Regulatory Approvals

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...

FDA accepts Sibel Health’s Aria sensor for COA qualification

Sibel Health has received acceptance from the US Food and Drug Administration (FDA) into the clinical outcome assessment (COA) qualification programme under the drug...

Synaptive Medical’s latest version of Modus Nav receives CE mark

Synaptive Medical is pleased to announce that its latest Modus Navigation System (Modus Nav) has achieved CE marking under the European Medical Device Regulation...

Breath Diagnostics receives FDA Breakthrough Device Designation for OneBreath platform

Breath Diagnostics, a leader in breath-based molecular diagnostics powered by patented microreactor capture technology, is pleased to announce that the U.S. Food and Drug...

Biomendex receives FDA 510(k) clearance for Adaptos Fuse Bone Graft

Biomendex announced that Adaptos® Fuse Bone Graft has received U.S. Food and Drug Administration (FDA) 510(k) clearance as a bone graft substitute for filling...
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