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Spear Bio Secures FDA Breakthrough Device Designation for its Novel pTau 217 Blood Test, Advancing Scalable Solutions for Early Alzheimer’s Disease Diagnosis

January 13, 2025

WOBURN, Mass., Jan. 13, 2025 /PRNewswire/ — Spear Bio Inc., a biotechnology company pioneering next-generation ultra-sensitive immunoassays, today announced that its pTau 217 blood test has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognizes the test’s potential to address a critical unmet need for the millions of Americans living with Alzheimer’s disease and not yet diagnosed.

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Ventris Medical Receives 510(k) Clearance for Innovative Backpack® Bone Graft Containment System

January 9, 2025

NEWPORT BEACH, Calif., Jan. 9, 2025 /PRNewswire/ — Ventris Medical, a privately held orthobiologics and tissue regeneration company, today announced that the United States Food and Drug Administration has granted 510(k) clearance for Backpack® (Porous Biologic Scaffold, K240765)). Backpack® represents a new class of biomaterials designed for the optimization of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures. Backpack® is available in 2 versions. One version consists of a collagen mesh pouch prefilled with our osteoinductive Allocell® AF fibers and in the second version, the collagen mesh pouch is prefilled with our surface activated Amplify® granules.

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