FDAnews Device Daily Bulletin

An Oct. 1 CDRH reorganization brings radiological and mammography devices and in vitro diagnostics under a new Office of In Vitro Diagnostics and Radiological Health.

Contact lens manufacturers should tie risk assessments to the shelf life of their products to ensure they don’t deteriorate during storage and are safe and effective when used, a revised International Organization for Standardization (ISO) standard advises.

A new report by the Center on Budget and Policy Priorities claims that the 2.3 percent medical device excise tax set to go into effect at the end of the year will not have a negative impact on thousands of medical equipment sales jobs.

St. Jude Medical announced the launch of its MediGuide Technology, the first and only 3-D navigation system intended for the evaluation of vascular and cardiac anatomy on a recorded fluoroscopic image instead of live fluoroscopy.

The Greater Fort Lauderdale Alliance announced two new companies creating jobs in Broward County, Florida, at its recent annual meeting.

The CEO of an Israeli manufacturer of medical devices that help paraplegics to walk said he is excited to establish the company’s U.S headquarters in Marlborough, Mass.

With a focus on developing lesion-specific solutions for peripheral artery disease, Medtronic announced the U.S. and international launches of the Amphirion Plus Percutaneous Transluminal Angioplasty Catheter for the interventional treatment of atherosclerotically narrowed or occluded leg arteries below the knee.

Physicists have developed a technique to sterilize medical devices and prostheses using jets of “cold” plasma.