The Medical Device Business Journal — Medical Device News & Articles | MassDevice
MASSDEVICE ON CALL — The U.S. Dept. of Health & Human Services and 2 other federal agencies may have blown some $321 million on IT systems that were already in place, according to a Government Accounting Office report.
The GAO identified 12 "potentially duplicative" investments at HHS, the Dept. of Homeland Security and the Defense Dept., out of the 590 it reviewed.
By Stewart Eisenhart, Emergo Group
The US Government Accountability Office (GAO) has issued recommendations that the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies.
Medical device companies under increasing pressure to bolster cybersecurity measures warned that heightened security comes at a cost.
Adding new layers of security into devices like pacemakers and insulin pumps, which have proven hack-able in recent years, may require compromises in features like battery life, device makers told the Government Accountability Office.
The FDA needs to step up its information security review standards to identify, monitor and address the threat of malicious medical device hacking, according to a newly released report from the Government Accountability Office.
A handful of government bodies are asking federal regulators to establish medical device software security protocols as part of the FDA’s regular review of medical devices.
The U.S. Dept. of Homeland Security joined the Information Security & Privacy Advisory Board of the National Institute of Standards & Technology in calling for heightened review of medical devices, citing security weaknesses that may leave them vulnerable to "malicious tampering."
MASSDEVICE ON CALL — A team of University of Michigan students built an online compendium of innovative medical devices "designed for use and/or implemented within resource-limited settings."
The database, intended for health care providers in developing countries, already contains more than 100 devices, including a pedal-powered nebulizer, wax-filled sleeping bags for warming infants and a salad-spinner centrifuge for blood samples.
Happy 3rd birthday, MassDevice!
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.
"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."
