The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.

PARIS – Oncomfort SA has entered a partnership with Vygon SA for distribution of its Sedakit in six countries in Europe. The synergy between Vygon’s specialization and Oncomfort’s fields of application aims to enable greater acceleration of the adoption of Digital Sedation by health care professionals and patients. “Thanks to this strategic partnership, our new technology for relieving patient pain and anxiety without medication is going to be widely available in Europe,” Mario Huyghe, CEO of Oncomfort, told BioWorld.

LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation.

By analyzing patients’ reactions to treatment, Oncohost Ltd.’s proteomics-based platform enables earlier prediction of paradoxical responses to immunotherapy that promote tumor growth in certain cancers. The artificial intelligence-powered host response profiling platform, called Prophet, could help identify the best combination of therapies and minimize adverse effects from treatments that are unlikely to be beneficial.