The US FDA is floating eight categories of device accessories for low-risk, class I designation as part of its shift to addressing classification of accessories separately from "parent" devices. It also clarifies its approach to orthopedic instruments.

New US FDA draft guidance attempts to clarify when and why the agency might deny device manufacturers an export certificate, as well as the review process to appeal such denials.

There are calls for an independent watchdog group to facilitate implementation of the EU Medical Device Regulation. Combination products expert Janine Jamieson explains one potential benefit of such a group here.

The EU medtech sector needs an independent watchdog group to help analyze the impact of the jerky steps toward implementation and head off potential crises, three experts tell Medtech Insight.

Canadian authorities are requiring new performance data to demonstrate the accuracy of some infusion pumps.

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.

Device manufacturer Maquet has agreed to settle a lawsuit brought after a patient died when one of the company’s blood oxygenation devices broke.

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.

The American Society of Pain and Neuroscience is teaming up with Ethos Laboratories to investigate the relationship of urine-measured biomarkers with pain interventions. See what ASPN President Dawood Sayed said about it here.

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

The worldwide liquid biopsy market is expected to reach $2.0bn by 2022, according to a new report by Meddevicetracker, "Oncology: Liquid Biopsy Products." The growth is driven by the rising global incidence of cancers, which, in turn, fuels innovation among companies to develop noninvasive diagnostic assays that obviate the need for tissue biopsy. This is the first in a two-part series providing an overview of the liquid biopsy market, as well as the technologies developed by the larger players in this space, and examining the biggest barriers and growth drivers. In the second part, we'll take a closer look at emerging companies in the sector and offer key insights from C-level attendees at the recent Liquid Biopsy Conference in San Francisco.

Kevin Brown, physicist and global VP of scientific research for device-maker Elekta, says his company has rejected some product ideas because they ultimately wouldn't be profitable. See what he said here.

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.

Hindsight 20/20 is a Q&A feature where veterans of the medtech industry share career highlights, specific achievements and hurdles they have faced. In this installment, Kevin Brown, global VP of scientific research at radiation therapy specialist Elekta, discusses the challenges of translating scientific ideas into breakthrough technologies that bring value to clinicians and patients. He also addresses his guiding principles for picking winning ideas and his journey bringing to market the world's first integrated MRI and radiotherapy system.

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.