MedTech News
US FDA Grants the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study
The EFS will evaluate the safety and feasibility of BTAH as a bridge to a heart transplant in the treatment of subjects with biventricular heart failure.
A new way to deliver drugs more efficiently
Core-shell structures made of hydrogel could enable more efficient uptake in the body.
RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva® Allograft Dermis in Breast Reconstruction
RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness of Cortiva® Allograft Dermis in implant-based breast reconstruction.
Smith & Nephew inks $180M CartiHeal buyout, capitalizing on Bioventus turmoil to land knee implant
Bioventus’ protracted buyout bid ultimately fell apart and opened the door to Smith & Nephew.
Another medtech company reports a cybersecurity incident
LivaNova (NASDAQ: LIVN)+
says it’s the latest victim of a cybersecurity incident.
Baird Medical Attains FDA Clearance to Market Its Microwave Ablation System in the United States
FRISCO, Texas, Nov. 21, 2023 /PRNewswire/ — Baird Medical Devices, Inc. (“Baird Medical” or the “Company”), a leading microwave ablation (“MWA”) medical device developer and provider in China, today announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received clearance from the U.S. Food and Drug Administration (the “FDA”) under Section 510 (K) to begin marketing its portfolio of Microwave Ablation Systems and Disposable Microwave Ablation Needles as regulatory Class II devices in the United States.
ViCentra launches hybrid closed-loop insulin system with Dexcom G6
ViCentra announced today that it launched a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM.
Medtronic receives FDA approval for renal denervation device
The company received approval for the hypertension treatment despite a mixed vote from an FDA advisory panel.