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The test “can potentially eliminate the need for time-consuming and expensive PET scans,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. Read More
Patients whose feeding tubes were placed using Baltimore, Md.-based CoapTech’s PUMA-G bedside ultrasound imaging system had shorter hospital stays, according to researchers at the University of Maryland’s medical center. Read More
Adaptiiv Medical Technologies, a medical device software developer based in Halifax, Nova Scotia, has partnered with the 3D printing giant HP and the radiation oncology firm Varian to offer customized 3D printed devices for use in radiation treatments. Read More
Under FDA medical device regulations, all products must be fully verified, generally by postproduction test or inspection, to ensure that they meet each of their design specifications. The agency defines a product as anything created by a process, including individual components of a device, materials involved in manufacturing the device — whether or not those materials are a part of the finished device — and even the in-process device itself. Read More
Congress is aiming to hold the device industry’s feet to the fire on cybersecurity by proposing new requirements in the fifth reauthorization of the Medical Device User Fee Act (MDUFA V). Read More
An artificial intelligence (AI) algorithm developed at the Mayo Clinic in Rochester, Minn., used data from the Apple Watch to identify patients with a weak heart pump, providing results similar to that of a medical treadmill test, according to the researchers. Read More
Preliminary research showed that the Mirvie RNA platform can identify 75 percent of women who go on to develop preeclampsia, months before symptoms occur. Read More