Regulatory Approvals

US FDA grants pre-market approval for Abiomed’s Impella RP Flex

The Impella RP Flex is indicated to provide temporary right ventricular support for up to 14 days. The US Food and Drug Administration (FDA) has granted pre-market...

Radiaction Medical Announces the Latest Food and Drug Administration 510(k) Clearance for its Novel, Automated Radiation Shield System, Highlighting U.S. Expansion

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

FDA grants 510(k) clearance for NeuroOne’s Evo sEEG Electrode technology

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...

FDA grants 510(k) clearance for DePuy Synthes’ TELIGEN System

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...

Sinaptica Therapeutics obtains FDA Breakthrough Device Designation for Alzheimer’s treatment

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...

Medtronic’s Hugo surgical robot collects green lights in Europe, Canada, Japan

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...

FDA clears Impella low-profile sheath from Abiomed

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...

ulrich medical’s cervical interbody device secures FDA 510(k) clearance

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® Wins FDA Clearance for ACE Xtend™ Remote Control Unit

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...
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