The Medical Device Control Office is to launch a trial program for expediting the approval of certain classes of medical devices.

As principal deputy commissioner of the FDA, Amy Abernethy is focused on developing overarching policies that affect all its product centers. But perhaps what will stand as her legacy is her work to develop a data-centered strategy to improve how the agency reviews products and ensures their long-term safety and efficacy.

While the push for transparency was uppermost in the mind of the European Commission when it drafted the new Medical Device Regulation, the way we are learning about new notified bodies is far from transparent.

Ten key take-home messages from recent interviews with recruitment expert Elena Kyria on the impact of the new medical device regulations on recruitment in the EU. This is the third and final installment of the first part of an ongoing series of articles on this topic. The second series will begin in September. 

The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.

EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

A maker of medical equipment, health-care supplies, and radiation products used for general and plastic surgery was cited for quality systems violations in the only device-related warning letter released by the US FDA this week.

Will medical devices be among the next sectors to feature in the EU/US MRA? The EU has put forward suggestions on how to do device trade with the US through building regulatory co-operation.

While Medtronic PLC's Brain Therapies business was by far the fastest-growing unit in the first quarter of fiscal 2020, sales of spine surgery products grew faster in the first quarter than they have in nine quarters. See what Medtronic's CEO Omar Ishrak said about it here.

The largest diagnostics companies, including Roche Diagnostics Corp., showcased their latest products at the recent American Association for Clinical Chemistry's (AACC) conference in Anaheim. See what David Smith, regional business manager for Roche's Navify decision-support portfolio, said about it here.

Medtronic and the nonprofit health plan Capital District Physicians' Health Plan Inc. (CDPHP) announced they'll be collaborating on an outcomes-based agreement for diabetes patients using Medtronic's insulin pumps. See what Suzanne Winter, VP of Medtronic's Diabetes Group said about it here.

The recent AACC annual meeting drew more than 20,000 laboratory professionals to the Anaheim Convention Center. Medtech Insight caught up with the leading companies in the diagnostics space for a roundup of their latest product offerings and new developments. 

Health plan members will be invited to join Medtronic’s Inner Circle patient engagement program, which applies game design to help motivate and encourage patients with diabetes to achieve monthly health-outcome goals.

AtriCure Inc. has closed a $300m structured deal to acquire SentreHEART Inc., the privately held developer of the Lariat percutaneous left atrial appendage (LAA) closure device. See what AtriCure CEO Michael Carrel said about it here.

As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.

Results of the SENSE trial showed Biotronik’s DX system, which is available in both ICD and CRT-D devices, can detect atrial high-rate episodes as effectively as dual-chamber ICDs and better than single-chamber ICDs even though it does not have an atrial sensing lead.

In this edition of Device Week, Medtech Insight managing editor Marion Webb reports on her discussions with diagnostic company executives at the recent American Association for Clinical Chemistry meeting in Anaheim. And senior reporter Catherine Longworth previews her feature on MDisrupt, a new company that touts itself as the world’s first medical diligence company for the healthcare industry.

UK-based liquid biopsy company Angle PLC is expecting to make a landmark regulatory submission to the US Food and Drug Administration early in the fourth quarter of 2019 for Parsortix, which aims to detect and capture circulating tumor cells in cancer patients. See what Angle's CEO, Andrew Newland, said about it here.

Andy Kach, a principal in ZS's Medical Products and Services practice, offers his perspective on the “war of the robots” in the surgical technology market. He argues that companies that focus on specialized, expensive technologies will eventually cede market share to systems that are multifunctional, portable, and valuable to multiple surgical departments.

An overview of the global medical device approvals in July, as captured by Medtech Insight's Approvals Tracker.