Regulatory Approvals

Galen Robotics, Inc., a leading medtech company specializing in advanced robotic surgical systems, today announced U.S. Food and Drug Administration (FDA) De Novo classification...

HoneyNaps has received approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI) sleep disease analysis algorithm, SOMNUM. The new software surpasses conventional...

Tyber Medical has secured approval from the US Food and Drug Administration (FDA) and European Union Medical Device Regulation (EU MDR) for its implantable K-Wires and...

The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain...

Natural Cycles, the company that developed the world’s first birth control app, today announced it has received 510(k) clearance from the U.S. Food and...

The FDA has granted 510(k) clearance and breakthrough device designation to the company’s obstructive hydrocephalus CT scan software. Annalise.ai’s portfolio of artificial intelligence (AI)-powered triage...

Insight Medbotics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its magnetic resonance imaging (MRI)-compatible robot, the IGAR system. The clearance enables...

The US Food and Drug Administration (FDA) has approved CorVista Health’s non-invasive medical device system with a CAD Add-On option for detecting the presence of...

The U.S. Food and Drug Administration announced Sep 6 that it is hoping to modernize the premarket notification 510(k) program that many radiology devices...