Regulation — older stories
82 stories beyond the latest 40.
- 121RegulationSource · Medical Design & Outsourcing
Regulatory tips from a breakthrough noninvasive device startup
Compremium's Quantis CVP, a noninvasive central venous pressure measurement device, received FDA Breakthrough Device designation in January 2026 and was enrolled in the FDA's Total Product Life Cycle Advisory Program (TAP). The program provides regulatory guidance to accelerate development of high-priority medical devices. The designation and TAP enrollment support expedited patient access pathways for the device.
- 122RegulationSource · Fierce Healthcare
FDA clears first AI tool for breast cancer risk prediction from startup Clairity
The FDA cleared Clairity's AI tool for predicting five-year breast cancer risk from routine mammograms, marking the first FDA-cleared application of this kind. The software analyzes screening mammograms to generate individualized risk assessments, enabling radiologists and clinicians to tailor follow-up protocols and patient management strategies based on quantified risk levels.