The new Eudamed database may be delayed for two years, but the European Commission wants to allow early access to Single Registration Numbers before Eudamed goes live in 2022 to aid voluntary registration in the interim.

The US FDA has qualified a new modeling tool that could give sponsors more assurance that their products meet the agency’s expectations for MRI-compatibility.

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.

Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.

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

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.

In this edition of Device Week, Medtech Insight's deputy editor Reed Miller chats with managing editor Marion Webb about her latest in-depth Market Intel story, the first part of a two-part series focusing on the competitive landscape of the global insulin pump market.

ConMed Corp. is company of two halves  ̶  general surgery and orthopedics – and is readying itself for a renewed assault on these two markets on the back of a technology pipeline, targeted acquisitions and a new growth-winning culture, says CFO Todd Garner.

Owens & Minor finance boss joins drug-delivery device maker Intersect ENT; operations VP at MicroPort joins bioprosthetic heart maker Carmat; Dynatronics CEO will head neuromodulation product firm BrainsWay in January; and more.

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.

Corindus Vascular Robotics Inc. expects its CorPath GRX robotic intervention system will eventually be part of a widespread system of "telerobotic" intervention sites operated by specialists located far away. See what Tejas Patel, an interventional cardiologist at the Apex Heart Institute in Ahmedabad, India, said about it here.

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.