FDAnews Device Daily Bulletin

A new Medicare Physician Fee Schedule requirement that doctors document an in-person encounter with beneficiaries before being reimbursed for durable medical equipment (DME) they provide has some in the industry worried that suppliers may not be paid.

A federal judge has ordered the FDA to release additional pages of logs and documents concerning its surveillance of six current and former employees who reported device safety concerns to Congress and the U.S. Office of Special Counsel.

Medical device recruiters most likely will be taking note of Proteus Digital Health after the California-based company announced that federal officials have cleared its innovative new ingestible sensor, which could be a game changer in the healthcare management industry.

Aethlon Medical reported today that the two most recent hepatitis C infected patients to receive Hemopurifier therapy in combination with peginterferon+ribavirin drug therapy achieved undetectable viral load at day seven.

A Pennsylvania medical device company is moving its distribution operations to Olive Branch, Miss., creating about 225 jobs within four years.

Medical devicemaker Covidien touted FDA clearance for the latest in its line of Nellcor patient monitors, the Bedside SpO2.

Natick, Mass.-based medical devicemaker Boston Scientific has announced the advancement of its Ingenio and Advantio pacemakers in Europe.

SafeStitch Medical announced they have entered in a distribution agreement with Herniamesh, an Italian mesh manufacturer operating in the biomedical market, to distribute mesh used for inguinal and ventral hernia repair in the United States.