PERTH, Australia – On the heels of scoring a CE mark for its Novosorb biodegradable temporizing matrix (BTM) in the EU, Melbourne-based Polynovo Ltd. crossed its first AU$2 million (US$1.3 million) month in December sales for its initial commercial product.

PARIS – Quantum Surgical SAS, of Montpellier, France, has been awarded development aid amounting to $2.25 million in grants and repayable loans from Bpifrance bank, as part of the French Deeptech program.

Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.

LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.

LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time.

PARIS – Vygon SA, of Ecouen, France, has acquired Advanced Perfusion Diagnostics SA (APD), a startup based in Lyon, France, that has developed Ikorus, a device that detects changes in visceral microvascular blood flow in the most critically ill hospital patients. Vygon did not disclose the financial details behind the agreement.

PARIS – The Syndicat National de l'Industrie des Technologies Médicales (SNITEM), the French national association of medical technology manufacturers, has just released a study looking at the development of this industrial sector in that country. This snapshot, produced every two years by the firm D&Consultants SAS on behalf of Courbevoie, France-based SNITEM and the bank Bpifrance SA, is based on a dual quantitative and qualitative approach.

U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation.

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea.

DUBLIN – Meda AB’s acquisition in 2014 of the veteran Italian specialty pharma firm Rottapharm generated a €1.975 billion (US$2.2 billion) payday for the latter firm’s owners, the Rovati family. A small fraction of that amount is now being recycled into a new investment initiative, Aurora Science, which is a three-way partnership among Monza-based Rottapharm Biotech Srl (the R&D arm of the company that was not part of the Meda transaction), the Milan-based specialty pharma Italfarmaco SpA and Aurora-TT Srl, a Milan-based commercial technology transfer company.