Several bills that try to lift barriers to development and use of device alternatives for pain management in response to the opioid crisis were recently approved by the US House.

US FDA says that previously identified elevated risks of type III endoleaks from endovascular aneurysm repair systems appears to be linked to a specific, no-longer-sold device, Endogix's AFX with Strata system.

There is confusion over whether it is appropriate for notified bodies to conduct “mock audits” in advance of the new EU Medical Device Regulations. Notified body executive Bassil Akra explains one reason why they can be very helpful here.

In an interview with Medtech Insight, Bayer executive Dennis Dermis described some near-misses to patient safety involving shoddy repairs to his firm's devices. The incidents convinced him that Congress needs to pass legislation requiring all third-party servicers to register with US FDA and report adverse events to the agency.

At a recent industry briefing to educate US congressional members about proposed legislation to mandate registration with FDA and reporting requirements for third-party servicers of devices, an equipment servicing company said a major downside of H.R. 2112 would be the burdens of having to register with both his business' home state and the federal agency, and that his firm and others already report adverse events to FDA.

After receiving feedback from industry and other stakeholders, FDA has revised its "working model" for its planned pre-certification program for health software. It now states that size of a company will not preclude them from participating in the program. The agency has also refined how it will conduct appraisals.

US FDA's Phil Pontikos highlights six problem areas related to contract sterilization that agency investigators routinely see when inspecting manufacturing facilities, from aging facilities to troublesome personnel, and more.

The US agency's national device expert is urging device-makers to take a hard look at their quality systems in the wake of a product recall. Phil Pontikos says firms must ask themselves "what broke down in your quality system to allow that to happen." His comments come as FDA grapples with an ever-increasing number of corrections and removals from device companies.

From cautioning against relying too heavily on a vendor's Certificates of Analysis, to advocating for more robust supplier audits, two US FDA investigators and the agency's national device expert offer device-makers advice for keeping vendors in line.

BTG ran into some serious scrutiny of its Elevair coil system for emphysema from an FDA advisory committee, which wasn't convinced the device offered a benefit that's worth the its risks. Check how physician and panel member Hugh Cassiere summarized the group's findings here.

US Patent Trial & Appeals Board Chief Judge David Ruschke has filed a wrongful termination suit against former employer Medtronic. Ruschke alleges Medtronic dismissed him due to his sexual orientation and a medical condition. The company denies the allegations.

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced June 4-10, 2018.

The Turkish government is preparing to put a significant contract for the supply of tens of thousands of advanced imaging and monitoring devices up for grabs; medtech multinationals are teaming up with local manufacturing heavyweights to increase their chances of winning this tender.

Pulmonologist Meilan Han says results from the Liberate study – the first randomized controlled trial in the US to evaluate the effectiveness and safety of Pulmonx's Zephyr endobronchial valve in patients with severe emphysema – was exciting in that the amount of improvement amongst patients was clinically significant. Check out what she said about it here.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Procept BioRobotics is seeking a unique Category I CPT code that would make it possible for its AquaBeam Aquablation device to be reimbursed at a higher rate than older prostate resection techniques. See what company founder and CEO Nikolai Aljuri said about it here.

Results of the WATER II trial confirm that Aquablation is a safe and effective treatment of benign prostate hyperplasia for large prostates, and manufacturer Procept BioRobotics is confident the procedure will eventually displace all other prostate resection techniques because it is easy for surgeons to learn.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between June 4-10, 2018, including announcements from Medtronic, MicroPort, NovoCure, and Theraclion.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Medtronic, Cook, BD and J&J are represented, along with academic and US FDA officials, on two new subcommittees formed by the National Evaluation System for health Technology Coordinating Center, which is establishing real-world evidence networks for medical devices.