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Diagnostics & Healthcare News
FDA clears Signifier Medical’s Electric Tongue Muscle Strengthener to Treat Sleep Apnea and Snoring
The FDA has approved eXciteOSA, the revolutionary first-ever daytime treatment for mild obstructive sleep apnea and snoring. Used for only 20 minutes per day for a period of six weeks and then twice per week, the therapy is clinically proven...
February 21, 2021
Cardiovascular / Cardiology
Implicity Rolls Out AI-Empowered Remote Cardiac Monitoring to Over 10,000 Patients
Implicity, the leading remote cardiac monitoring company in Europe, officially announced its rollout into the US market via its partnership with the Phoenix-based company, IronRod Health. Implicity and IronRod have been nominated for The Prix Galien Medstartup USA in the...
February 21, 2021
Cardiovascular / Cardiology
Vascular Perfusion Solutions Lands FDA Breakthrough Designation for Organ-Transport Device
The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device Designation for its groundbreaking VP.S Encore™ oxygenated perfusion cardiac transport device. The patent-pending technology uses oxygen to enable preserving vascularized tissue for eight...
February 14, 2021
Cardiovascular / Cardiology
Puzzle Medical Receives FDA Breakthrough Device Designation for Transcatheter Heart Pump
Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. The FDA Breakthrough Device Program is intended to...
February 14, 2021
Orthopedics and Spine
Acuitive Technologies Wins FDAClearance for Tendon Interference Screw System
Acuitive Technologies announced last week that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITREFIX™ Knotless Suture Anchor System with CITREGEN™ material technology, a new generation bioresorbable synthetic polymer. The CITREFIX system...
February 14, 2021
Diagnostics & Healthcare News
CLEW Medical Receives FDA Clearance for AI-Based Software that Predicts Hemodynamic Instability
CLEW Medical, a leader in AI-powered predictive analytics, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance and authorized the use of “CLEWICU,” CLEW’s artificial intelligence (AI) based ICU solution, to predict hemodynamic instability in...
February 7, 2021
Diagnostics & Healthcare News
Inovytec’s Small “Sparrow” Ventilators Receive FDA Clearance
Inovytec, an innovator of multi-functional and user-friendly critical medical devices, announced today that it was granted FDA 510(k) clearance to market and sell its Ventway Sparrow ventilators in the United States. The ventilators are already commercialized in Europe, Canada and Australia and undergoing registration procedures...
February 7, 2021
Orthopedics and Spine
Zimmer Biomet Spinning Off Spine & Dental Business
Zimmer Biomet (Formerly Known As Biomet Inc.) Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced its intention to spin off the Company’s Spine and Dental businesses to form a new and independent, publicly traded company...
February 7, 2021
Imaging Visualization & Navigation
ZAP Surgical Receives CE Mark Clearance for its ZAP-X Gyroscopic Radiosurgery Platform
ZAP Surgical Systems, Inc. today announced it has received CE mark clearance to the new EU MDR for its ZAP-X® Gyroscopic Radiosurgery® platform. The CE mark makes it possible for healthcare providers to begin treating patients with the ZAP-X system...
February 7, 2021
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