No device-related warning letters were released by the US FDA the week of April 23.

US legislators accuse the Chinese government of recruiting and subsidizing US NIH-funded Chinese researchers to steal US-owned genetic research and intellectual property, cheating the peer review system, and establishing US-connected lab facilities with access to US citizens' genomic data. See what US Senator Roy Blunt said about it here.

Nitinol, a nickel-titanium alloy ubiquitous in medical devices, is getting more scrutiny from US FDA in a recently released draft guidance. As safety concerns have arisen in the past few years over biocompatibility of certain materials in implanted products, the agency is asking device makers to provide additional information on nitinol in their device submissions.

The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.

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.

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.

The global market for arthroscopy products and sports medicine implants is expected to reach $9.0bn by 2023, a CAGR of 4.2% from $7.3bn in 2018, driven in part by the rising availability of arthroscopy at ambulatory surgery centers in many countries, expanding indications for arthroscopic repair, patient preference for minimally invasive procedures and advanced techniques.

Philips' CEO Frans van Houten spoke about his vision for the company's continued adoption of machine learning and artificial intelligence at the World Medical Innovation Forum in Boston. See what van Houten said about it here.

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.

Product liability cases alleging manufacturers of pelvic mesh are responsible for patient injuries continued even as the US FDA is halting sales of the product. In the most recent verdict, a Philadelphia jury said Johnson & Johnson was not responsible for adverse events experienced by a Pennsylvania woman.

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.

SurModics suspended the trial with their SurVeil drug-coated balloon in March after the US FDA sent a letter to physicians alerting them to possible safety problem with paclitaxel-coated devices. The company has updated the patient consent form and established a new patient follow-up program for the trial.

The study will be expanded by 50 patients, for a total of 220 subjects, based on the recommendation of a statistician who reviewed an interim analysis. RECON is intended to support a Biologic License Application for Avance, a processed human nerve allograft for bridging severed peripheral nerves.

The de novo clearance is based on the results of a 62-patient phase II sham-controlled trial. Patients in the treatment group showed more improvement in attention deficit hyperactivity disorder symptoms over four weeks than patients treated with a placebo device.

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.