How do notified bodies ensure that their personnel, and the teams they allocate for conformity assessment of medical devices, have the precise knowledge and expertise needed? A new EU document gives guidance on this.

US congressional leaders and medtech industry advocacy group AdvaMed are giving their full-throated endorsement to a US-Mexico-Canada (USMCA) trade agreement announced by the US Trade Representative's Office on 10 December. See what AdvaMed's president and CEO, Scott Whitaker, said about it in a statement here.

No device-related warning letters were released by the US FDA the week of 10 December.

Stephen Hahn, the Trump administration’s nominee to lead the US FDA, has been approved by the Senate Health, Education, Labor and Pensions (HELP) Committee, with some “no votes” from Democratic senators in leadership positions, and is expected to be considered by the full Senate this week.

The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.

Not only is the EU due to be endorsing key guidance documents this week, but recent headline  topics, including appointing expert panels and the delay in setting up the Eudamed database feature on end of week Medical Devices Coordination Group meeting agenda.

Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.

Device makers should make sure they have adequate resources to analyze quality data they take in so they can prevent the recurrence of nonconforming products, processes and procedures. That’s just one nugget of advice from former FDA investigations branch director Ricki Chase, who explains why collecting and properly handling such data is critical to complying with agency expectations in this Medtech Insight Q&A interview.

In the only device-related warning letter released by the US FDA this week, a manufacturer of surgical trays and kits was cited for quality systems violations.

ConMed’s ambitions in orthopedics are to be the clinician’s support, develop differentiated offerings and avoid “me too” activity, before all notions of leading the market rankings.

The US Patent Office has rejected a request by Edwards Lifesciences to review an Abbott patent on heart-valve technology, which could establish the patent as a key part of Abbott Laboratories’ arguments in a larger ongoing intellectual property case.

The global insulin pump market is expected to see significant growth, reaching $5.1bn by 2023. A new Market Intel story looks at the competitive landscape of the three leading companies in this market, Medtronic, Insulet and Tandem Diabetes Care, which are all expected to launch new products in 2020. See what Viral Shah, an assistant professor of medicine and pediatrics at the University of Colorado, said about the diabetes market here.

The insulin pump market is expected to grow to $5.1bn by 2023, driven by the increasing incidence of diabetes and adoption of next-generation hybrid closed-loop systems, which allow patients and health-care providers to better manage care. This first part of a two-part series highlights the rising competitive landscape of the four major players, Medtronic, Insulet, Tandem Diabetes Care and Valeritas, with insights from endocrinologists. The second part will look at the smaller players, which are gearing up to introduce new products in 2020.

CMR Surgical CEO Martin Frost is making way for a new boss to lead the surgical robotics company. Per Vegard Nerseth is set to join CMR Surgical in January 2020 as the company gears up for its most ambitious year yet.

Koa Accel CEO Francis Duhay tells Medtech Insight what his company looks for when choosing medtech ideas to support and how his experience as a physician and inventor informs his investment strategy.

An overview of November’s 10 most-read Medtech Insight articles on topics related to research and development of new medical technology.

Artificial intelligence (AI) and machine learning took center stage at this year’s Radiological Society of North America meeting in Chicago, and the pervasiveness of AI tech in new product launches was further emphasized at the RSNA’s expanded AI Showcase exhibit.

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

The results from the PROMISE I feasibility study give LimFlow confidence that the PROMISE II pivotal trial will prove that the LimFlow percutaneous deep vein arterialization system is a safe and effective alternative to amputation for patients with critical limb ischemia.

Registry data from France shows transcatheter aortic valve replacement patients have better outcomes with Edwards’ Sapien balloon-expandable valves than with Medtronic’s CoreValve self-expanding valves.

The US FDA has cleared the Pentax Medical Video ED34-i10T2, the first duodenoscope for the US market with a sterile, disposable elevator component designed to reduce the number of parts that need to be disinfected between uses. See what Jeff Shuren, director of the agency’s device center, said about it here.