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.
Oncomfort SA finalized a €10 million (US$11.8 million) series A fundraising round to further develop its Digital Sedation product and pursue international expansion. Debiopharm and Crédit Mutuel Innovation led the round with participation from Wallonia Innovation and Growth and previous investors.
The Lifetime Initiative released a roadmap to revolutionize health care in Europe by implementing cell-based interceptive medicine in a perspective article published Sept. 7 in Nature.
Spanish researchers developed a new artificial pancreas system that maintained blood glucose levels in individuals with type 1 diabetes mellitus (T1D) during and following heavy physical exercise. Results of the small study were published in the Endocrine Society’s Journal of Endocrinology & Metabolism.
As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.
The Court of Justice for the European Union (CJEU) has invalidated the EU-U.S. Privacy Shield, a mechanism designed to ensure the privacy of EU citizens’ data when conveyed to other nations in a manner consistent with the EU’s General Data Protection Regulation (GDPR). Makers of drugs and devices are not without recourse in transferring patient data to the U.S. for clinical trials conducted in Europe, but industry must revisit their standard contractual clauses to ensure those protocols provide the necessary privacy provisions, or face fines that could amount to tens of millions of euros.
Medtronic plc reported first-quarter worldwide revenue of just over $6.5 billion, a decrease of 13% as reported. As Cowen’s Josh Jennings wrote, the company’s results were better than expected, with an organic revenue growth decline of 17% vs. the Street’s prediction of a 25% decrease.
PARIS – Curadigm SAS has raised $1 million in non-dilutive funding from Bpifrance (Banque publique d’investissement in France), for development of its Nanoprimer technology. Bpifrance’s Deep Tech program in France recognizes health tech companies with breakthrough innovation and strong commercial potential.
RSS
