Verana Health Expands MIPS Advisory to Boost Clinical Compliance
SAN FRANCISCO, Calif., Oct. 7, 2025 — Verana Health announced the expansion of its MIPS Advisory Services, offering enhanced...
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AorticLab Secures FDA IDE Approval for FLOWer™ Clinical Pivotal Trial
TORINO, Italy – October 2, 2025 – AorticLab has achieved a major milestone with the U.S. Food and Drug...
Meridian Bioscience Launches First Liquid Ambient qPCR Master Mixes
CINCINNATI, OHIO, September 16, 2025 – Meridian Bioscience, Inc., a global leader in diagnostics and life science raw materials,...
AliveDx Submits FDA 510(k) for MosaiQ AiPlex® Vasculitis Assay to Advance Autoimmune Diagnostics
AliveDx, a global in-vitro diagnostics innovator, today announced it has submitted a 510(k) premarket notification to the U.S. Food...
GeneseeqPrime Gains FDA 510(k) Clearance for Tumor Profiling Kit
TORONTO, Sept. 2, 2025 – Geneseeq Technology Inc. announced that its GeneseeqPrime® NGS Tumor Profiling Assay has received 510(k)...
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Phraxis Marks First Commercial Use of EndoForce Anastomotic Connector
MINNEAPOLIS, August 29, 2025 — Phraxis announced the successful completion of the first-ever commercial case using its EndoForce Anastomotic...
Bio-Thera and STADA Expand Alliance with Biosimilars-Tocilizumab
August 22, 2025 — Bio-Thera Solutions and STADA Arzneimittel have announced the expansion of their biosimilars partnership to include...
FDA Recalls Frozen Shrimp Because of Possible Health Risk
August 21, 2025: The U.S. Food and Drug Administration (FDA) has issued a public health advisory cautioning against consumption,...
SmartAlpha’s Ultrasound AI Software Nerveblox Gains FDA 510(k) Approval
ANKARA, Türkiye, August 18, 2025 — SmartAlpha’s AI-powered software, Nerveblox, designed to assist clinicians performing ultrasound-guided regional anesthesia (“nerve...
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