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.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
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.
PARIS – White Fund SA, of Lièges, Belgium, secured $22 million for early stage financing of Belgian med-tech companies. “Our shareholders are investing in a specialized fund [that], beyond financial returns, [creates] expectations in terms of supporting the strong med-tech ecosystem in Belgium and advantages in terms of job creation,” explained Benoît Fellin, investment manager at Noshaq SA, manager of the White Fund.
LONDON – Sequana Medical NV has raised €19 million (US$21 million) in a private placing to fund continuation of the U.S. pivotal trial of its Alfapump in treating ascites due to cirrhosis of the liver and a European trial of the device in heart failure patients who have stopped responding to diuretics.