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Fdanewsdevicedailybulletin

Oct. 18, 2012

Vol. 9 No. 205

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IMDRF to Publish Audit Draft By End of Month: Regulator

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. Read More

Changes in South Korean Device Regulations Add New Hurdles

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. Read More

FDA Labels Accutron Recall Class I Over Nitrous Oxide Leak That May Harm Patients

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

Stryker Buys Surpass Medical for $135 Million

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. Read More

VBOX Trooper’s Oxygen Concentrator Soon Available in U.S.

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

Medtronic to Pay $66.2M for Stake in China Med Tech Company

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

Computer Viruses Are ‘Rampant’ on Medical Devices in Hospitals

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

Stryker Launches Revolutionary Computer Assisted Surgery Technology for Hip Fractures

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