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.
LivaNova (NASDAQ: LIVN)+
says it’s the latest victim of a cybersecurity incident.
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 announced today that it launched a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM.
The company received approval for the hypertension treatment despite a mixed vote from an FDA advisory panel.
Catheter Precision’s (VTAK) First Successful VIVO(TM) Cases Completed in Croatia Sets Stage for Expansion into South-Eastern Europe
FORT MILL, SC / ACCESSWIRE / November 20, 2023 / Catheter Precision, Inc. (the “Company”) (NYSE American:VTAK), a pioneering medical technology firm headquartered in the United States, specializing in electrophysiology devices, has proudly disclosed the successful conclusion of the inaugural VIVO cases in the region of South-Eastern Europe. VIVO, the Company’s innovative 3D non-invasive imaging system, is used pre-procedurally to identify areas of interest for ventricular ablation and aid in pre-procedure planning to reduce procedure time and aid in procedural accuracy.
Medtronic (NYSE: MDT)+
said today that it’s received a CE mark for its PulseSelect pulsed field ablation system.
The new sensor measures heart and breathing rate from patients with sleep apnea and could also be used to monitor people at risk of opioid overdose.