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

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 Therapeutic Goods Administration says it now has enough evidence to warrant cancelling, suspending and recalling a number of textured breast implants because of the potential risks of developing anaplastic large cell lymphoma.

Industry and the European Commission have been at loggerheads over whether the new EU Medical Device Regulation will be ready on time and whether a further extension is needed. Could recent notified body developments fuel the case for an extension?

Cardiologists and radiologists spoke in support of new technology add-on payments for Boston Scientific’s Eluvia drug-eluting stent, used to treat patients with peripheral artery disease, in comments on the US Medicare agency's Inpatient Prospective Payment System (IPPS) rule for 2020, despite concerns about paclitaxel-coated stents discussed at a late June US FDA Advisory Committee meeting.

In terms of a no-deal Brexit, the UK MHRA had drawn up its plans for medtech several months ago and is sticking by them. But even though manufacturers seemingly have more time to prepare for the delayed Brexit deadline, they should not underestimate the volume of work ahead.

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.

Guest authors Laura Dhatt and Paul Kostek of software engineering services firm Base2 Solutions offer device-makers pointers on how to mitigate certain risks and make sure that safety is always a top concern when products are designed.

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.

The global market for implantable cardioverter defibrillators (ICDs) is expected to reach $10bn by 2023, a CAGR of 4.4%, driven by the rising prevalence of heart disease worldwide. This market is dominated by three players, Abbott, Boston Scientific and Medtronic, which continue to innovate. Cost of ICDs and surgical implantation remain barriers to wider adoption, but access to emerging markets is expected to drive sales.

The Medical Device Manufacturers Association (MDMA) on 10 July praised US Senate reintroduction of the STRONGER Patents Act, designed to strengthen the US patents systems by making it easier and less costly for patent-holders to enforce their patents, including those which are the intellectual property of device-makers.  Mirror legislation was simultaneously proposed in the US House.

This year, Omron Healthcare introduced its new HeartGuide smartwatch and the first US FDA-cleared blood pressure monitor with EKG capability, Complete, which it developed in partnership with AliveCor. See what Omron's CEO, Ranndy Kellogg, said about the company's plans here.

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.

Switzerland-based robotics company Distalmotion hopes to win marketing approval in Europe for Dexter, a robotic surgery system designed to help surgeons with long and complex surgical tasks. See what Distalmotion's CEO Michael Friedrich said about it here.

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.

An analysis of pooled five-year data from the PROTECT AF and PREVAIL trials, show left-atrial appendage closure to prevent stroke in patients with atrial fibrillation is not only cost‐effective compared to treatment with warfarin and other anticoagulant drugs, but saves money over time.