The agency has republished two guidance documents outlining conditions for when it could not accept a 510(k) or PMA application for review to incorporate regulatory updates. While the changes are minor, FDA hopes they will continue to give sponsors enough detail to reduce the number of applications that get turned away for lack of basic information.

Legal experts say recent court cases and a new guideline from the US Patent and Trademark Office on patent-eligible subject matter have created a lot of ambiguity for companies. See patent advice from Harness Dickey attorney Chris Cauble here.

A regulation finalized last year kicks in today requiring companies to either include along with US FDA submissions a statement affirming Good Clinical Practice compliance for any data collected outside the US, or get a waiver.

Device-maker LivaNova will put its vagus nerve stimulation system to another sham-controlled test in patients with treatment-resistant depression by leveraging a newly finalized Medicare national coverage determination, which covers patients with bipolar disease. See what LivaNova CEO Damien McDonald said about it here.

Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

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.

Bioresorbable-polymer, sirolimus-eluting Orsiro outperformed Abbott’s market-leading Xience durable-polymer, everolimus-eluting stent at the two-year follow-up in the BIOFLOW V trial. The company stresses that Orsiro is the first and only ultrathin drug-eluting stent to beat Xience in a randomized trial.

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

Three spine sales VPs left Amedica for Xtant Medical, which also hired two additional sales execs last week. Meanwhile, angioplasty device firm VentureMed Group hired a new CEO, and ophthalmic diagnostic firm Cassini Technologies promoted for its top spot from within.

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.

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.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Tandem Diabetes Care gained US FDA go-ahead for the first "interoperable" insulin pump.

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.

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.