No device-related warning letters were released by the US FDA the week of 22 October.

The EU MDR represents the biggest collective change in many years for medtech companies in terms of how they prepare their approach to market. With time running short for companies’ preparations ahead of the regulation’s implementation date of 26 May next year, the UK ABHI’s final pre-MDR regulatory conference in late October will be both a check list for companies en route to compliance and a debate about the wider role of risk in regulatory compliance.

AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies, among others on how to pay for new digital-health products. See what Zach Rothstein, AdvaMed's VP for technology and regulatory affairs, said about it here.

As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.

Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Device Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.

New Orleans-based UTC Laboratories agreed to pay $41.6m to resolve alleged violations of the False Claims Act, the US Department of Justice (DOJ) announced recently. See what CJ Porter, special agent in charge with the Department of Health and Human Service Office of the Inspector General, said about it here.

Eric Henry with the law firm King & Spalding says that while software cybersecurity patches typically don't rise to the level of a recall, device-makers should still consider the cumulative effect of software changes on products.

In the only device-related warning letter released by the US FDA this week, a manufacturer of a dental X-ray sensor and X-ray system was cited for quality systems violations. The firm also failed to notify the agency of accidental radiation occurrences.

On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.

With the US FDA urging providers to transition away from fixed duodenoscopes to newer designs that reduce or eliminate reprocessing of the device, Pentax Medical is seizing an opportunity to increase supply of its disposable cap scope. Medtech Insight talks to the company’s global clinical officer, Garrett Hudson, on the challenges of endoscopy hygiene and the company’s response to guidance.

In this edition of Device Week, Medtech Insight managing editor Marion Webb chats with deputy editor Reed Miller about the most recent earnings report from Johnson & Johnson, and talks with London-based Catherine Longworth about her upcoming "taboo" tech coverage from the 2019 Global Innovation and New Technology Health Event (GIANT).

Johnson & Johnson's medical device businesses grew 5.3% on an organic basis in the third quarter led by the Bioscience Webster electrophysiology unit. See what Ashley McEvoy, Johnson & Johnson's worldwide chairman for medical devices, said during the earnings call here.

Johnson & Johnson's medical device businesses grew 5.3% on an organic basis in the third quarter, led by the Biosense Webster electrophysiology business. The company is increasing R&D investment, especially in robotic surgery, to boost its surgery and orthopedics businesses.

CEO of molecular diagnostics firm Qiagen steps down after decades of service; Halma division chief steps up to medical and environmental sector chief exec; and more.

Abbott signed a deal with Tandem Diabetes Care to develop diabetes solutions combining Abbott's glucose-sensing technology with Tandem's insulin delivery systems. See what Tandem's CEO and president, John Sheridan, said about the partnership here.

In this edition of Device Week, Medtech Insight managing editor Marion Webb chats with deputy editor Reed Miller about the most recent earnings report from Johnson & Johnson, and talks with London-based Catherine Longworth about her upcoming "taboo" tech coverage from the 2019 Global Innovation and New Technology Health Event (GIANT).

The Echelon circular powered stapler for colorectal, gastric and thoracic surgery features Ethicon’s 3D stapling technology to evenly distribute compression and a gripping-surface technology that reduces compressive forces on tissue. The company expects the new system will reduce leaks at the staple line without compromising blood or lymphatic perfusion.

The Merlin 10.0 update to Abbott’s its Merlin patient care network, which works with the CardioMEMS HF sensor system, allows physicians to communicate directly with patients.

In this week's podcast, senior reporter Catherine Longworth provides an update on how the Demant Group is recovering from a ransomware attack that forced the Danish hearing-aid manufacturer to shut down its IT systems, and deputy editor Reed Miller reviews the highlights of the clinical trial presentations at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

Intervention with Abbott’s Xience everolimus-eluting stent yielded similar long-term results as bypass surgery in the EXCEL trial.

Abbott’s Portico transcatheter aortic valve performed well enough to meet the statistical criteria for non-inferiority to surgery in the PORTICO IDE trial. The company will likely look to its next-generation of Portico for more impressive results.