Regulatory Approvals

Class II clearance expands the patient population that can be managed  Companies working with Huma's platform can now launch algorithm innovations more quickly in a...

The SI joint implant uses Nanotex surface technology to improve bone growth. SurGenTec has secured approval from the US Food and Drug Administration (FDA) for its TiLink-L...

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, announced that the Arrow® EZ-IO® Needle is the first and...

Radius VSM helps clinicians monitor various physiological measurements. Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its patient-worn, continuous multi-parameter vital...

Sparrow BioAcoustics  announced it has received clearance from the U.S. Food and Drug Administration to market its software that allows smartphones to be used...

Ezra, the healthcare AI startup transforming early cancer detection through full body MRI screening, announced that its newest proprietary Artificial Intelligence, Ezra Flash,...

THINK Surgical, Inc. recently announced that its TMINI™ Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). THINK Surgical...

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...