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.

A new "rolling plan" provides deadlines for implementing actions, and other efforts, that are necessary to get the new EU Medical Device and IVD Regulations off the ground.

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

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

NeuroDiagnostics LLC said its investigational Alzheimer's disease test had been designated by US FDA as a Breakthrough Device. This is at least the third company to achieve that recognition for technology targeting Alzheimer's this year.

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.

The up-to-10 million diabetics in Germany could benefit from a more optimal combination of digital tools and conventional case to maintain glucose control, say local IVD companies. But the industry is still waiting on the promised National Diabetes Strategy, while the government talks about more reimbursement support for innovation.

Medtech Insight talked to Rachel Shelly, the Head of Medical Technologies for IDA Ireland, about the Irish government's continuing efforts to attract medtech companies, the implications of Brexit, and the growing emphasis on data-analytics within the medtech industry in Ireland.

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.

Following a fresh injection of funding, Sequana Medical is gearing up to grow its European business and begin a pivotal US study for alfapump, its implantable, automated pump for the continual removal of ascites. The Belgian company is positioning itself as a key player in the growing liver disease treatment market.

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.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the additions, Abbott's HeartMate 3 left ventricular assist device gained "destination therapy" approval from US FDA, meaning its now vetted for use in patients who are not eligible for a heart transplant.

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.

Temple, Texas, is not the first place that comes to mind as a medtech industry hotspot, but the small city wants to be the anchor of a "medtech triangle" in central Texas. It currently boasts the 5,000-square foot Temple Health and Bioscience District facility with space, equipment, guidance and networking opportunities for medtech start-ups. The hope is it will grow and attract investment and more high-paying jobs.

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.