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Cardiovascular / Cardiology

Lydus 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...

January 9, 2023

Surgery and Surgical Robotics

ABM 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...

January 4, 2023

Cardiovascular / Cardiology

Imperative 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...

January 4, 2023

Diagnostics & Healthcare News

Burning 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...

January 3, 2023

Diagnostics & Healthcare News

Visby 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...

January 3, 2023

Surgery and Surgical Robotics

Endoluxe 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....

December 22, 2022

Cardiovascular / Cardiology

Inspira™ 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...

December 21, 2022

Orthopedics and Spine

Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for Limiflex™ Dynamic Sagittal Tether™

Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug Administration (FDA) submission process for the LimiFlex™ Dynamic Sagittal Tether™ (DST). The Premarket Approval (PMA) submission included...

December 20, 2022

Uncategorized

Sonorous NV Uses New Device to Treat Patients with Symptomatic Cerebral Venous Diseases

Sonorous NV, Inc. Chairman, Dave Ferrera, announced treatment of the first patients in North America with the BossStent® device designed to treat patients with symptomatic cerebral venous diseases. The single-use, implantable device acts as an endoluminal prothesis that is placed into a cerebral venous...

December 19, 2022