweight and ergonomically designed to reduce patient stress and the physical toll on hospital workers during patient transfer, reducing workplace injuries and increasing efficiencies and reimbursement criteria. Entry submitted by and supply and design credit to Kablooe Design (Blaine, MN).

GUIDE DBS programming planning and visualization system for deep brain stimulation (DBS), manufactured and submitted by Boston Scientific Corp. (USA)
GUIDE DBS is a software program that creates a 3-D image of a patient’s deep brain anatomy and the relative location of the implanted lead. A model of the volume of activated tissue allows the clinician to intelligently optimize stimulation parameters.

Eclipse soft tissue anchor, manufactured and submitted by MedShape Inc. (USA)
The Eclipse offers an innovative, nonrotational approach for reattaching soft tissue to bone. It features an expandable sheath-and-bullet design that preserves tissue orientation while reducing surgical complexity and increasing confidence in the repair. Supply and design credit to Enginuity Works (Atlanta, GA), and Creature LLC (Atlanta, GA).

Codacs direct acoustic cochlear implant system, manufactured and submitted by Cochlear Ltd. (Sydney, Australia)
The Codacs system meets an unmet patient need by mechanically stimulating the cochlea, bypassing the impaired middle and outer ear of people with severe to profound mixed hearing loss. Supply and design credit to Helbling Technik (Liebefeld, Switzerland).

AtomoRapid HIV (1&2) integrated rapid antibody test, manufactured and submitted by Atomo Diagnostics Pty Ltd. (Sydney, Australia)
AtomoRapid HIV is the first integrated rapid test for detection of HIV 1&2 using blood. It replaces the need for existing test kits with multiple items that are complicated to use, thus reducing the inherent error rates found when using kits in the field. Supply and design credit to IDE Group Inc.(Newington, Australia).

NIOX VERO airway inflammation monitor, manufactured by Aerocrine AB (Solna, Sweden)
Entry submitted by Veryday (Bromma, Sweden). NIOX VERO enables clinical monitoring of airway inflammation and plays a critical role in the efficiency of diagnosis, treatment, and follow-up of patients with inflammatory airway diseases, such as asthma. Supply and design credit to Veryday (Bromma, Sweden), Panasonic Healthcare Co. Ltd (Tokyo, Japan), and IT Dr. Gambert GmbH Wismar (Wismar, Germany).

HYBRiD-XL fully automated continuous access analyzer, manufactured by DRG Diagnostics GmbH (Marburg, Germany)
The DRG:HYBRiD-XL allows, for the first time, simultaneous measurement of immunoassays and clinical chemistry parameters including turbidimetric tests in one sample. Entry submitted by and supply and design credit to BIT Group (San Diego, CA).

SoTube SoSafe double-sterile barrier packaging, manufactured and submitted by Selenium Medical (La Rochelle, France)
SoTube/SoSafe are two innovative solutions, nested tubes based, for implants double-sterile barrier packaging. They ensure nurses and surgeons easy handling of package and implant as well as a pioneer “No Touch” approach right up to the point of surgery.

Safe Label System (SLS) enterprise-wide electronic medication preparation safety system, manufactured and submitted by Codonics Inc. (USA)
SLS is an on-demand medication preparation-specific system that replicates pharmacy oversight at the point of care. It ensures TJC compliance with best practices and standards to improve patient safety, workflow efficiency, accuracy, and reduce drug errors. Supply and design credit to SIMS Lab and Partner’s Healthcare at Massachusetts General Hospital (Boston, MA).

DISK (Dispenser Integrated System Kit), manufactured and submitted by CleanCut Technologies LLC (USA)
DISK is thermally bonded to an HDPE backer card and is intended to provide medical device product retention and protection during packaging, handling, sterilization, shipping, and use in medical environments.

AEROBIKA oscillating positive expiratory pressure therapy system, manufactured and submitted by Trudell Medical International (London, Canada)
The AEROBIKA oscillating PEP device helps loosen and remove mucus build-up in the lungs. On exhalation, positive pressure holds the airways open, while oscillations thin and loosen mucus helping move it to the central airways where it can be coughed out. Supply credit to Silcotech (Bolton, Canada), and C&J Industries Inc. (Meadville, PA).

