The US Centers for Medicare and Medicaid Services plans to automatically allow reimbursement and up to 65% new technology add-on payments for US FDA-approved, -cleared or de novo devices in the agency's Breakthrough Devices Program. Industry groups, including the Medical Device Manufacturers Association and AdvaMed, have been pushing CMS for such coverage for several years.

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

Cambodia’s regulatory framework needs an overhaul, according to the World Health Organization, which has issued a tender for interested parties to review the current situation and produce draft legislation that meets current international norms.

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.

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a nickel-titanium alloy ubiquitous in medical devices, is getting more scrutiny from US FDA in a recently released draft guidance.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 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 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A new draft guidance document from the agency says domestic inspections should occur over a brisk three to six consecutive days, alleviating a pain point for device firms that say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.

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.

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.

Philips CEO Frans von Houten sat down with Medtech Insight for an exclusive podcast chat on the company’s philosophy for artificial intelligence and what is needed to fully embrace the technology as health-care systems evolve.

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.

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.

Investigations into violations of National Institutes of Health grant-funding rules targeting scientists from China and other countries working on genomic research have already resulted in three firings at a famous cancer center in Houston.

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.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved BaroNova's TransPyloric Shuttle and its delivery system to treat obesity. It also cleared NeuroSigma’s Monarch external trigeminal nerve stimulation system, making it the first FDA-approved device for treating attention deficit hyperactivity disorder.

Patients treated with the TransPyloric Shuttle in the 213-patient ENDObesity II trial lost an average of 9.5% of their body-weight and 30.9% of their excess weight.

US Senators are speaking out about the ongoing FBI investigations into Chinese researchers accused of using National Institutes of Health (NIH) genetic testing research and grants and stealing US institutions’ intellectual property to establish “shadow laboratories” in China with access to Americans’ genomic data.