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University of Michigan

New FDA medtech cybersecurity chief: Guidance to debut in 2021

February 19, 2021 By Nancy Crotti

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 Medical device manufacturers can expect a new FDA cybersecurity draft guidance for new medical devices sometime this year, according to the […]

Filed Under: Featured, Food & Drug Administration (FDA), Health Technology, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: Cybersecurity, FDA, University of Michigan

FDA names first medtech cybersecurity chief

February 3, 2021 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Cybersecurity, FDA, University of Michigan

Who would — and wouldn’t — line up for COVID-19 vaccines?

November 24, 2020 By Nancy Crotti

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 […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceutical, Research & Development Tagged With: AARP, BioNTech, coronavirus, COVID-19, Moderna, Pfizer, U.S. Centers for Disease Control and Prevention, UBS, University of Michigan, vaccines

Researchers develop speedy 3D printing

January 15, 2019 By Nancy Crotti

  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 […]

Filed Under: Research & Development Tagged With: University of Michigan

Researchers develop nanodiscs to deliver personalized cancer therapy

December 28, 2016 By Sarah Faulkner

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 […]

Filed Under: Drug-Device Combinations, Oncology, Pharmaceutical, Research & Development Tagged With: University of Michigan

University of Michigan sues St. Jude Medical for breach of contract

July 9, 2012 By MassDevice staff Leave a Comment

University of Michigan
MassDevice.com news

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.

Filed Under: Legal News, News Well Tagged With: Biomet, Clinipro, ConvaTec, Given Imaging, JP Morgan Chase, Legal Roundup, M*Modal, PhotoMedex Inc., Quattro Vascular, Smith & Nephew, stjudemedical, Tria Beauty Inc., TriReme Medical Inc., University of Michigan, Zeltiq

Michigan U launches medical device wiki | MassDevice.com On Call

April 27, 2012 By MassDevice staff Leave a Comment

MassDevice 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.

Filed Under: Healthcare Reform, News Well Tagged With: Government Accountability Office, Healthbox, Insurance, On Call, University of Michigan, VGo Communications

FDA awards Michigan device makers $2.2 million to tune adult devices for pediatric use

September 26, 2011 By MassDevice Leave a Comment

Pediatrics

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."

Filed Under: Food & Drug Administration (FDA), Funding Roundup, News Well, Pediatrics Tagged With: University of Michigan

University of Michigan gets $2.2 million FDA grant for pediatric devices

September 26, 2011 By MassDevice Leave a Comment

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.

Filed Under: Pediatrics Tagged With: University of Michigan

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