The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE reviews Dexcom’s G6; Ortho claims EUA for antigen test with 100% sensitivity.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Brighter.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuhealth, Applied DNA Sciences, Bendit Technologies, Biocartis Group, Bone Therapeutics, Catalent Pharma Solutions, Closedloop.ai, DNAfit Life Sciences, Exact Sciences, Fitbit, Genomic Health, Health Catalyst, Livongo Health, Mammoth Biosciences, Mayo Clinic, Myapps, Natera, Optomec, Oxsed, Prenetics, Ping An, Premier Medical Laboratory Services, Progressive Care, Sanara Medical, Teladoc, Telli Health, Vocalis, Zerigo.
Tencent Holdings Ltd. has launched two med-tech solutions to facilitate data sharing and management with artificial intelligence capabilities, marking an additional step into the smart health care realm for the company. The Chinese tech giant unveiled the two products at the 83rd China International Medical Device Expo Oct. 20.
The pace at which companies are integrating the sophisticated tools of artificial intelligence (AI) and machine learning (ML) into their early stage drug discovery and development programs is accelerating, as evidenced by the creation of new dedicated AI-focused biopharma companies and the eagerness of drug developers to partner with AI firms.
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