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Apples plans to release updates this fall for the Apple Watch and iPhone that will focus on 17 areas of health and fitness including heart health, sleep, mobility and women’s health. In a new report, the company also said it commits to working with the medical community to support research and care. Read More
The FDA’s draft guidance on cybersecurity for devices is a good start but needs some clarification, according to a working group of the International Organization for Standardization (ISO) and a variety of devicemakers. Read More
Germany’s Federal Institute for Drugs and Medical Devices released a notice showing that multiple Medtronic heart devices are being recalled in Europe due to reduced shock energy. Read More
Reliability is an important concept in medical device regulation. The FDA’s device regulation at 21 CFR 820.3(b) defines a complaint as an allegation of a deficiency in one or more of a long list of attributes, including reliability. And 860.7(b)(4), which specifies how device class and product codes are determined, includes reliability as a relevant factor in device classification. But the agency never defines the term within device regulations. Read More
Craftmatic Industries received a Form 483 for repeated problems with product quality and complaint-reporting issues observed in an FDA inspection of its Pompano Beach, Fla., facility earlier this year. Read More
Roche Diagnostics announced the launch of its Elecsys HCV Duo assay that simultaneously detects hepatitis C virus (HCV) antigens and antibodies from a single blood sample — the first commercially available test of its kind. Read More
In the absence of a fully functional Eudamed database, the EU’s Medical Device Coordination Group (MDCG) says diagnostics companies should continue to follow individual national regulations for regulatory filings and other actions until the portal comes fully online in two years. Read More