No device-related warning letters were released by US FDA the week of Dec. 18.

A variety of factors is causing US citizens to pay anywhere from four to six times more for their cardiac implant devices than patients in Germany, Italy and the UK, says a recent blog piece by Cornelia Henschke and Rita Redberg in Health Affairs.

US FDA’s device center in concert with third-party servicers and original equipment manufacturers are working toward consensus on how to differentiate medtech "servicing" from "remanufacturing" activities. Progress was made at a recent workshop in laying out ways that better training and more data sharing will help.

The European Commission looks to be on track, and in some cases ahead of schedule, in steps toward the designation of notified bodies under the new EU device and diagnostic regulations. But could recent bad press create delays?

FDA is considering publishing a list of devices 510(k)-cleared based on predicates over ten-years-old to encourage companies to adopt new predicates. In a joint written response to Medtech Insight's questions, medical device regulatory experts with law firm King & Spalding said an age-based cut-off will not necessarily address the problem FDA is trying to address.

A revised bill is circulating in both the US House and Senate to revamp FDA regulation of diagnostics. It would allow the agency to leverage a pre-certification process to validate test developers and includes other updates that are likely to appeal to the lab sector. But user fees and other elements could still be contentious.

Olympus Medical Systems and a former senior executive have pleaded guilty to allegations that they sold duodenoscopes even after failing to submit required adverse-event reports on them.

Requirements for Unique Device Identification (UDI) will ultimately apply to all medtech manufacturers selling products in Europe. The upcoming mandates are complex and technical both for those developing UDI standards and for industry. Medtech Insight looks at progress so far on an EU UDI system, and sheds light on developments, terminology and how the system links together.

An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Dec. 10-16, 2018.

Finnish molecular diagnostics company Mobidiag is partnering with Chinese company Autobio Diagnostics in a new joint venture to commercialize its Novodiag platform for infectious disease diagnostics.

Europe's biggest medtech industry and market, Germany, was in the crosshairs of the Implant Files and its ICIJ reporters, and predictably it caused a major stir. The episode has been a wake-up call for medtech, but industry hasn't let it develop into the crisis it briefly threatened to become, and is now looking beyond it and to the commercial challenges of 2019.

FDA has given Israeli company Check-Cap the green light to initiate a pilot study of its C-scan system for colorectal cancer screening.

CarThera has secured its first financial round from institutional investors to launch a pivotal trial evaluating the company's Sonocloud ultrasound therapy for patients with recurrent glioblastoma.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include US FDA approval of Medtronic's Resolute Integrity and Resolute Onyx zotarolimus-eluting coronary stents, and agency approval and a CE mark for InSightec's ExAblate ultrasound device for treating tremor-dominant Parkinson's disease.

This week's edition of Medtech Insight's Results Recap, the weekly round-up of major device trial-results, features just one entry - long-term data from a prospective, non-randomized, single-arm anatomic and clinical evaluation of chronic refractory angina patients implanted with Neovasc's Reducer at a single medical center as part of the first-in-human clinical study in 2005. The patients treated in the trial showed sustained improvement in angina class out to 12 years and all seven Reducers implanted in the study were still patent, with no signs of strut fractures, dislocation, thrombosis, or migration.

Brexit, the "Implant Files" and the new EU regulations – however large they loom at present, they will in time be seen as mere tactical challenges for a global medtech industry working hard to ensure that it is ready for the massive health-care delivery and service-oriented changes to come. Preparing for the future and maximizing current market penetration – in the UK, the EU and beyond – were key themes at UK HealthTech 2018, held in Cardiff, Wales.

In this edition of Device Week, Medtech Insight’s weekly podcast, Marion Webb gives an overview of physicians’ perspective of digital apps for diabetes patients and Reed Miller discusses the early research into a potentially promising non-invasive radiation technique for treating ventricular tachycardia.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include an endobronchial valve for emphysema approved in the US and an autologous cell therapy for urinary incontinence approved in Japan.