Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Calibre Scientific, Mermaid Medical, Prometheus Medical, Response Plus, Ruwag Handels, Safeguard Medical, Single Pass.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomimetic, Curiteva, Evoluction Device, Pi-Cardia, Thirona.
In a boon to older women worldwide, Bone Health Technologies Inc. received U.S. FDA clearance for its Osteoboost device, which reduces loss of bone strength in postmenopausal women. It is the first device cleared for intervention to slow loss of bone density or osteopenia before it advances to osteoporosis.
Clarius Mobile Health Inc. received CE mark for its latest wireless hand-held whole-body ultrasound scanner, the Clarius PAL HD3. The scanner combines both phased and linear arrays on a single head which provides high image quality of superficial and deep anatomy allowing for better diagnostic capabilities and patient care.
The question of the U.S. FDA’s statutory authority to regulate lab-developed tests (LDTs) is still percolating, and the FDA and the Centers for Medicare & Medicaid Services (CMS) have issued a joint statement that takes aim at that very question.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Modular Medical, Myriad Genetics, Quantum-Si, Tomy Digital.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biomimetic Innovations.
Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six months after infection. Translationally, it could lead to a diagnostic test for long COVID, and suggests that targeting the complement system could be a therapeutic approach to prevent or treat the disorder.
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101.
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