Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Most low-risk medical devices and IVDs do not need notified body involvement in the EU. This means that, in the event of a no-deal Brexit, they are not impacted by UK government rules that focus on notified bodies. But what will change for low-risk devices and IVDs in the UK post-March 29, the UK's scheduled EU exit day?

The Therapeutics Goods Administration has begun a second public consultation on how it intends to improve its rules for 3D-printed and other personalized medical devices after stakeholders called for more clarification to proposals made in 2017.

Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the new EU Medical Device and IVD Regulations, and they spell out some of the challenges companies have encountered during a panel discussion at the recent LSX World Congress in London.

At a recent meeting, a US FDA advisory committee cautioned the agency to very carefully consider risks and benefits prior to agency approval of any new pelvic mesh products. See what Public Citizen's Michael Carome said about it here.

The US Centers for Medicare and Medicaid Services loosened its long-running noncoverage policy for vagus nerve stimulation for treatment-resistant depression a little bit, with a tightly controlled coverage-with-evidence-development policy. Device-maker LivaNova hopes to launch a Medicare-covered study later this year.

Device manufacturers would be able to get nonbinding feedback on their plans for how to resolve some Form-483 inspectional observations from US FDA officials under a new draft guidance released Feb. 15.

A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.

The upcoming voluntary global standard F3306 aims to improve the safety of surgically implanted medical devices. F3306 describes a novel test method that assesses metal and other ions released from single-use, metallic, implantable devices, and their components.

Chronic pain treatment company Nevro has filed suit against rival Stimwave Tech alleging patent infringement.

MDx Health has named a new CEO to lead its commercial growth following a disappointing set of results in 2018.

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 Feb. 11 - 17, 2019.

The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be offered to all patients with a history of breast cancer. See what the American Society of Breast Surgeons' president said about it here.

Johnson & Johnson announced it will acquire robotic startup Auris Health for $3.4bn in cash, plus up to $2.4bn in milestones. See what Wells Fargo analyst Larry Biegelsen wrote about it here.

MDx Health has signed an exclusive distribution deal to make its liquid biopsy prostate cancer test available in Canada.

The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be made available to all patients with a history of breast cancer. The new recommendations are not in line with existing guidelines made by the National Comprehensive Cancer Network.

In this edition of Device Week, Medtech Insight’s Reed Miller talks to managing editor Marion Webb about the growing interest among investors in "femtech," technology that specifically addresses women's health issues that have been frequently overlooked in the past. And London-based reporter Catherine Longworth addresses the recent media reports that Smith & Nephew may make a bid for spine-device company Nuvasive.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, two spine device approvals from US FDA, and a CE mark for a new drug-eluting stent.

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 1 through Feb. 10, includes published results from trials of Global Kinetics’ Personal KinetiGraph movement recording system for Parkinson’s disease patients, Milestone Scientific’s CompuFlo Epidural System for epidural-block anesthesia, and Leviticus Cardio’s wireless Coplanar Energy Transfer system for left-ventricular assist devices.

Results of a study published in December found that left-side circulatory support with an Impella pump was not associated with lower 30-day mortality compared with matched cardiogenic shock patients treated with an intraaortic balloon pump (IABP) or medical therapy.

FDA sent a letter to physicians alerting them to interim results from the post-approval study of Abiomed’s Impella RP right-heart pump system that suggest a higher mortality rate for patients than what was observed in pre-market studies. FDA believes the benefits of the Impella RP system continue to outweigh the risks for patients covered by the currently approved indication; it emphasizes to physicians the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients. The results cited by FDA were announced about two months after results of a non-randomized study in Germany cast doubt on the benefits of Impella for left-sided support in cardiogenic shock patients.