medical device guru

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

Imaging Visualization & Navigation

FDA Clears MULTIX Impact C Ceiling-Mounted DR System

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system. Economically priced,...

January 30, 2021

Diagnostics & Healthcare News

FDA Approves Boston Scientific’s Vercise Genus Deep Brain Simulation System

Boston Scientific Corporation has received U.S. Food and Drug Administration approval of its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System. The portfolio, approved for conditional use in a magnetic resonance imaging (MRI) environment, consists of a family of Bluetooth-enabled,...

January 30, 2021

Cardiovascular / Cardiology

Medtronic Wins FDA Approval for DiamondTemp Ablation System

Medtronic, the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive...

January 30, 2021