When it comes to opioids and enforcement, the US Department of Justice is largely focused on the drug side. But Gibson Dunn attorney Jonathan Phillips says that doesn’t mean device-makers should be complacent about opioid enforcement activities. See what he said here.

US FDA announced the approval of the first direct-to-consumer mobile medical app that can prevent pregnancy via fertility awareness tracking. The app, Natural Cycles, has been criticized in Europe after some users experienced unplanned pregnancies. On the same day, the agency approved the first contraceptive vaginal ring that can be reused for an entire year.

Following an extension for Unique Device Identifier requirements for low-risk devices earlier this summer, US FDA has pushed back a deadline to input UDI date into its GUDID database for combination products that go through the drug center. Manufacturers, however, are still required to implement UDIs labeling by Sept. 24.

The US Medicare agency in its final 2019 Inpatient Prospective Payment System rule plans to continue assessing patients’ outcomes under its Hospital Value-Based Program in part with a Medicare spending per beneficiary measure, despite industry warnings that doing so may sacrifice patient quality of care.

US FDA's new Oncology Center for Excellence brought in key experts to help review and approve Endomag's new Magtrace and Sentimag System combination product to help surgeons trace and remove breast tumors. The case highlights how disease-specific centers could change the way the agency reviews products, and it also spotlights the agency's recent efforts to improve combination product reviews. Check out our Q&A with FDA's Binita Asher.

A record 360 recall events were initiated by device-makers in the second quarter of 2018, beating the previous high of 343 product recalls recorded in Q1. On a somewhat brighter note, the number of device units recalled in Q2 fell a whopping 80% from the prior quarter. Check out our Q2 recalls infographic.

A letter from DITTA Chair Patrick Hope to a US FDA point person for MDSAP highlights concerns some device-makers have about the flourishing Medical Device Single Audit Program, including inconsistent auditing approaches from facility to facility, and long-delayed audit results and MDSAP certificates.

Device-makers have given a collective shrug to US FDA's Premarket Approval Critical-to-Quality (PMA CtQ) pilot program, a Case for Quality initiative that aims to identify "critical-to-quality" attributes for an array of products and ensure that quality is built into devices at their earliest stages. Since the pilot began in September 2017, no firms have enrolled. FDA's Bleta Vuniqi surmises that the empty pilot might be a victim of a glut of FDA pilot programs. Meanwhile, the agency has been talking internally about ways that the fledgling PMA CtQ pilot could be absorbed by FDA's burgeoning CMMI maturity model pilot.

The UK is unmistakeably in the period of the calm before the storm, and an enforced Brexit lull is in place. But the thoughts of UK and EU decision-makers – and UK medtech companies – are not straying too far from the upcoming trade deal negotiations and the business of making the best of Brexit, however and whenever it manifests itself.

Digital Health company Profusa raised more than $45m in a series C financing round. The company plans to use the proceeds to bring its tiny CE-marked injectable biosensors, used to monitor tissue oxygenation in patients with peripheral artery disease, to key opinion leaders and clinicians in Europe.

Richmond, Calif.-based exoskeleton company Ekso Bionics named Jack Glenn as chief financial officer.

Liquid biopsy developer Laboratory for Advanced Medicine (LAM) named Jinjie Hu as chief regulatory officer.

Global medtech player Becton Dickinson recently wrapped up an all-cash deal to acquire TVA Medical, which makes an endovascular arteriovenous (AV) fistula creation technology called the everlinQ endoAVF System. See what Steve Williamson, BD's president of Peripheral Intervention, said about it here.

US FDA cleared the gammaCore Sapphire non-invasive vagus nerve stimulator for the acute treatment of pain associated with migraine and episodic cluster headache. Electrocore also recently signed a deal with UpScript to provide a direct-to-patient sales channel for gammaCore.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, a new microstent for glaucoma was approved by US FDA.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Aug. 6 through 12, including trial announcements from Hancock Jaffe, Medtronic, and LivaNova.

PRELUDE feasibility study of LivaNova's Caisson transseptal transcatheter mitral valve replacement (TMVR) system is complete and the company the INTERLUDE CE Mark trial has begun, the company announced. The company is now working with the US FDA to finalize the protocol for the ENSEMBLE US pivotal trial.

Active Implants is ramping up for a 2019 commercial launch of its NUsurface polycarbonate-urethane meniscus implant as it continues clinical trials in the US. The firm hopes to earn US approval for the device by the end of 2020. See what Active Implants CEO Ted Davis said about it here.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, EU and Australia approvals for Baxter's new infusion system, and more.

Active Implants announced the completion of patient enrollment in the VENUS randomized trial of the NUsurface meniscus implant for the treatment of persistent knee pain caused by injured or deteriorated meniscus tissue. VENUS is designed to support a de novo clearance from US FDA, which would make it the first artificial meniscus approved in the US. NUsurface already has a CE mark and the company is planning to start a limited commercial release outside the US in 2019.