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Q’Apel Medical Announces CE Mark Approval for Armadillo SelectFlex™ Neurovascular Access System

January 13, 2025

FREMONT, Calif., Jan. 13, 2025 /PRNewswire/ — Q’Apel Medical (Q’Apel), a privately held medical device company focused on revolutionizing neurovascular interventions, today announced it has received CE mark certification for its Armadillo SelectFlex™ Neurovascular Access System. The first-of-its-kind 7F system features the patented SelectFlex™ Technology and is indicated for the introduction of interventional devices into the neurovasculature.

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ZEISS MEL 90 excimer laser receives U.S. FDA approval; completes Corneal Refractive Workflow

January 13, 2025

DUBLIN, Calif. and JENA, Germany, Jan. 13, 2025 /PRNewswire/ — ZEISS Medical Technology announced today that the MEL® 90 received approval from the U.S. Food and Drug Administration (FDA), giving the excimer laser technology simultaneous approval for all three major indications, including myopia, hyperopia and mixed astigmatism (a condition where both hyperopic and myopic correction is required).

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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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