According to the Swiss association for medical technology companies, Swiss Medtech, introducing the new European regulations for medical devices (MDR) and in vitro diagnostics (IVDR) is going to have serious consequences for the sector in Switzerland. This Swiss trade association has just published its biannual survey as part of the 2020 sector study on the Swiss medical technology industry (SMTI).
LONDON – Sleep disorder specialist Nyxoah SA hit the top end of its price range of €17 per share, raising €84.75 million (US$100) million in its initial public offering. Assuming full exercise of the over-allotment option, the company will have a market capitalization of €375.26 million. The shares began trading on Euronext Brussels (EBR:NYXH) on Sept. 18, and had a good first day, closing up 14.7%, at €19.50.
PARIS – Soon, a machine, as quick and simple as a breathalyzer, could be used to detect COVID-19 from molecules present in exhaled air. The research team from Institut de recherches sur la catalyse et l’environnement de Lyon (IRCELYON – Lyon Institute for Research on Catalysis and the Environment) is investigating the analysis of volatile organic compounds (VOCs) found in exhaled breath for COVID-19 detection.
LONDON – After years of progressing at snail’s pace, COVID-19 has forced through a rapid adoption of digital tools across the spectrum of health in the U.K., from general practitioner appointments, to hospital referrals, elderly care homes and community nursing. “At game changing speed” the health and care system, “has gone from one extreme to another,” said Harpreet Sood, a general practitioner in inner city London and board member of Digitalhealth London.
LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.
Siemens Healthineers AG snagged a key role in the mystery playing out across the world's pandemic stage – what do antibody test results mean in terms of immunity to SARS-CoV-2 and how do different tests assessing different proteins compare? The U.S. CDC and the Joint Research Centre (JRC) of the European Commission tapped the Erlanger, Germany-based company to take the lead in developing a process to standardize antibody assays.
LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.
LONDON – With just four months to go until Brexit is activated, the start of September finally saw the med-tech industry get official guidance on the licensing regime for medical devices in the U.K. once the Medicines and Healthcare Products Agency (MHRA) becomes the standalone regulator Jan. 1, 2021.
PARIS – For the past three years, French health care establishments, hospitals, radiotherapy centers and medical biology laboratories have had to report any security incidents affecting their IT systems. The French national agency for digital health care (ANS) has just released its latest annual report.
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