Regulatory Approvals

Artiria Medical, a Swiss neurovascular MedTech company, announces that its real-time deflectable guidewire has been granted the 510(k) clearance by the U.S. Food and...

The company's iPredict System allows providers to detect age-related macular degeneration in the clinical setting. iHealthScreen, maker of AI-enabled software for retinal imaging, received FDA...

U.K. medtech startup Acurable has gained FDA clearance for a novel wireless diagnostic device for remote detection of obstructive sleep apnea (OSA). A formal launch into...

First and only, automated insulin-delivery system that determines 100% of all insulin doses. - No carb counting*, no corrections, no calculating boluses. - Only...

Abbott's Assert-IQ offers the world's longest battery life† for an insertable cardiac monitor (ICM) The latest addition to Abbott's portfolio of connected health devices, the...

inHEART solution creates digital 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize cardiac ablation procedures Cambridge, MA...

A medical device that aims to make administration of epidurals more reliable and safer has been cleared by the FDA, giving its developer Omeq...

It’s meant to enhance Samsung’s existing EKG features and arrives later this year with One UI 5 Watch. Samsung announced today that it received clearance from the...

 Omeq Medical Ltd. a portfolio company of The Trendlines Group Ltd., announced that it has received regulatory clearance from the United States Food and Drug...