Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.

The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products.

Cureosity GmbH has raised €3.8 million (US$4.1 million) in growth financing to expand the use of its virtual reality therapy which promotes the sensorimotor and cognitive rehabilitation in patients who have suffered a stroke or with neurodegenerative diseases. The funding came from existing and new investors including Techvision Fonds and Nomainvest, a Belgian family office.

A team of researchers have developed a blood test which uses artificial intelligence to predict Parkinson’s disease in patients up to seven years before symptoms appear. The test, based on the identification of eight biomarkers in the blood, will be able to identify patients who can be treated earlier with therapies to slow down the progression of the disease or even prevent it from occurring.

Scientists spread across Europe and the U.S. filed for protection of an implantable electrode array including a plurality of microneedles, which may be implanted into the auditory nerve bundle and stimulate the auditory nerve in response to receiving electrical signals representative of observed sounds.

Dexcom Inc. and Insulet Corp. both reported introductions of their products into new countries on the eve of the 2024 American Diabetes Association annual meeting in Orlando, Fla. The two firms also announced the U.S. launch of Insulet’s Omnipod 5 tubeless automated insulin delivery system with connectivity to Dexcom’s G7, the company’s latest generation continuous glucose monitor.

As new treatment options are being continually investigated and trialed against Parkinson’s disease, the possibilities offered by deep brain stimulation (DBS) risk being overlooked. Though not a cure, the therapy could vastly improve the quality of life for patients with the disease.

Advanced Oxygen Therapy Inc. raised £35.1 million (US$44.5 million) in its initial public offering on London’s AIM market. The move by the U.S.-based company is a bid to broaden adoption of its chronic wound care technologies.

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.