Regulatory Approvals

Perfuze wins FDA clearance for standalone aspiration catheter

Perfuze announced that it received FDA 510(k) clearance for its Millipede88 aspiration catheter. Galway, Ireland-based Perfuze designed the catheter for rapid and complete clot removal...

Endo Tools Therapeutics receives FDA 510(k) clearance for EZFuse

Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for...

Prodeon gets FDA clearance for BPH-treating nitinol implant

Prodeon Medical announced that it received FDA 510(k) clearance for its Urocross expander system. Sunnyvale, California-based Prodeon designed Urocross as a novel, non-permanent implant technology...

KORU Medical Systems announces EU MDR Certification

KORU Medical Systems, a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions,...

Cairn Surgical announces FDA De Novo 510(k) submission for its BCL System

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced that it has submitted a De Novo...

OncoPatch wins FDA nod for tumor-treating patch device

OncoPatch announced that it received FDA 510(k) for its Oncopatch Surface brachytherapy system for treating localized tumors. The technology offers a distinct, patch-based approach to...

Airiver Medical wins FDA breakthrough nod for drug-coated balloon

Airiver Medical announced that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a...

Qure.ai nets six new indications cleared by the FDA

The US Food and Drug Administration (FDA) has given 510(k) class II clearance of qXR-Detect, the latest computer-assisted detection (CADe) radiography solution from global...

DeepHealth achieves CE Mark for TechLive

DeepHealth, Inc., a global leader in AI-powered health informatics and a wholly owned subsidiary of RadNet, Inc., announced that TechLive™, its FDA-cleared remote imaging...
1...345...113Page 4 of 113

Latest articles