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Enforcement & Litigation

Set Alert for Enforcement and Legislation

All Eyes On US Patent And Trademark Board As ITC Approves Apple Watch Import Ban

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.

Intellectual Property Regulation Companies

EU Opening Pandora’s Box With Data Act, Warns Medical Imaging Body COCIR

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.”

Europe EU

North Carolina Doctor Convicted For Reusing Sinus Surgery Devices

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. 

Policy Legal Issues

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.

Regulation Recalls

Legal Expert Weighs In On New US Mandate To Diversify Clinical Trials

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.

FDA Diversity & Inclusion

Medtech Connect Episode 2: What Is The European Health Data Space?

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.

Europe EU

Warning Letter Roundup & Recap – January 2023

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.

Regulation FDA

What We Have Here Is A Failure To Communicate

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.

FDA Regulation

Sotera Health Class Action Suit: Executives ‘Misled Investors’ During Public Offerings

Following Sterigenic’s $408m EtO settlement, a securities class action lawsuit has been filed against its parent company Sotera Health Company.

Legal Issues Regulation
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