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.

PARIS – Mauna Kea Technologies SA, of Paris, is welcoming a major shareholder on board. The company, which developed Cellvizio optical biopsy technology for tissue imaging directly at the cellular level, reported an increase in share capital for the benefit of Johnson & Johnson Innovation, JJDC Inc. The venture capital arm of J&J has invested $8.3 million by subscribing to 5,357,142 new shares at a unit price of $1.56.

LONDON – Twenty years on from sequencing of the first draft of the human genome and the associated hype, 2019 was the year that the science of genomics truly began to make an impact in health care.

LONDON – Following 3.5 years of uncertainty, the U.K. will be leaving the EU at 11 pm Jan. 31, after the newly elected Conservative government finally got the withdrawal agreement bill voted through Parliament Dec. 20, by a majority of 124.

PARIS – Diabnext SAS, of Versailles, France, has launched Clipsulin 3XS, a sensor intended to monitor and manage diabetes that the company says is compatible with all insulin pens on the market. “This is the first sensor that automatically reports insulin doses injected by the pen, in both children and adults,” Laurent Nicolas, co-founder and CEO of Diabnext, told BioWorld MedTech.

HONG KONG – Pentax Medical Co., of Tokyo, has gained CE marking for its artificial intelligence-based polyp detector Discovery. The detector assists endoscopists in finding potential polyps during a colorectal examination. The software has been trained using more than 120,000 files from about 300 clinical cases.

LONDON – While large-scale biobanks that link genomics to longitudinal health records of diagnosis, treatment and outcomes promise to revolutionize the understanding of the genetics of complex disease, the detailed statistical analysis of those high-dimensional data is still very much in its infancy.

PARIS – Biolog-id SAS, specialists in traceability and management of delicate health care products (red blood cells, plasma, platelets and chemotherapy substances), has just raised $33 million from fund managers Xerys Gestion. “Thanks to this new funding, we will be able to roll out our smart traceability solutions worldwide. These are used for managing labile blood products and plasma fractionation,” Jean-Claude Mongrenier, founder and CEO of the Boulogne-Billancourt, France-based company, told BioWorld MedTech.