HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).

LONDON – Cmr Surgical Ltd. has again broken the record for a private financing round for a European med-tech company, raising £195 million (US$240 million) in a series C that will fund global commercialization of its portable robotic surgery system, Versius. Since the record-breaking series B in May 2018, when it raised $100 million, Cmr has set up offices in four continents and completed 30 first-in-human procedures. Currently, there are no commercial users, but the company now employs more than 400 people.

LONDON – 4BIO Capital announced the first close of its second fund at $50 million, to be exclusively invested in advanced therapies, including cell and gene therapies, RNA drugs that silence or activate genes, oncolytic vaccines and the microbiome.

Shares of San Diego-based Cidara Therapeutics Inc. (NASDAQ:CDTX) enjoyed a skyward ride, closing Tuesday at $2.35, up 67 cents, or 40%, on word of a deal with Mundipharma International Ltd., of Cambridge, U.K., to develop and commercialize rezafungin for invasive fungal infections. "Historically, [antifungal] pricing has been much stronger in the EU, so that is an important opportunity for us and now for Mundipharma as well," Cidara CEO Jeffrey Stein said.

LONDON – France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has published draft guidelines on the cybersecurity of medical devices, becoming the first national regulator in Europe to specify what manufacturers should do to protect devices against malicious attacks.