The 2.3% medical device tax is a thing of the past, and now Medicare coverage is one of the issues that is front and center for the Medical Device Manufacturers Association. MDMA President and CEO Mark Leahey told BioWorld also that while member companies are keen on regulatory harmonization, the struggles in standing up the new European regulatory framework is a far more pressing concern.

SEATTLE – As it enters its third year, the Human Cell Atlas project has mapped 100 million of 100 billion cells, and by comparing gene expression profiles of normal and aberrant cells and building networks of cellular interactions, is leading to breakthroughs in understanding of disease at a molecular level.

LONDON – Consumer smartphone apps that use image processing algorithms to assess and monitor potentially cancerous skin lesions have not been properly tested in clinical trials and cannot be relied on to produce accurate results, according to a systematic review of published studies.

PARIS – Sensome SAS, of Palaiseau, France, has closed a second funding round, of $9 million, with its original French investors (Kurma Partners SA, Invest Partners SA, BNP Paribas Développement SA and the Paris-Saclay Seed Fund), now joined by the Japanese-based Asahi Intecc Co. Ltd.

As the deadly coronavirus continues to spread, countries around the world are scrambling to understand the public health threat and identify and quarantine people who may be infected. To that end, Novacyt SA has launched a molecular test that detects only the 2019 strain of the coronavirus, reducing the chance of false diagnoses.

LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.

Medtronic plc has gained CE mark approval for its Cobalt and Crome portfolio, the company’s first implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) to offer connected health via Bluesync technology. The portfolio will be rolled out on a country-by-country basis throughout Europe, with initial implants in select countries to begin soon.

PARIS – The European mammography division of GE Healthcare Inc., based in Buc, France, has just performed the first breast biopsy guided by angiomammography, using the Pristina Serena biopsy robot on a patient at the Gustave Roussy Institute in Villejuif, France.

Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.