The clearance positions the company to offer an alternative to continuous positive airway pressure devices and neurostimulation implants.
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.
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.
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.
The company received approval for the hypertension treatment despite a mixed vote from an FDA advisory panel.
Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of
their own home.”
Lehi, Utah-based Owlet designed the system to enable caregivers to better care for babies at home through advanced digital technologies.
Recor Medical announced that the FDA approved its Paradise ultrasound renal denervation (RDN) system for treating hypertension.
Interventional Systems announced that the FDA granted a new 510(k) clearance for its Micromate surgical robot system.
DePuy Synthes, the orthopedic device business of Johnson & Johnson (NYSE: JNJ)+
, has won FDA 510(k) clearance for its TriLeap lower extremity anatomic plating system.