PARIS – Quantum Surgical SAS has closed $48 million in funding to finance the commercial launch of its integrated robotics platform for percutaneous treatment in liver cancer. The round was led by Hong Kong-based Ally Bridge Group who invested $24 million, or half the total amount raised. Three banks also participated in this funding round: The European Investment Bank, Bpifrance and Caisse d’Epargne Languedoc Roussillon.

PARIS – The French National Authority for Health (HAS) is expanding the available range of novel autologous technologies reimbursed in the context of breast reconstruction following ablative surgery. In doing so, the HAS is paving the way towards reimbursement for novel autologous techniques in general.

DUBLIN – Sofinnova Partners closed out its flagship Capital X fund at €472 million (US$550 million), providing further evidence that private equity investing in European biotechnology and medical technology remains in rude health. It represents, managing partner Graziano Seghezzi told BioWorld, one of the most successful fundraising campaigns in its 30-year history. “We went out and raised this fund in six months.”

PARIS – Teams from the Pitié-Salpêtrière hospital, the Institute for Research in Development, Sorbonne University and the National Institute of Health and Medical Research are proposing a new technique that uses artificial intelligence (AI) to identify the risk of developing a type of cardiac arrhythmia called Torsades de pointes (TdP) associated with taking certain drugs.

The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.

The Scottish government has signed a deal with digital therapeutics company Big Health Inc. to make a cognitive behavior therapy (CBT) platform for anxiety and insomnia available through the NHS. It makes Scotland the first country to provide a digital therapeutic for anxiety and insomnia nationally.

Medtronic plc’s Hugo robotic-assisted surgery system has received a CE mark for urologic and gynecologic procedures, paving the way for commercialization in Europe. The approval is a key milestone for the Dublin-headquartered company, following the launch of Hugo in Latin America and India. The company is prioritizing robotics as a major growth opportunity, but will face tough competition in the space as it goes head-to-head with established market leader Intuitive Surgical Inc. According to Medtronic, Europe could provide a significant opportunity due to its current low uptake of surgical robotic procedures.

Mindmaze SA raised $125 million in a debt financing round led by Albacore Capital Group to expand its virtual reality-based digital neurotherapeutics platform. Total funding for Mindmaze now exceeds $235.7 million to date. Investors include the Hinduja Group, Venture Kick, the Foundation for Technological Innovation, and Leonardo DiCaprio. The Mindmaze platform assesses and restores cognitive and motor function in individuals who have sustained neural injuries or impairment from degeneration and aging.

Calpro AS and Ampersand Health Ltd. are combining technologies to provide a self-management and remote monitoring solution for people with inflammatory bowel disease (IBD). The partnership will integrate Oslo, Norway-based Calpro’s smart biomarker test with Ampersand’s digital therapeutic app My IBD Care. The companies said the collaboration could help reduce the administrative burden of IBD patient care.

Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification. Rather than provide a list of risk classes for specific device types, the guidance provides a framework by which the manufacturer does its own evaluation of the inherent risk of the device, opening the door to disagreements between the manufacturer and its notified body.