Louisiana-based pharmacogenetic testing company UTC Laboratories and its three principals have agreed to pay $42.6m to resolve allegations that the company violated the False Claims Act by paying kickbacks for referrals and providing tests that were not medically necessary.

The Brexit withdrawal deal agreed by the UK and the EU on 17 October would see the UK leave the EU at the end of the month, but would allow time to negotiate the future trading and regulatory relationship between the two parties. However, the deal still faces a rough passage in the UK parliament.

Today is John Wilkinson’s last day as head of devices at the UK’s MHRA. It looks like his successor will be someone who can ably assist in the transition ahead, as the UK copes with upcoming Brexit arrangements and the EU attempts to successfully implement the new Medical Device and IVD Regulations.

The European Commission has only just published its MDR guidance document on medical device software, but one expert contends that it contains inconsistencies and errors, and is proposing a new classification approach.

A bill that would promote genetic testing for infants and children, introduced by California Rep. Eric Swallwell, is gaining support in the US House of Representatives.

Forthcoming requirements under the EU’s new Medical Device Regulation are creating upheaval for the medicinal products industry, unaccustomed to engaging with notified bodies and unfamiliar with the loose timelines that the medtech industry operates within. Will an increase in joint working, joint documents and  general crossover between the drug and device sectors smooth the way?

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.

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.

Abbott signed a deal with Tandem Diabetes Care to develop diabetes solutions to combine Abbott's glucose-sensing technology with Tandem's insulin delivery systems.

Abbott signed a deal with Omada Health to integrate Abbott's FreeStyle Libre with Omada's health coaching platform.

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.

An analysis of the PARTNER 3 trial shows transcatheter aortic replacement with Edwards Sapien 3 yields better health status outcomes than surgical valve replacement after one year.