Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.

PARIS – White Fund SA, of Lièges, Belgium, secured $22 million for early stage financing of Belgian med-tech companies. “Our shareholders are investing in a specialized fund [that], beyond financial returns, [creates] expectations in terms of supporting the strong med-tech ecosystem in Belgium and advantages in terms of job creation,” explained Benoît Fellin, investment manager at Noshaq SA, manager of the White Fund.

LONDON – Sequana Medical NV has raised €19 million (US$21 million) in a private placing to fund continuation of the U.S. pivotal trial of its Alfapump in treating ascites due to cirrhosis of the liver and a European trial of the device in heart failure patients who have stopped responding to diuretics.

PARIS – EY SAS has published the results of the first edition of a barometer dedicated to the role of artificial intelligence (AI) in French public hospitals. The health care sector, which is undergoing wholesale change in France, is suffering tight economic constraints and faces ever-increasing expectations from patients. “The development of [AI] in France is a priority. It's a matter of gauging it,” Loïc Chabanier, an EY partner responsible for health care, told BioWorld.

LONDON – Oviva AG has raised US$21 million in a series B funding to further advance commercialization of its digital diabetes treatment program across Europe.

LONDON – The European Commission has published new guidelines on cybersecurity for medical devices, putting flesh on the bones of the requirements in the Medical Device Regulation (MDR) that comes into force in May.

LONDON – Cognetivity Neurosciences Ltd. has received CE software as a medical device approval for its cognitive assessment tool, a five-minute test intended as a diagnostic aid to identifying the earliest stages of dementia.

PARIS – The Cour des comptes, supreme body for auditing the use of public funds in France, independent from government and parliament, has just released its report on the operation of the French National Agency for the Safety of Medicines and Health Products (ANSM). Following 10 months of administrative and financial investigation, these financial controllers have highlighted the weakness of controls applied to medical devices placed on the market in France.

Dublin-based Medtronic plc received a CE mark for its Percept PC neurostimulator to treat neurologic disorders such as Parkinson’s disease. It is the first deep brain stimulation system launched in the EU that integrates the company’s technology to sense and record brain signals, known as Brainsense. It’s intended to enable more personalized treatment driven by that data.

Issy-les-Moulineaux, France-based Withings SA said it’s planning to launch its latest product in the U.S. and Europe during the second quarter, the Scanwatch. It is expected to be the first smartwatch to offer both atrial fibrillation (AF) and sleep apnea detection; a CE mark and FDA clearance are both pending. Cardiac arrhythmia and sleep apnea are associated with one another and can be precursors to more serious health problems such as heart attack or stroke.