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.

CMS sent guidance to state Medicaid directors on how to leverage federal funding authorities for telehealth counseling and gain reimbursement for remote monitoring programs to aid beneficiaries struggling with opioid substance abuse.

There are multiple barriers to personalized medicine development in the EU, including misaligned reimbursement policies between drugs and devices. See what attorney Riccardo Fruscalzo says about it here.

In another safety communication from US FDA on LivaNova's Stockert 3T Heater-Cooler Systems, the agency adds recommendations for providers and patients to mitigate the risk of infection from the devices used during open-chest surgery.

US FDA issued two draft guidelines June 14 addressing labeling and performance testing for guidewires and other interventional vascular devices. The draft recommendations address risks that have been identified in recent years resulting from the separation of coating material from the devices during deployment.

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.

Longtime agency investigator Laureen Geniusz reveals seven usability issues that agency investigators regularly see when inspecting medical device manufacturing facilities – troubles that could jeopardize patient safety. Her chief concern? "Human factors seems to be overlooked and not fully understood," Geniusz says.

Marseille-based Volta Medical is targeting a 2020 release for its AI software to guide cardiologists through atrial fibrillation (AF) procedures. The start-up has recently published data demonstrating the potential of its technology.

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

Rumors of a potential Stryker-Boston Scientific coupling have been quashed after the orthopedics player officially stated it is not in discussions with the cardiology company.

A trade group’s case alleging Stryker bribed doctors in Brazil has been remanded to the trial court after its dismissal was overturned on appeal. The Sixth Circuit said Stryker hadn’t proven that the case should be heard in Brazil.

Unconfirmed rumors of Stryker having approached Boston Scientific about a takeover bid raised eyebrows all around, not least because the move – reported on June 11 – was so unexpected. But would a combination of the medtech industry's No. 9 and No. 11, to create a broad-scale portfolio with very little product overlap, make strategic sense? Reactions have been mixed.

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.

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.

Sutrue Ltd. says it's working on an robotic/endoscopic suturing device that will make surgeries easier, with quicker recoveries. The current standard of care is not ideal, cardiologist Richard Trimlett, who works with the company, emphasizes here.

Clinical results from the Circulating Cell-free Genome Atlas (CCGA) trial that were presented at the American Society of Clinical Oncology Annual Meeting are positive for Grail Inc.'s genome-sequencing blood-tests. See what trial investigator Geoffrey Oxnard had to say about the findings here.