US FDA’s device center in concert with third-party servicers and original equipment manufacturers are working toward consensus on how to differentiate medtech "servicing" from "remanufacturing" activities. Progress was made at a recent workshop in laying out ways that better training and more data sharing will help.

FDA is considering publishing a list of devices 510(k)-cleared based on predicates over ten-years-old to encourage companies to adopt new predicates. In a joint written response to Medtech Insight's questions, medical device regulatory experts with law firm King & Spalding said an age-based cut-off will not necessarily address the problem FDA is trying to address.

The device industry is still sorting out the implications of US FDA's recent proposals to make the agency describes as a major update to the 510(k) process. But regulatory experts say the agency's focus on finding an age-based cut-off for 510(k) predicate devices is misguided, and some argue that Congress should need to sign off on any of the floated policies.

An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.

US industry lobbyists are downplaying the practical impacts to the industry – at least so far – of the scathing report of medical malpractice, undue government influence, and questionable marketing practices published by the International Consortium of Investigative Journalists in recent weeks.

Stakeholders can still fill out a survey that asks for feedback on potential plans to retool international quality systems standard ISO 13485. The deadline for the survey was extended so the International Organization for Standardization (ISO) committee that oversees revisions to ISO 13485 can make a stronger case against opening it up for a rewrite.

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourteenth installment, former FDA investigations branch director Ricki Chase explains how device-makers can leverage publicly available data from the agency to determine where they might fall short when it comes to complying with FDA rules and regulations.

Good news for the medical device industry: After two record-setting quarters, the number of recalled products and device units fell in the third quarter of 2018. Yet device-makers are still having problems with software, which was the leading cause of recalls in Q3. Check out our Q3 recalls infographic.

Europe's biggest medtech industry and market, Germany, was in the crosshairs of the Implant Files and its ICIJ reporters, and predictably it caused a major stir. The episode has been a wake-up call for medtech, but industry hasn't let it develop into the crisis it briefly threatened to become, and is now looking beyond it and to the commercial challenges of 2019.

FDA has given Israeli company Check-Cap the green light to initiate a pilot study of its C-scan system for colorectal cancer screening.

CarThera has secured its first financial round from institutional investors to launch a pivotal trial evaluating the company's Sonocloud ultrasound therapy for patients with recurrent glioblastoma.

WhiteSwell has received $30m in financing to support development of a catheter-based device for treating acute decompensated heart failure. The investment round was led by RA Capital Management and an InCube Ventures syndicate, with participation from other investors.

Medical equipment and technology systems-maker Hill-Rom Holdings taps a former Mallinckrodt financial executive as its new chief financial officer, while promoting new VPs in Front Line Care and Strategy and Investor Relations. More personnel moves from around the medtech industry.

This week's edition of Medtech Insight's Results Recap, the weekly round-up of major device trial-results, features just one entry - long-term data from a prospective, non-randomized, single-arm anatomic and clinical evaluation of chronic refractory angina patients implanted with Neovasc's Reducer at a single medical center as part of the first-in-human clinical study in 2005. The patients treated in the trial showed sustained improvement in angina class out to 12 years and all seven Reducers implanted in the study were still patent, with no signs of strut fractures, dislocation, thrombosis, or migration.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include an endobronchial valve for emphysema approved in the US and an autologous cell therapy for urinary incontinence approved in Japan.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 3 through Dec. 9, including trial announcements from Edwards Lifesciences, Nemura Medical, Hancock Jaffe, Johnson & Johnson, and more.

Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition, covering the week of Nov. 30 – Dec. 6, includes results of a retrospective post-hoc sub-group analysis of the EF-14 phase III pivotal trial of Novocare's Optune system in newly diagnosed glioblastoma, one-year data from a study of Vieve Medical's Geneveve treatment of mild-to-moderate stress urinary incontinence, and complete results from the Long-Term Treatment Study of NeuroPace's RNS system to treat epileptic seizures.

FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.