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FDA Approves Expanded Indication for Max 3™ Syringeless MR Injector from Bracco

PRINCETON, N.J., Nov. 25, 2025 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication for the Bracco-branded Max 3™, a Rapid Exchange and Syringeless Injector for use in magnetic resonance imaging (MRI) procedures. In addition to single-dose and multi-dose vials, the Max 3™ system is now indicated for use with the newly approved VUEWAY® (gadopiclenol) injection Imaging Bulk Package (IBP) in 30 mL and 50 mL formats.

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Regenity Biosciences Marks 63rd FDA 510(k) Clearance with Expansion of Neurosurgical Portfolio

PARAMUS, N.J., Nov. 25, 2025 /PRNewswire/ — Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced its 63rd FDA 510(k) clearance for DuraMatrix® Repair – Collagen Dura Regeneration Membrane, a resorbable membrane composed of highly purified Type I and Type III bovine collagen for the repair of dura mater defects during neurosurgery.

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