FDAnews Device Daily Bulletin

The International Medical Device Regulators Forum (IMDRF) has approved a draft document outlining standards for international recognition of groups auditing devicemakers, an FDA official who attended the group’s recent meeting in Sydney, Australia, said.

New South Korean requirements for medical devices introduced this year make the country’s already strict regulation of foreign devicemakers even more rigorous, an expert says.

The FDA slapped Accutron’s recall of 206 flowmeters with Class I status, the agency’s designation for the most serious type of recall.

Devicemaker Stryker said it had reached a deal to buy privately held Surpass Medical for $100 million in cash, plus up to $35 million in milestone payments.

VBOX, a Minnesota-based company, was given FDA clearance to bring to market its portable oxygen concentrator.

Medtronic announced that it has agreed to buy a 26.4 percent stake in Shenzhen, China-based cardiovascular device maker LifeTech Scientific Corporation.

Computerized hospital equipment is increasingly vulnerable to malware infections, according to participants in a recent government panel.

Stryker Corporation announced today that it has launched a revolutionary computer-assisted surgery system, Stryker ADAPT, for the Gamma3 Locking Nail system.