A US FDA final guidance on hysteroscopically placed tubal implant permanent sterilization devices calls for a "black box" warning, pointing out perforation, pain, allergic reactions and other potential adverse events uncovered for Bayer's Essure device. It emphasizes the importance for physicians to employ a patient-decision checklist with the products.
A final FDA guidance on Bayer HealthCare LLC's Essure permanent female sterilization device warns that"some women are not receiving or understanding information regarding the risks" of the hysteroscopically placed tubal implants, and formally calls for a "black box" warning listing adverse events associated with the product.
Essure has been the subject of more than 5,000 adverse events reports to FDA from women who had the sterility...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.
With the reversal of the Chevron doctrine in June, lower courts will now have more say in deciding regulatory statutes when the language is murky. But will that open the door to more legal challenges from the healthcare industry against government regulations it finds unfavorable? A pair of legal experts recently discussed the potential implications of the Court’s decision.
The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
The Food and Drug Administration’s final guidance outlines the agency’s thinking for sponsors submitting de novo requests electronically, which they must starting in October 2025.
