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.

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.

Danish device-maker Ambu has agreed to pay $3.3m to resolve allegations of False Claims Act violations. The company is said to have made medical product in Malaysia and China for sale to the Departments of Defense and Veterans Affairs, which is forbidden under the Trade Agreements Act.

Over the past few years, the US FDA has been pulling enforcement punches, relying more on holding face-to-face regulatory meetings than firing off warning letters. See what FDA Compliance Branch director Melissa Michurski said about the meetings here.

The official designation of a notified body in the European Commission’s Nando database is the trigger for that notified body to begin testing. But can manufacturers expect immediate service from DEKRA?

The medical device industry is eager to explore regulatory proposals to introduce Unique Device Identification (UDI) in Australia. However, when it comes to implementation of a system, medtech firms claim they should be given enough time to clear non-UDI-compliant products from their inventory in distribution channels.

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.

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.

AtriCure Inc. has closed a $300m structured deal to acquire SentreHEART Inc., a privately held developer of percutaneous left atrial appendage management solutions.

Genomic profiling firm Foundation Medicine snags top Roche Genentech cancer researcher as new CSO; OneOme, a health-care tech company, hires new CEO; Insulet and Quanterix hire new directors; and more.

At this year's AACC conference, Medtech Insight caught up with Siemens Healthineers' president of laboratory diagnostics Deepak Nath. See what Healthineers' Nath said about plans for their flagship Atellica solution here.

At this year's AACC annual conference, Medtech Insight sat down with Siemens Healthineers' president of laboratory diagnostics, Deepak Nath, to learn about plans for their flagship Atellica platform including the new Asa tablet, introduced at this year's show. 

Siemens Healthineers AG has signed a billion-dollar deal to merge with US firm Corindus Vascular Robotics, expanding the German company's advanced therapies business.

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.