Imaging equipment firms and other device-makers are lobbying Congress for more FDA controls over companies that perform third-party maintanence of the equipment. Bayer executive Dennis Durmis describes one instance of sub-par maintanence performed on one of his firm's devices here.

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 Durmis 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.

The Medicines and Healthcare products Regulatory Agency explains which symptom checkers are likely to be medical devices.

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.

Sandra Peterson is retiring as worldwide chairman of J&J after about five years in the post; several other executives moved up in the ranks.

A Massachusetts jury has ruled that Boston Scientific is not at fault for adverse events experienced by a woman implanted with the company’s pelvic mesh products. This is the third time that juries in the state have ruled in favor of the company in an ongoing series of suits.

Siemens Healthineers is introducing a new ultrasound system, the Acuson Sequoia, which has been developed to enable high-resolution imaging at greater depths for patients with larger body types.

Roche bought out Foundation Medicine in full. Check out what Datamonitor Health analyst Amanda Micklus says about how the deal fits with Roche's current M&A strategy.

In a move to accelerate adoption of its AI-driven genomics platform, SOPHiA Genetics has acquired Interactive Biosoftware, the French developer of Alamut, a clinical decision support software used in  genomic data interpretation. 

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.

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.