Philips CEO Frans von Houten says the future of health care is in AI platforms that will transform how effectively and efficiently patients are treated. He predicts the technology will be so ubiquitous that users will not even realize they are interacting with the technology.

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.

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.

Philips CEO Frans von Houten says the future of health care is in AI platforms that will transform how effectively and efficiently patients are treated. He predicts the technology will be so ubiquitous that users will not even realize they are interacting with the technology.

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.

Arizona-based GT Medical Technologies is ramping up commercialization of its GammaTile surgically targeted radiation therapy for patients with recurrent intracranial neoplasms. GammaTile already received 510(k) clearance, but continues to develop clinical evidence showing that GammaTile improves control of brain cancer following excision surgery and prolongs patient-survival.

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.

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.

Medtronic is encouraged by new data on endovascular repair of abdominal aortic aneurysm presented at the Charing Cross Symposium, including preliminary data from the ANCHOR registry on Endurant used in combination with the Heli-FX Endoanchor system. At the same meeting, 30-day results from 100 patients in the pivotal trial of Valiant Navion thoracic stent graft system showed high rates of procedural success in patients with a thoracic aortic aneurysm and penetrating atherosclerotic ulcer.

New trial results show Guardant Health's Guardant360 largest cell-free DNA assay rapidly identifies biomarkers for metastatic non-small cell lung cancer associated with specific therapies at least as accurately as standard-of-care tissue genotyping.

Five-year outcomes from the VeClose Extension Study at the 2019 Charing Cross Symposium in London show the aggregate complete closure rate of the great saphenous vein was 94.6% in chronic venous disease patients treated with VenaSeal.

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.