The FDA’s first medical device cybersecurity chief says he will work across private and public lines to lower the threat of cyberattacks against medical devices and the healthcare systems and patients who use them. Medical device manufacturers can expect a new FDA cybersecurity draft guidance for new medical devices sometime this year, according to the […]
University of Michigan
FDA names first medtech cybersecurity chief
University of Michigan computer science researcher Kevin Fu has been named acting director of medical device cybersecurity at the FDA. Fu began working in the newly created 12-month post on Jan. 1, 2021, according to the university. His assignment is to bridge the gap between medicine and computer science and help manufacturers protect medical devices from digital […]
Who would — and wouldn’t — line up for COVID-19 vaccines?
Once enough people receive effective vaccines against the novel coronavirus, experts say, the end of the pandemic may be in sight. But a new poll of older adults — one of the highest-priority groups for vaccination — suggests an uphill climb lies ahead to reach that goal. In all, 58% of adults aged 50 to […]
Researchers develop speedy 3D printing
University of Michigan researchers said they have developed a 3D printing method that’s up to 100 times faster than conventional 3D printing processes. Rather than building up plastic filaments layer by layer, the new approach lifts complex shapes from a vat of liquid at high speed, potentially allowing manufacturers to produce up to 10,000 […]
Researchers develop nanodiscs to deliver personalized cancer therapy
Researchers from the University of Michigan have developed nanodiscs that deliver a customized therapeutic vaccine to treat colon and melanoma cancer in mice. The team’s work was published in Nature Materials. “We are basically educating the immune system with these nanodiscs so that immune cells can attack cancer cells in a personalized manner,” senior author James Moon said […]
University of Michigan sues St. Jude Medical for breach of contract
The University of Michigan is suing St. Jude Medical (NYSE:STJ), accusing the medical device maker of failing to pay $4.3 million in royalties on sales of St. Jude’s Epic and Trifecta cardiovascular valves.
Michigan U launches medical device wiki | MassDevice.com On Call
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.
FDA awards Michigan device makers $2.2 million to tune adult devices for pediatric use
The University of Michigan won a 2-year $2.2 million award from the FDA to support more than 40 ongoing projects aimed at developing medical devices for children.
"This award will give us a great opportunity to meet our vision of creating a long-term sustainable effort in pediatric device development under the umbrella of the U-M Medical Innovation Center," pediatric surgeon Dr. James Geiger said in prepared remarks. "We are humbled to receive this award."
University of Michigan gets $2.2 million FDA grant for pediatric devices
University of Michigan Pediatric Device Inventors Awarded Funds to Design Child-Specific Medical Devices
$2.2 million FDA grant designed to create safe solutions for medical problems in children
ANN ARBOR, Mich., Sept. 23, 2011 /PRNewswire-USNewswire/ — Adapting adult medical devices to be used for children is a common but often problematic practice across U.S. hospitals.
