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The Regulation Of New Medical Tech Is Becoming A Lifelong Process

Magenta Medical, developer of the world’s smallest heart pump, announced the completion of enrollment to its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular Assist Device for the high-risk percutaneous coronary intervention indication.

Magenta Medical, developer of the world’s smallest heart pump, announced a $55M financing round led by global healthcare investment manager OrbiMed, with participation from existing investors New Enterprise Associates, Pitango VC, and ALIVE - Israel HealthTech Fund.

As part of its Regenerative Neurology Program, Longevity Medical Institute® is making MUSE cell therapy available to select patients, using cells produced in-house at the Institute’s biotechnology laboratory.

The US Early Feasibility Study of Magenta Medical’s Elevate™ System, designed to provide temporary mechanical circulatory support during high-risk percutaneous coronary intervention (HR-PCI) procedures, has successfully met its objectives.

As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, suggests clinical considerations for medical device developers and anticipates AI-enabled SaMDs’ future progress.

Results from Magenta Medical’s Early Feasibility Study of the Elevate™ System, for the high-risk percutaneous coronary intervention (HR-PCI) indication, will be announced in an oral presentation at the Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco. Elevate™ is the world’s smallest and most powerful percutaneous Left Ventricular Assist Device (pLVAD).

Magenta Therapeutics, Inc. (Nasdaq: MGTA) (“Magenta”) and Dianthus Therapeutics, Inc. (“Dianthus”), a privately-held, clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, announced today that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction.

Magenta Therapeutics, Inc. announced that its Board of Directors has unanimously adopted a limited duration stockholder rights plan.

The US Early Feasibility Study of Magenta Medical’s Elevate™ System, designed to provide temporary mechanical circulatory support during high-risk percutaneous coronary intervention (HR-PCI) procedures, has successfully met its objectives. Elevate™ is the smallest and most powerful percutaneous Left Ventricular Assist Device (pLVAD) in the world.