medical device guru

Cardiovascular / Cardiology

Recor Medical and Otsuka Medical Devices Announce Positive Vote from the FDA Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application...

August 23, 2023

Surgery and Surgical Robotics

Levita® Magnetics Wins FDA Clearance for Pioneering MARS™ System

Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its MARS™ platform. The Levita MARS system is a first-of-its-kind minimally invasive surgical...

August 22, 2023

Orthopedics and Spine

Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene

Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced 510(k) clearance from the U.S. Food and Drug Administration for its new, advanced Activit-E™ polyethylene for the Truliant® knee replacement system. “After years...

August 21, 2023

Diagnostics & Healthcare News

InBody Hits Milestone: 100 Million Tests Recorded Globally on Their LookinBody Web Platform

Highlighting a growing interest in body composition data, InBody is celebrating a long-anticipated milestone: 100 million tests taken globally on their body composition analyzers as of Friday, Aug. 4. “We’ve come a long way since InBody’s founding in 1996,” said...

August 18, 2023

Diagnostics & Healthcare News

Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®. This clearance reinforces Welldoc’s position as a leader...

August 17, 2023

Diagnostics & Healthcare News

Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication

Ceribell, Inc.® announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent...

August 16, 2023

Orthopedics and Spine

Viseon Inc. Announces Commercial Rollout and Initial Clinical Use of the 4K MaxView® System for Advanced Digital Visualization During Minimally Invasive Spine Surgery

Viseon Inc. announced the US commercial rollout and initial clinical use of the First-of-its-Kind 4K Advanced Visualization System for Minimally Invasive Spine Surgery. The Viseon MaxView 4K System is an enabling, towerless, state-of-the-art, advanced visualization system involving no capital equipment...

August 15, 2023

Biologics, Wound Care, Infection Prevention

Kerecis to Donate FDA-Approved Fish Skin for Burn Victims of Maui Wildfires

Kerecis®, the company pioneering the use of fish skin and fatty acids for tissue regeneration and protection, is donating its GraftGuide® fish-skin burn product for victims of the fires on Maui, Hawaii. Qualified medical personnel wanting to get fish-skin burn-treatment products...

August 14, 2023

Cardiovascular / Cardiology

Acorai receives Breakthrough Device Designation for their Non-Invasive Intracardiac Pressure Monitor

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai’s Heart Monitor, a device for the non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary...

August 10, 2023