Posts by cstephenson@legacymedsearch.com
Medcura Receives Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat
Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S. Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat. LifeGel™ is the first and only hemostatic agent to receive Breakthrough Device Designation seeking a new and highly…
Read MoreMicronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection
Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). As a result, Micronoma can expect continued guidance and prioritized reviews from the agency of its upcoming clinical trial and concomitant pre-market approval…
Read MoreVERO Biotech Receives FDA Approval of its Third Generation Tankless Inhaled Nitric Oxide Delivery System
VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. The Third Generation GENOSYL® Delivery System – developed for respiratory therapists by respiratory therapists – has new features that are expected to deliver three key benefits…
Read MoreLydus Medical Announces FDA Clearance of Vesseal™, The Microvascular Anastomosis Aid Device for Small Arteries
Lydus Medical is pleased to announce that the Vesseal™ has received FDA clearance 510(k). The Vesseal™ is a microvascular anastomosis suture deployment system, for standardized omni-vessel anastomoses, enabling simple, fast, safe, and effective procedures. An anastomosis is one of the most complicated steps of microvascular surgery and fundamental to the success of these demanding surgical interventions. Varied clinical…
Read MoreABM Respiratory Care Announces the FDA Clearance of the Biwaze Clear System
ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the BiWaze® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung…
Read MoreImperative Care Announces FDA Clearance and Initial Cases of Zoom RDL, the First Stroke-Specific Radial Access Platform for Mechanical Thrombectomy
Imperative Care, Inc., announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ RDL Radial Access System, the company’s latest innovation in elevating stroke care and the first radial access platform developed specifically for ischemic stroke treatment. Zoom RDL is the newest addition to Imperative Care’s Zoom Stroke Solution™, the company’s ischemic stroke…
Read MoreBurning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test
Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally. Under the FDA’s Breakthrough…
Read MoreVisby Medical™ Receives FDA Emergency Use Authorization for Respiratory Health Test for use in CLIA waived settings
Visby Medical™ announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test. The Visby Medical Respiratory Health Test is a fast, polymerase chain reaction (PCR) device that detects and differentiates between upper respiratory infections caused by Influenza (Flu) A & B, and SARS-CoV-2 (COVID-19). Visby Medical has…
Read MoreEndoluxe Announces First ENT Procedures Using Endoluxe Vision System
Endoluxe congratulates Keith Matheny, MD, FARS, of Collin County Ear Nose & Throat in Frisco, TX, for being the first ear, nose and throat (ENT) surgeon in the U.S. to use the Endoluxe Vision System for endoscopic sinus surgery. Dr. Matheny is a nationally-known innovator in the field of Otolaryngology and has developed or been…
Read MoreInspira™ Technologies Begins Manufacturing of the ALICE™ CPB Device, ahead of planned 2023 FDA submission
Inspira Technologies OXY B.H.N. Ltd., a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. If FDA…
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