BioAccel, an organization dedicated to supporting earlystage medical device and technology entrepreneurs, is recruiting entrepreneur teams to compete in its premiere event, The Solutions Challenge…
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By Bakul Patel – As Yoda might say: build a case for interoperability, we must. While we may not have yet realized the technological accomplishments of Yoda’s advanced world, today connectivity shows great promise for the future. From blood pressure to brain scans, today’s health care allows for the rapid transfer and use of information between and among different medical devices.
By Matt Fisher – The annual OIG Work Plan was published on November 2nd. The Work Plan each year identifies what the Office of the Inspector General of the Department of Health and Human Services will review and provides insight into what the OIG contemplates as risk areas.
By Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., & Melinda K. Plaisier, M.S.W. – Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality.
By Nina L. Hunter PhD & Robert M. Califf MD – We recently announced the first FDA Patient Engagement Advisory Committee (PEAC), supported by the Center of Devices and Radiological Health (CDRH). The Committee will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients.
By Nina L. Hunter PhD & Robert M. Califf MD – Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important.
By Taha Kass-Hout, Roselie A. Bright & Ann Ferriter – OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research. OpenFDA’s Application Programming Interface (API) expands on the previous openFDA resources concerning medical device-related adverse events and recalls by incorporating information from the medical device product life cycle.
By John Halamka MD – Last week the U.S. Food and Drug Administration advised hospitals not to use Hospira’s Symbiq infusion system, concluding that a security vulnerability enables hackers to take remote control of the system. The agency issued the advisory some 10 days after the U.S. Department of Homeland Security warned of the vulnerability in the pump.
By Jonathon Dreyer – I’ll admit it: I’m a James Bond fan. And one of the things I love most is the obligatory scene in every film where Q does a run-down of all the gadgets with which Bond will be outfitted—including the upgrades to his always-impressive car.