Tria Age-Defying Laser handheld dermatological device, manufactured by Tria Beauty Inc. (USA)
Tria Age-Defying Laser lets consumers achieve professional anti-aging results at home. The safe, effective skincare device uses fractional laser technology to smooth wrinkles, reduce discoloration, and improve the texture of all skin types. Entry submitted by and supply and design credit to IDEO (Palo Alto, CA).

FreeStyle Optium Neo blood glucose and ketone monitoring system (not available for sale in the United States), manufactured and submitted by Abbott Diabetes Care Inc. (USA)
FreeStyle Optium Neo guides patients through their diabetes and insulin management. Set up by a healthcare provider, the meter stores, displays, logs, and suggests insulin dose adjustments. It also notifies of high or low blood glucose levels and trends. Supply and design credit to Bridge Design (San Francisco, CA).

AIRO Mobile Computed Tomography (CT) System, manufactured and submitted by Mobius Imaging LLC (USA)
The AIRO Mobile CT integrates advanced imaging technologies into existing medical workflow and provides the clinician with procedural flexibility as well as real-time CT imaging information where and when it is needed. Supply and design credit to Varian Medical Systems (Salt Lake City, UT), Excelitas Technologies (Salem, MA), Hamamatsu Corp. (Bridgewater, NJ), Analog Devices Inc. (Norwood, MA), Rotek Inc. (Aurora, OH), Marlborough Foundry Inc. (Marlborough, MA), and Aved Electronics Inc. (North Billerica, MA).

NvisionVLE Imaging System, manufactured by NinePoint Medical (USA)
The NvisionVLE Imaging System is the first and only volumetric optical coherence tomography device cleared by FDA for endoscopic imaging and imaging of esophageal tissue microstructure. Entry submitted by and supply and design credit to Farm Design Inc. (Hollis, NH).

LumaGEM Molecular Breast Imaging (MBI) system, manufactured and submitted by Gamma Medica (USA)
LumaGEM is an effective adjunct to standard mammography. It is a patient-friendly and cost-effective tool for detecting early-stage cancers in dense breast tissue. Supply and design credit to Farm Design Inc. (Hollis, NH), and Sunrise Labs (Auburn, NH).

Vector Gait and Safety System, manufactured and submitted by Bioness Inc. (USA)
The Vector Gait and Safety System is a ceiling-mounted robotic technology designed to improve patient mobility and functional independence by tracking movement and offloading a precise amount of body weight during rehabilitation. Supply and design credit to D&K Engineering (San Diego, CA).

Carevo shower trolley, manufactured by ArjoHuntleigh Innovation Center (Malmö, Sweden)
The Carevo is a modern shower trolley for therapeutic showering and bathing. It offers comfort and dignity to patients during daily hygiene care and enables caregivers to work close to patients, reducing static stress. Entry submitted by and supply and design credit to Veryday (Bromma, Sweden).

Hercules Patient Repositioner, manufactured and submitted by The Morel Company (USA)
The Hercules allows a single caregiver to safely reposition a patient up in bed in less than ten seconds with the simple push of a button.

Zip Surgical Skin Closure, manufactured and submitted by ZipLine Medical Inc. (USA)
Zip is a noninvasive skin closure alternative to sutures and staples for surgery and lacerations, offering time-savings, better cosmesis, lower infection risk, and greater patient comfort. It is easy to apply and patients can remove it at home. Supply and design credit to Innovative Drive LLC (Redwood City, CA).

INTUITION Instruments for DePuy ATTUNE Knee System, manufactured by DePuy Synthes, Joint Reconstruction (Leeds, UK)
INTUITION instruments combine the surgical process with the implant options to allow surgeons to balance the soft tissue as well as control the implant position and fit for each patient. Entry submitted by and supply and design credit to DePuy Synthes, Joint Reconstruction (Warsaw, IN).

INTUITION Instruments for DePuy ATTUNE Knee System, manufactured by DePuy Synthes, Joint Reconstruction (Leeds, UK)
INTUITION instruments combine the surgical process with the implant options to allow surgeons to balance the soft tissue as well as control the implant position and fit for each patient. Entry submitted by and supply and design credit to DePuy Synthes, Joint Reconstruction (Warsaw, IN).

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