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

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.

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.

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.

Sirtex Medical has accepted the acquisition bid from the owners of CDH Genetech for Aus $33.60 per share, or $1.41bn, that was first announced in May. In January, Varian signed a deal to acquire Sirtex for Aus$28 per share ($1.28bn), but decided not to match CDH's bid, and Sirtex's board decided the higher sale price was worth the additional uncertainties that come with accepting the offer.

In this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discuss this year's trends in M&A and venture fundraising activity. They touch on what areas are getting the most interest from investors and strategic buyers, and the most recent deals worth noting.

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.

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.