Seluna Ltd. launched a clinical study to validate its sleep diagnostic software, designed to support doctors to rapidly diagnose childhood sleep disorders and prioritize treatment for those who urgently need it. The study follows Seluna’s recent securing of nearly £650,000 (US$875,000) in funding.

On the heels of U.S. FDA approval for Neurophet Aqua, an updated version of its artificial intelligence (AI)-based magnetic resonance imaging analysis software for the brain, Neurophet Inc. is preparing for an IPO in 2025 and expansion into U.S. and European markets.

The U.S. Medicare program has a notorious problem with regard to coverage of digital products and software as a service, but the agency is dependent on Congress to add new benefit categories via legislation.

The clearance by the U.S. FDA of Healthccsng V2.0, an artificial intelligence cardiac solution developed by Nano-x Imaging Ltd.’s (Nanox) subsidiary, Nanox.AI, is highly “significant” for the company and will offer “substantial” benefits to cardiology departments by significantly enhancing the detection of coronary artery calcification, Erez Meltzer, Nanox CEO told BioWorld.

Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.

The first patenting from South Korea’s Neudive Inc. sees its CEO, SungJa Cho, applying for protection of the company’s mobile digital social therapy device, NDTx-01, which helps build the social skills of neurodiverse individuals, and in particular children and adolescents with autism spectrum disorder and social communication disorder.

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.

After a rocky year, Akili Inc. received U.S. FDA clearance for use of its non-prescription product, Endeavorotc, for treatment of adults with attention deficit/hyperactivity disorder (ADHD). Endeavorotc employs a video game format to improve attention in individuals with inattentive or combined-type ADHD.

The U.S. Federal Trade Commission (FTC) finalized its overhaul of the health breach notification rule (HBNR), significantly expanding the types of software products subject to the agency’s oversight. However, the final rule was approved by the commission by a narrow 3-2 vote and was the subject of a scathing critique by the two dissenting commissioners, who argued that the FTC has once again exceeded its statutory authority in rewriting the HBNR.

Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB.