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Software as a Medical Device (SaMD)
Digital therapeutics, clinical validation, and regulatory pathways for SaMD.
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Latest in Software as a Medical Device (SaMD)
Microbiome Labs Unveils Enhanced Online Ordering Experience and Rebrand Shaped by Practitioner and Customer Feedback
21+ hour, 44+ min ago (231+ words) Unveiled at the 2026 Microbiome Keynotes Symposium in Nashville, Tennessee, the milestones extend care beyond the office visit and create one connected place for practitioners and patients to shop, learn and stay engaged. Microbiome Labs - Makers of Megaspore Biotic Danny Deutsch,…...
Lord’s Mark Industries Advances UK & Allied Countries Expansion with MHRA Registration for IVD Portfolio | Hindustan Times
1+ day, 4+ hour ago (381+ words) Hindustan Times Within days of announcing its MHRA registration for its AI-powered Renalyx haemodialysis system, Lordâs Mark Industries Limited has secured another regulatory milestone in the UK & UK allied markets, with its IVD portfolio registered with the UKâs…...
Microbiome testing company Tiny Health clinches $33M to scale research, enterprise partnerships
5+ day, 13+ hour ago (545+ words) Tiny Health, a microbiome testing company, has clinched $33 million in an oversubscribed series B round. Capital B led the round, with participation from Spero Ventures, Black Opal Ventures, Pave Health Ventures, Alumni Ventures, Gaingels and others. The capital, which brings…...
Epsilon Health Raises $27.6 Million To Scale AI-Native Radiology Practice
3+ week, 5+ day ago (306+ words) Rather than developing an AI model focused on a single disease or imaging modality, Epsilon built the technology directly into a functioning radiology practice. Its purpose-built AI works alongside board-certified radiologists, accelerating clinical workflows while preserving existing care processes. The…...
MHRA and Manchester trust launch medical technology testing programme for the NHS
3+ week, 5+ day ago (342+ words) A trust and the Medicines and Healthcare products Regulatory Agency have established a programme to test emerging medical technologies in NHS settings, with AI-enabled devices among the first technologies expected to be assessed The Medicines and Healthcare products Regulatory Agency…...