FDA cleared Wellvii BP Go as a Class II non-invasive blood pressure system after published validation found its finger-based measurements met ISO 81060-2:2018 requirements.
Gossamer Bio’s structured financing provides $25 million initially, another $125 million if FDA accepts the seralutinib NDA in 2026 and potentially $100 million more following approval.
St. Joseph’s Health is integrating Coreline Soft’s AVIEW into its existing INFINITT PACS, allowing AI pre-analysis of lung screening CTs without sending radiologists into a separate application.
Vitruvias Therapeutics is recalling one nationwide lot of 30 mg Thyroid Tablets after testing found potential superpotency, highlighting the narrow dosing margins of thyroid hormone replacement.
MONARCH QUEST 3 adds AI nodule segmentation, improved registration, 3D orientation and broader cone-beam CT integration as Johnson & Johnson targets more reliable lung nodule navigation.
FibroBiologics expands its disc disease IP in Australia, but clinical validation and funding remain the bigger tests for its regenerative strategy.
China has cleared Akeso’s AK157D1 for Phase 1 testing in advanced solid tumors, adding a DXd-class B7-H3 programme to a target already attracting late-stage ADC competition.
FDA’s PMA supplement expands RHA Redensity Eye into infraorbital volume correction, backed by a 233-patient safety population and mandatory device-specific injector training.
The all-stock transaction values Ambros Therapeutics at $500 million and pairs its pivotal neridronate programme with a $150 million financing designed to fund development through Phase 3 data and an FDA filing.
Genentech will spend about $750 million to add end-to-end device fill-finish capabilities in Oregon, doubling its Hillsboro site and targeting commercial operations in 2031.