Enforcement & Litigation
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An import ban on Apple Watches has been put on hold as the US Patent and Trial and Appeal Board (PTAB) reviews AliveCor’s patent appeal.
Medtech trade body COCIR has joined forces with representatives from industries within and outside health care to warn that the European Commission’s proposed EU Data Act is a “huge leap into the unknown.”
The ENT specialist reportedly purchased only 36 single-use sinus devices but performed at least 1,400 procedures. She could land up to 40 years in prison after being convicted on 20 counts including device adulteration, conspiracy, and fabricating medical records.
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.
The omnibus spending bill passed at the end of 2022 requires clinical trial sponsors to submit a diversity action plan to the US Food and Drug Administration. Attorney Faraz Siddiqui, who coauthored a blog post on the new regulation, spoke to Medtech Insight about the requirement and the push to increase diversity.
In this episode of new podcast series Medtech Connect, Medtech Insight’s regulatory writer for Europe, Eliza Slawther, interviews Alexander Olbrechts, director for digital health at the European trade body MedTech Europe, to find out more about the proposed European Health Data Space initiative and what it means for the medical device industry.
The US Food and Drug Administration published three device-related warning letters in January – two that went to divisions of endoscope vendor Olympus, and one to a Maryland vision treatment firm.
ECRI says gaps in communication about recalls of medical devices used at homes pose a significant risk to patients. The nonprofit safety organization’s list of the top ten technology hazards for 2023 put lack of communication at the top.
Following Sterigenic’s $408m EtO settlement, a securities class action lawsuit has been filed against its parent company Sotera Health Company.
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