LONDON – Kaia Health Software GmbH closed an $8 million funding round that it will use to accelerate U.S. commercialization of its digital health apps for managing musculoskeletal disorders and chronic obstructive pulmonary disease (COPD).
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 – 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.