The US Food and Drug Administration (FDA) has granted 510 (k) clearance for the expanded use of Onward Medical’s ARC-EX ...

The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation ...

Vesalio announced two FDA 510(k) clearances for its aspiration devices for peripheral and neurovascular applications, ...

An Upper Saucon Township company that specializes in surgical equipment will pay $38.5 million to settle allegations under ...

The FDA has cleared home use of a device that helps people with spinal cord injuries regain mobility and functioning.

Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...

Competing with companies including Stryker and J&J, Zimmer has moved to strengthen its position by developing an updated ...

Two Chicago-area medical device companies announced federal clearances for their respective spinal surgery devices.

The FDA has granted 501 (k) clearance to the EXENT® System, a fully automated device for assessing monoclonal gammopathies, ...

Brendan O'Callaghan, 37, from Armaghbrague Road in Tassagh, was sentenced to five and a half years, split between licence and prison.

Study reveals a gap FDA approval AI radiology devices with only 29% undergoing clinical testing before clearance.

Withings has long been a leader in connected health, but the company’s newly FDA-cleared BeamO may be its most innovative ...