PARIS – Braintale SAS, of Paris, has gained CE mark approval for Brainquant. This software platform, which uses DICOM radiology imaging, enables diffusion MRI scans to be processed as part of managing patients in a coma following brain injury.
Siemens Healthineers AG expects to have a total antibody test available in late May 2020 to identify individuals exposed to the SARS-CoV-2 virus that causes COVID-19. The rapid diagnostic test detects IgM as well as IgG and other antibodies in the blood.
LONDON – A veteran of the European vaccines industry has brought together three companies in three countries, in what is described as an ultra-fast-track COVID-19 vaccine development program. From a standing start less than three months ago, the three biotechs, Reithera Srl in Rome, Leukocare AG in Munich, Germany, and Univercells SA in Brussels, Belgium, have advanced to GMP manufacturing, with first-in-human studies due to start in June.
DUBLIN – The Swiss biotech sector raised about CHF1.2 billion ($$1.2 billion) in equity investment in 2019, a significant downward dip on the last two years, but well ahead of its average annual raise of CHF800 million over the past decade, according to the newly published Swiss Biotech Report 2020.
LONDON – The European Parliament gave its full backing to the emergency measure to delay the Medical Device Regulation (MDR), voting by 693 to 1 in favor of postponing implementation from May 26 this year, to May 26, 2021. The delay will “allow health authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic” by keeping existing procedures in place, the parliament said in a statement.
LONDON – The U.K. treasury announced a £500 million (US$622.5 million) COVID-19 bailout plan for research-based startups, which could see the government holding equity stakes in venture capital-backed firms.
PARIS – The French Association of CROs (AFCROs) has published the third edition of its survey of clinical research in France. This tool is intended to provide an overview of clinical research in that country, along with any recent developments.
LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic.
PARIS – Medical gases specialists Air Liquide SA, of Paris, along with Peugeot SA, Schneider Electric SE and Valeo SA have joined together in a consortium to manufacture ventilators in a time when there is a critical shortage.
Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.