DUBLIN – “Welcome to the conversation,” Abbvie Inc.’s head of genomic research, Howard Jacob, an early pioneer of genomics-driven medicine, told delegates during a keynote address at the Genomics Summit 2020 event Jan. 23. Ireland is very much a latecomer to that conversation and it has yet, as a country, to figure out what the shape of its contribution to the genomic era of medicine is going to be.
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 – The European Commission has published new guidelines on cybersecurity for medical devices, putting flesh on the bones of the requirements in the Medical Devices 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.
LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.
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.