The US FDA released one close-out letter in September, resolving a warning issued to a California device firm in 2017.

Med Pen Concepts LLC was the only recipient of a device-related warning letter from the US Food and Drug Administration last month.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-two documents have been posted on the tracker since its last update.

Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.

Congress extended the Small Business Innovation Research and Small Business Technology Transfer programs, right before they were set to expire on 30 September.

The US Food and Drug Administration and the Veterans Health Administration are partnering to create tools that can help novel technology reach patients more quickly and easily.

The US FDA released one close-out letter in September, resolving a warning issued to a California device firm in 2017.

Med Pen Concepts LLC was the only recipient of a device-related warning letter from the US Food and Drug Administration last month.

Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.

PocDoc and Lifelight have won the Novartis’ Heart Health Catalyst program and will work on smartphone-based lipid-measuring and clinical vital signs tools for evaluating cardiac health on a population level.

This edition of Medtech Insight’s regular round-up of heart-tech news covers some highlights of this years’ Transcatheter Cardiovascular Therapeutics (TCT) meeting in September, including the latest trials of Abbott's Amulet left-atrial appendage closure device and Medtronic's Intrepid transcatheter mitral valve replacement.

The company has enrolled the first patient in the second human trial of its implantable metabolite monitoring system, which it expects could change the game for blood glucose measurement.

The US FDA has approved additional indications for Thermo Fisher Scientific’s Oncomine Dx Target, allowing the companion diagnostic to be used to detect more varieties of lung and thyroid cancer.

Start-up Esper Bionics has designed a prosthetic hand that can anticipate a user’s actions, changing the game for amputees.

In a panel discussion at the TCT conference in Boston and in a recently published report, Jonathan Norris of Silicon Valley Bank explained why health care investment has slowed this year, and why remaining pragmatic and optimistic is important moving forward.

The CDC’s $90m funding will be split among five laborites across the US over five years as a part of its pioneering Pathogen Genomics Centers of Excellence Network.

As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.

Smith + Nephew is expanding its suite of simulation technologies to train surgeons on new techniques before they enter the operating room.

The FDA granted 510(k) clearance to Applied Tissue Technologies for its non-foam negative pressure wound therapy system. 

A CDC study found that fewer than half of children with sickle cell disease were getting screened for strokes, and fewer than 40% of children were taking recommended medications.  

Results of the CLASP IID trial showed Edwards’ Pascal mitral valve repair system was non-inferior for safety and effectiveness compared to Abbott’s MitraClip device.