The US FDA's Suzanne Schwartz says a new law might be the antidote to companies that willingly hide cybersecurity vulnerabilities to avoid concerning their customers. Check out her comments here.

An Australian proposal to establish a regulatory framework for companion diagnostics has drawn a mixed response from pharmaceutical, biotech and medtech companies on issues like concurrent evaluation, product classification and unique identification.

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

The European Commission’s latest figures indicate that at least 20 notified bodies will be designated by 26 May 2020 - the date by which the new medical device regulation will become fully applicable. But is there still enough time?

The European Commission’s long overdue MDR/IVDR standards request document – still a draft – gives the European standards bodies just over a week from today to respond. But CEN/Cenelec says it cannot reply yet. So what is the problem?

A ventilator error message that leaves patients breathing room air has led to a high-risk class I recall for Hamilton Medical.

Peter Shearstone, VP of global quality assurance and regulatory affairs at in vitro diagnostic test-maker Thermo Fisher Scientific, is dismayed that only two IVD manufacturers are playing in the US FDA's Case for Quality Voluntary Improvement Program to measure manufacturing maturity and quality – and his firm isn't one of them. "Part of my challenge is moving my company toward proactivity, and if [CFQ VIP] can help do that, then I'd be hypocritical if I didn't embrace it," he says.

The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.

US FDA investigator and medical device specialist Thomas Peter says workers at device companies often fail to identify nonconforming products and don't adequately document troubles when they're discovered. Using quality audits is one way to nip this problem in the bud, he explains.

Johnson & Johnson’s leadership remains optimistic about the future of its medical device divisions despite reporting a 2.6% revenue decline in the first six months of 2019 compared to the same period of 2018.

Prompted by a presidential executive order on advancing kidney health, the US Medicare agency has proposed five new end-stage renal disease (ESRD) payment models to encourage greater use of home dialysis and kidney transplants to Medicare and Medicaid beneficiaries.

Nevro, a pain device company, added a chief commercial officer from Abbott Vascular; Integra Lifesciences moved its top finance boss to chief operating officer; a Spinal Kinetics exec joined orthobiologics company Cerapedics to lead its clinical and market development; and more.

Liquid biopsy technology is drawing increasing attention from regulators, big manufacturers and investors alike as recent developments in this field show. See what Johns Hopkins's head of technology ventures, Christy Wyskiel, said about it here.

The global market for prostate cancer diagnostics is expected to see double-digit growth, reaching $460.5m in 2023 and is driven by new technologies, in particular liquid biopsies and new genetic marker tests, according to a new report by Informa's Meddevicetracker.

A new multinational study by sleep device-maker ResMed and 12 academic leaders in sleep research found that nearly one billion people worldwide have sleep apnea, about 10 times higher than previous estimates by the World Health Organization. See what study co-author and ResMed's CMO, Carlos Nunez, said about it here.

Siemens Healthineers and the University of Missouri System and Missouri Health Care entered a 10-year strategic alliance worth $133M to collaborate on research projects, develop student curricula and leverage digital technology to drive health care. 

New final guidance from the US FDA sets out the agency’s expectations for the use of live-case presentations during device clinical trials, focusing on patient protection.

The growth potential of liquid biopsy diagnostics is drawing increasing attention, with several recent breakthrough device designations from the US FDA, big funding rounds, and major acquisitions all in play.

A new analysis suggests that Boston Scientific Corp.'s Watchman left-atrial appendage closure device is a cost-effective alternative to warfarin or other anticoagulant drugs for patients with atrial fibrillation. See what Vivek Reddy of the Mount Sinai Hospital said about it here.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 2 July to 8 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, de novos, or non-US approvals.

In this edition of Device Week, Medtech Insight’s Marion Webb reviews her interview with Omron Healthcare CEO Ranndy Kellogg at the recent AdvaMed conference in San Francisco. Reed Miller discusses the latest cost-effectiveness study of Boston Scientific’s Watchman left-atrial appendage closure device.