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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
MIVI Neuroscience received a Form 483 with three observations for inadequate corrective and preventive action (CAPA) activities and documentation issues observed during an FDA inspection of the company’s facility in Eden Prairie, Minn., last December. Read More
Companies that market in vitro diagnostic devices (IVDs) in the EU may continue to use existing certificates after the EU’s new In Vitro Diagnostics Regulation (IVDR) goes into effect on May 26 as long as they do not make “significant” changes to the products’ design or intended purposes. Read More
The FDA on Friday issued a draft guidance on its Voluntary Improvement Program (VIP), which uses third-party quality appraisals to help manufacturers improve their production and quality practices, signaling VIP’s transition from a pilot to a permanent program. Read More