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 require third-party servicers of devices to register with FDA, an equipment servicing company said a major downside is that registration with the agency is too costly, and that his firm and others already report adverse events to FDA.

No device-related warning letters were released by US FDA the week of June 12.

The UK IVD industry is pushing for better recognition of the value that lab tests can bring to the country's health-care system, including, for instance, in helping reduce antibiotic resistance. See what British In Vitro Diagnostic Association's Doris-Ann Williams has to say about industry's challenge here.

Diagnostics should be funded in a way that recognizes the value they bring. The UK IVD industry should also have a seat on the newly-formed Life Sciences Council. These are just two changes that would help diagnostics break through the adoption barrier in the UK and help the health-care system save "billions," say manufacturers.

While the Trump administration appears to have been partially persuaded by industry arguments that a host of China-made medtech items do not belong on a list of items earmarked for a 25% tariff starting July 6, there are still 27 devices – or accessories – that remain.

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.

By picking up the rest of Foundation Medicine, which is now valued at $5.3bn, the Swiss giant is expanding its leadership in cancer diagnostics, genomics and molecular information for personal medicine.

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.

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.

An US FDA advisory panel wasn't convinced by data for BTG/PneumRX’s Elevair Endobronchial Coil System during a June 14 meeting. The panel decided that while the emphysema device was reasonably safe, the sponsor hadn’t shown it was effective or that the benefits outweighed the risks.

Chronic obstructive pulmonary disease (COPD) is a widespread, progressive lung disease for which pulmonologists in the US have had few new treatment options available outside the standard pharmacological therapies, lung rehabilitation and high-risk lung volume reduction surgery. Now emerging technologies, in particular, endobronchial valves, which aim to shrink hyperinflated lungs in severe emphysema patients, could soon become the first minimally invasive treatment option available in the US. New study results, presented at this year's annual American Thoracic Society International Conference in San Diego, helped built momentum among US-based clinicians to extend upon their therapeutic arsenal for patients for devices that have already been widely used in Europe. This article discusses study findings presented at ATS, including a new cost-comparison analysis for treating COPD patients at home using non-invasive ventilation and oxygen therapy. We'll also discuss the latest innovative technologies for COPD patients presented at ATS and provide insights from leading experts on factors they think will drive treatment options forward.

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.