FDAnews Device Daily Bulletin

The House Appropriations Committee subcommittee that oversees FDA funding recommends fiscal 2013 appropriations that would slightly reduce agency spending.

The Global Harmonization Task Force’s (GHTF) Study Group 1 has modified its definition of a medical device and provided an explicit definition for the term in vitro diagnostic (IVD) medical device, according to a final document released May 16.

The FDA has made important strides in improving its medical device review process, devices chief Jeffrey Shuren said this week.

MIT engineers have developed a fuel cell that runs on the same sugar that powers human cells: glucose.

MAZOR Surgical Robotics announced that it has received Korean Food and Drug Administration (KFDA) approval for its Renaissance System, a new generation surgical robot.

Masimo said Henry Schein Medical, the Medical business unit of Henry Schein, will distribute the new Pronto-7, a palm-sized hand-held device, designed for quick and easy spot-checking of total hemoglobin, SpO2, pulse rate and perfusion index.

This week San Antonio-based AirStrip Technologies announced that it was expanding its suite of mobile patient monitoring applications to enable physicians to more easily access information housed in various electronic health record systems via their mobile devices.

If all goes as the wireless health industry plans, it can start introducing far more products that allow physicians to monitor patients with no wires attached.