FDAnews Device Daily Bulletin

The outlook for companies making implantable cardiac defibrillators (ICDs) may have just gotten a bit brighter, as the U.S. Department of Justice (DoJ) took a significant step toward closing out its investigation of off-label use of ICDs in U.S. hospitals.

A newly released draft guideline on clinical trial death and injury compensation in India has clinical researchers concerned about how the basis for claims will be decided and payments formulated.

The $610 million deal between the FDA and the medical device industry is in jeopardy as Congress dithers over the federal watchdog agency's budget, meaning that product reviews for devices and drugs could slow or even grind to a halt.

The Ninth Circuit on Monday vacated a California federal jury’s $60 million verdict against NuVasive on claims it violated Neurovision Medical Products’ medical device trademark, saying the lower court misled the jury and improperly excluded evidence.

Danvers cardiac device maker Abiomed has won federal approval to sell a new heart pump that is less invasive and delivers greater blood flow than a similar model it now markets.

Bio DG announced today that its patent for a novel metal system for use as biodegradable material in developing implantable medical devices was granted by the U.S. Patent and Trademark Office on Aug. 21.

Intact Vascular announced the completion of a $15.5 million Series A round. Series A financing is the first round of financing undergone for a new business venture after seed capital, where company ownership is often offered to external investors.

Polycom announced the Polycom RealPresence Practitioner Cart 8000, a new telemedicine cart which connects live with patients and on-site caregivers via secure high-definition video and audio to allow medical professionals to have remote consultations with patients, even if those patients are located far away from a major medical center.