Siemens Healthineers AG has received CE mark for a neurofilament light chain assay to help with the early diagnosis of multiple sclerosis and aid in predicting the risk of relapse in patients suffering from the disease. The test developed in collaboration with Novartis Pharma AG will be launched in Europe later this year.

For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.

Even patent attorneys aren’t particularly collectively excited about standard essential patents, but that hasn’t stopped the U.S. Patent and Trademark Office from signing a memorandum of understanding with the U.K. Intellectual Property Office to collaborate on policies related to these patents.

Aktiia SA recently received a CE mark for Calfree, its optical blood pressure monitoring technology that does not require calibration with a traditional cuff. The Calfree system can be integrated into a wide range of third-party devices, significantly improving hypertension management and as a result the quality of patients’ lives.

Amber Implants BV reported promising results from the first-in-human trial of patients fitted with its Vcfix spinal system which treats vertebral compression fractures. Data showed that patients experienced significant pain relief and regained the ability to walk without discomfort.

Amber Therapeutics Ltd. has raised $100 million in a series A funding round to further develop its implantable closed-loop bioelectrical therapy to treat women suffering from mixed urinary incontinence. The financing is one of the largest series A rounds ever seen in Europe’s medical technology space and comes at a time when many med-tech companies are struggling to raise funds.

In what represents its first patenting Demon Curonix BV is seeking protection for a system for providing microvesicles to be used in combination with focused ultrasound for drug delivery to the brain.

Isotope Technologies Munich SE (ITM) raised €188 million ($204 million) in a funding round that will largely be used to advance and expand the company’s radiopharmaceutical pipeline. The funds, which come a year after ITM raised €255 million, are a sign of growing investor interest in the company’s products and the radiopharma market, Steffen Schuster, CEO of ITM, told BioWorld.

Xeltis BV hopes that promising data from clinical trials on the performance of its synthetic vascular access graft implant will transform not only the lives of patients suffering from chronic kidney disease but also the company’s fortunes. “We're outperforming other solutions out there, that's the nice promise not only for the patient and for the families but also for potential strategics that might be interested in the company and play a role in the vascular space,” Eliane Schutte, CEO of Xeltis told BioWorld.

The €1.5 million ($US1.63 million) in pre-seed funding recently raised by En Carta Diagnostics SA is “key” for the company to be able to develop its point-of-care molecular diagnostics kits and generate clinical data, Guillaume Horreard, CEO at En Carta told BioWorld.