Regulatory Approvals

Radiaction Medical, Ltd. ("Radiaction"), a medical device innovator dedicated to providing healthcare physicians and staff with effective radiation protection during interventional procedures, announced it...

The FDA clearance will enable NeuroOne to market its Evo sEEG System for temporary use of less than 30 days. The US Food and Drug...

As against current MIS technologies, the TELIGEN System could be efficient and cost-effective for hospitals. The US Food and Drug Administration (FDA) has granted 510(k) clearance for DePuy...

The neurostimulation device, which is currently for investigational use only, aims to treat cognitive and functional decline in Alzheimer's patients. Cambridge-based Sinaptica Therapeutics, a company...

Hugo is going on a whirlwind international tour. Medtronic’s modular surgical robot has received a series of new regulatory approvals the company says will greatly expand...

Abiomed (Nasdaq:ABMD) announced that it received FDA 510(k) clearance for its Impella low-profile sheath. Danvers, Massachusetts-based Abiomed designed its sheath to maintain the same inner...

The Flux-C 3D porous titanium devices are available in several parallel and lordotic options with different heights. ulrich medical USA has secured 510(k) clearance from the US...

XACT Robotics® has announced that its ACE Xtend™ Remote Control Unit received U.S. Food and Drug Administration (FDA) clearance, allowing users to robotically insert and...

Next Generation Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief Using Each Patient's...