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Customers who don’t have access to an appropriate sterilization method should stop using the devices and return them to the manufacturer, the FDA said. Read More
MedTech Europe is adopting a revised ethics code that says collaborative research projects between devicemakers and nonindustry partners must “be for the benefit of patients or benefit the healthcare organization (HCO) and at least maintain patient care.” Read More
Durham, N.C.-based Bioventus is buying CartiHeal and its Agili-C implant for knee-joint cartilage surface lesions, a breakthrough device which recently received the FDA’s premarket approval. Read More
Noting the scarcity of effective COVID-19 home tests, bioLytical Laboratories said it will deliver to customers “a reliable home test from a local manufacturer they can trust.” Read More
The device reduces radiation by more than 90 percent, protecting all personnel in the room against the high levels of scattered radiation generated by the X-ray equipment, the company said. Read More
Information about leveraging validation data to support COVID-19 test approvals has now been added to the FDA’s COVID-19 Test Development and Review FAQ page. Read More
Several advocacy groups have written to the House Energy and Commerce Committee and its Subcommittee on Health to defend the “right to repair” devices and push back against what they view as moves to restrict it. Read More