LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.

Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.

Medtronic plc reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8% as reported and 1.5% on an organic basis. Analysts noted, however, that the figure beat the consensus of $7.08 billion. It also exceeded Wells Fargo’s $7.12 billion estimate. With the continued uncertainty related to the ongoing COVID-19 pandemic, the Dublin-based company did not provide formal annual or quarterly financial guidance. Still, the need for ventilators pushed the company ahead.

PARIS – Carmat SA has closed an $11.8 million loan in the form of a government-backed loan from a French banking syndicate. In an environment made uncertain by the COVID-19 crisis, Carmat will be able to continue its clinical development program on its total artificial heart, undisturbed. “This financing facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021,” Stéphane Piat, CEO of Carmat, told BioWorld.

PARIS – Ganymed Robotics SAS reported the successful completion of functional prototype testing for its surgical robotic assistant used in total knee arthroplasty. According to a systematic review of the literature, published in the Journal of Arthroplasty, more than 2 million patients undergo knee arthroplasty each year after suffering arthritis of the knee.

DUBLIN – Synox Therapeutics Ltd., a spin-out from Celleron Therapeutics Ltd., has raised €37 million (US$43.7 million) in a series A round to conduct a pivotal trial of emactuzumab, an antibody its parent company in-licensed from Roche Holding AG in August.

The European Commission has awarded the CE mark to Hologic Inc. for its Genius Digital Diagnostics system for cervical cancer screening. According to the company, it is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to assist cytotechnologists and pathologists in detecting precancerous lesions and malignant cells in women.

PARIS – Esight Corp. is starting distribution of its newest low-vision assistive technology in France, Germany and the U.K. The latest version of the technology, the Esight 4, was designed to be more versatile and mobile than before, has double the display brightness and has improved the auto-focus function, according to the company.

LONDON – A second phase III trial of Johnson & Johnson’s adenoviral-vectored COVID-19 vaccine is starting in the U.K. this week, amid concerns the positive news from the Pfizer Inc./Biontech SE vaccine study will deter volunteers from coming forward to take part.