The European Commission needs to be faster and more efficient in its implementation of the new EU Medical Device Regulation (MDR), say German manufacturers, watching the remaining months of transition time slip into single figures. A few economic operators have come clean about the pressure the MDR has brought to bear, but the suspicion is that many are choosing to keep quiet.   

Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.

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

June Raine has agreed to lead the Medicines and Healthcare products Regulatory Agency temporarily after the agency’s incumbent chief executive steps down in September.

There are now four notified bodies designated under the new EU Medical Device Regulation. But that is not enough, and new designations do not mean immediate testing either.

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.

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.

Roche Diagnostics Corp. is moving closer to realizing its vision of personalized health care through partnerships and applying machine learning and data sourcing. See what Rod Cotton, Roche Diagnostics' senior VP of commercial operations, said about it here.

The medtech giant reported revenue of $7.5bn in the quarter that ended on 26 July, up 3.5% year-over-year basis, led by 12.5% growth in revenues from emerging markets. Medtronic’s fastest-growing business is its brain therapies unit, which reported 11.4% growth in the quarter.

In vitro testing company Accelerate Diagnostics fills COO slot; remote medical technology firm BioTelemetry appoints a CMO; a new chief executive is in place at medical measuring instruments-maker Revenio Group; and more.

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. 

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.