A new update to the pre-market cybersecurity guidance issued four years ago reflects how US FDA's thinking on the issue has evolved, as more cases of device vulnerabilities have surfaced. Among the key updates are recommendations for sponsors to submit a cybersecurity "bill of materials" in product labeling to better coordinate with end-users and to use a two-tiered risk management approach.

No device-related warning letters were released by US FDA the week of Oct. 17.

The US Centers for Medicare and Medicaid Services will hold a town hall in early December to discuss FY 2020 applications for new add-on payments for technologies under the hospital inpatient prospective payment system.

The latest compensation survey by the Regulatory Affairs Professionals Society provides some salary benchmarks, as well as data on factors influencing the job market globally, and other noteworthy stats on the sector.

Medtech Insight senior reporters Ferdous Al-Faruque and Sue Darcey talk about how the upcoming US midterm elections could shake things up for the medical device industry in this week’s podcast.

US FDA hasn't posted a device-related close-out letter online in five months. Agency spokeswoman Deborah Kotz says firms were "issued" close-outs over the past six months – they just haven't been posted online yet. But a firm being "issued" a close-out letter isn't the same as having FDA publicly announce it online for the world to see – which, one could argue, is the whole reason behind the close-out program in the first place. See what else Kotz said here.

Medical device manufacturers under the dark cloud of a US FDA warning letter work hard to close them out, and, importantly, receive a close-out letter from the agency that is posted online for everyone to see. Yet FDA hasn't publicly released such a missive to device companies since May – the longest gap since the close-out program began in 2010. FDA says it's aware of the problem.

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging.

The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

Royal Philips has launched a global artificial intelligence collaboration program with start-up companies that will allow innovators in the area to work with the group's global innovation hubs. The company is looking to build and scale promising ideas and consider them for further collaboration.

The study will evaluate Zimmer Biomet's mymobility app on the Apple Watch and iPhone to guide patients undergoing knee or hip surgery through both pre- and post-op care.

Recent moves up the ladder: new COOs at Beckton Dickinson and Abbott, a chief technology officer at LuxCath, and a chief growth officer at Varian Medical. In addition, the chairman of BTG announced his decision to depart at the end of the year.

The company's device business chief is expanding his portfolio as Abbott's new president and chief operating officer, leading to some speculation that he is being positioned to be the next CEO.

Diagnostic developers may face a narrowing path to get patent protection in the wake of court determinations that "fundamental laws of nature" aren’t patentable. Some legal observers advocate carefully deploying trade secrets to bridge the gap. See what attorney Joshua Stowell said about it here.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the four added this week, Tandem Diabetes and Medtronic both gained integrated insulin pump system approvals in Canada.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Oct. 8 through Oct. 14, including trial announcements from Abbott Laboratories, Medtronic, Edwards Lifesciences, Carag AG, DJO Global, RTI Surgical, and Terumo.

The surgeon and serial device inventor has been getting Johnson & Johnson's Center for Device Innovation off the ground this year on the vast Texas Medical Center complex, and he says it's like nothing he has ever experienced.

Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here's an infographic to spotlight US device approval trends during the third quarter, July through September.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A smart contact lens, self-fitting hearing aid and laser eye surgery device are among the new additions to the tracker.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Oct. 1 through Oct. 7, including trial announcements from Apollo Endosurgery, SPR Therapeutics, Endologix, and EPIX Therapeutics.