The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.

In this week's Medtech Insight podcast, Shawn M. Schmitt explains why the FDA ordered transvaginal mesh products removed from the US market, and Ferdous Al-Faruque highlights a growing device-shortage issue linked to problems at two US sterilization facilities.

The World Health Organization has framed a policy to help suppliers, donors, procurers and distributors manage medical products throughout the supply chain and ensure availability within their remaining shelf-life.

With just over 13 months until the EU Medical Devices Regulation is fully applicable, EU medtech manufacturers are imploring the European Commission to speed readiness of the new regulatory system or patients and industry will suffer.

In his first speech to agency staff, US FDA acting Commissioner Ned Sharpless says the agency will continue working on issues such as the Medical Device Safety Action Plan, the precertification program and the National Evaluation System for health Technology (NEST). He also says he's not approaching the post like a temporary caretaker.

The World Health Organization has framed a policy to help suppliers, donors, procurers and distributors manage medical products throughout the supply chain and ensure availability within their remaining shelf-life.

Medtronic quality VP Luann Pendy worked with the US FDA and the Medical Device Innovation Consortium through its joint Case for Quality devise a so-called "#makeCAPAcool" initiative to recast corrective and preventive action as a continuous learning tool. See what Pendy said about the "monster called CAPA" here.

The so-called "#makeCAPAcool" group wants to recast corrective and preventive action as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. A new voluntary CAPA framework developed by the team and piloted by a handful of device-makers will be rolled out later this year.

GT Medical Technologies Inc. launched GammaTile permanent intracranial brachytherapy device, designed to be placed in the space left after the excision of a brain tumor. See what GT Medical Technologies' CEO and president Matt Likens said about it here.

Medline Industries will pay $167.5m for the Namic brand of manifolds, contrast management systems, closed fluid systems, guidewires, disposable transducers and interventional accessories. It also includes a manufacturing facility and the manufacturing, sales and marketing staff that support Namic.

Medical products firm Midmark Corp. names a new VP of Corporate Accounts; ortho implant-maker Episurf Medical designates a COO; digital-medicine developer Akili Interactive Labs hires a new CFO; and more.

QuantumMDx Group Ltd has signed a deal with GlaxoSmithKline to co-develop a quality control analytics system for cell and gene therapies.

Two dozen telemedicine executives, durable medical equipment vendors and health-care providers have been indicted as part of what the US Department of Justice calls “one of the largest health-care fraud schemes” in recent years.

The Woven EndoBridge (WEB) aneurysm embolization system proved relatively safe and effective in the 150-patient WEB-IT trial. The trial results are now published in the Journal of Neurointerventional Surgery.

Carmat suspended the production of its Total Artificial Heart while it strengthens certain manufacturing processes.

PureTech's affiliate Gelesis has received US FDA de novo clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.

The approval of the Intact's peripheral artery dissection repair device is based on results from the 213-patient TOBA II trial, which showed Tack resolved 92.1% of dissections in peripheral arteries following balloon angioplasty.

The Therascreen FGFR kit helps identify urothelial tumors with alterations to the fibroblast growth factor receptor 3 gene that indicate the cancer will respond to Janssen’s new drug Balversa.