The US Medicare agency has decided that evidence is sufficient to cover ambulatory blood pressure monitoring to help diagnose hypertension in beneficiaries who suffer from white coat high blood pressure, and those with suspected masked hypertension.

Trying to meet standards that are currently in a state of flux and which are the source of more uncertainty adds another layer of stress to medtech manufacturers already trying to comply with an incomplete medtech regulatory structure.

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.

Some implanted hearing devices, such as cochlear implants, may magnetically interfere with programmable cerebrospinal fluid shunt systems, the US agency says.

Regulators are reaching out to industry and the public-at-large for ideas that would help develop new sterilization methods that could reduce or replace the need for ethylene oxide used to treat difficult-to-clean medical devices. They are also looking for ways to reduce the risk and environmental impact of the sterilizing agent.

The World Health Organization has added cancer diagnostics, blood-transplant screening and more to an updated list of essential diagnostics.

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.

Intuitive Surgical reported on 18 July that worldwide da Vinci procedures were up about 17% in the second quarter of 2019 compared to the same period of 2018. While the US still accounts for the majority of Intuitive’s revenue, procedure volume outside the US is growing faster, especially in Asia.

Orthopedic implant company Arthrosurface is hoping to get hand surgeons' attention with its new allograft thumb implant to treat osteoarthritis.

Abbott Laboratories plans to invest significantly to expand manufacturing capacity for its FreeStyle Libre continuous glucose monitoring system in an effort to meet demand. See what Abbott CEO Miles White said about it here.

A crop of new US consumer protection state laws and proposed federal legislation is aimed at stopping medical specialists from the practice of balance billing.

Accelerating technological innovation, reimbursement and legislative changes are expected to make a significant impact on the global market of injection devices and related products. According to Informa's new Meddevicetracker report on "Infection Control and Biosafety Products," the combined market of these devices will reach $4bn by 2023.

Consort Medical issued a profit warning following a factory explosion. The company said the incident is likely to cut between £3-5m from its annual profits.

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.