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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
The catheter can be an effective option for patients who could not previously be treated with intravascular shockwave therapy, according to one user. Read More
The FDA granted the implants its premarket approval based on the results of a pivotal, two-year investigational device exemption clinical study. Read More
German device manufacturer Fresenius Kabi is acquiring Massachusetts-based infusion system manufacturer Ivenix in a purchase deal that includes $240 million upfront and future milestone payments. Read More