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.

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.

No device-related warning letters were released by the US FDA the week of April 16.

The US FDA continues to find unacceptable levels of “high concern” disease-causing bacteria on duodenoscopes that have gone through cleaning and reprocessing steps, and is poised to take further action with three duodenoscope manufacturing firms to reduce patient risks.

Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.

The new EU medical device regulations  ̶  the MDR and IVDR – left a gap in how manufacturers of legacy products should comply with critical reporting requirements. A solution has been found.

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.

A new draft guidance document from the agency says domestic inspections should occur over a brisk three to six consecutive days, alleviating a pain point for device firms that say some agency investigators traipse in and out of an audit, sometimes causing inspections to drag on for weeks.

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.

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.

SOPHiA GENETICS received the CE-IVD mark for its molecular diagnostic device, Solid Tumor Solution (STS). See what the company's genomics senior VP, Gioia Althoff, said about it here.

SOPHiA GENETICS has scored a CE-IVD mark for its molecular diagnostic device, Solid Tumor Solution (STS). 

The US Federal Trade Commission has finally approved Fresenius' $2bn acquisition of NxStage Medical. A complaint filed by the FTC in February 2019 claimed the deal would be anti-competitive.

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 Recell system of Spray-On Skin Cells combined with mesh autografts healed 98% of burns within four weeks in 23 pediatric patients treated under US FDA-approved compassionate use and continued access programs.

SPR Therapeutics' Sprint percutaneous peripheral nerve stimulator proved safe and effective at reducing pain in post-amputation patients in a new 28-patient randomized study.

One-month results from the CLASP trial, presented at the German Cardiology Meeting (DGK), show Edwards’ Pascal mitral valve repair device reduces mitral regurgitation in heart failure patients with moderate to severe mitral regurgitation.