Indianapolis Helmet Maker Warned on Records, Procedural Flaws
The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.
Physicians Could See More Medical Devices Going Mobile
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.
AirStrip Acquires Palomar Tech to Enable Mobile EHR Access
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…
Mazor Robotics Received KFDA Approval for Renaissance System
MAZOR Surgical Robotics announced that it has received Korean Food and Drug Administration (KFDA) approval for its Renaissance System, a new generation surgical robot.
MIT Engineers Develop New Glucose-Powered Implantable Medical Device
MIT engineers have developed a fuel cell that runs on the same sugar that powers human cells: glucose.
GHTF Updates Definition of Medical Device, Adds Definitions for IVD, Device Accessory
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…
House Subcommittee Sets Lower CDRH Funding for Fiscal 2013
The House Appropriations Committee subcommittee that oversees FDA funding recommends fiscal 2013 appropriations that would slightly reduce agency spending. A full committee markup of the bill, as yet unnumbered, hasn’t…