Bridge to Life(TM) Secures FDA De Novo Clearance for VitaSmart(TM) Hypothermic Oxygenated Perfusion (HOPE) System, the First Ever U.S. Approval for Cold Machine Perfusion in ...

The FDA clearance enables the commercial use of VitaSmart (TM) for hypothermic oxygenated perfusion of donor livers following static cold storage and prior to transplantation, providing a clear, ...
MedTech Dive

J&J submits FDA de novo request for Ottava robot in general surgery

Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft ...
Charlotte Observer

Augnition Labs Announces FDA Classification for Flagship Product, AugMem(TM)

NEW YORK CITY, NEW YORK / ACCESS Newswire / June 12, 2025 / Augnition Labs, a neurotechnology company developing science-driven tools to advance cognitive health, today announced that its flagship ...
MobiHealthNews

SPR Therapeutics gains FDA clearance for update to its percutaneous, wearable pain relief platform

Editor's note: This article has been updated to clarify FDA classification of the Sprint Peripheral Nerve Stinulation system. Cleveland, Ohio-based SPR Therapeutics announced today that it has ...
Business Wire

MMI Receives FDA Authorization to Commercialize Symani® Surgical System in the U.S.

JACKSONVILLE, Fla.--(BUSINESS WIRE)--MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex ...

Bridge to Life™ Secures FDA De Novo Clearance for VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System, the First Ever U.S. Approval for Cold Machine Perfusion in ...

Bridge to Life™ Ltd., a global innovator in organ preservation and perfusion technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the ...

Bridge To Lifetm Secures FDA De Novo Clearance For Vitasmarttm Hypothermic Oxygenated Perfusion (HOPE) System, The First Device Cleared In The U.S. For Hypothermic Oxygenated ...

Bridge To Lifetm Secures FDA De Novo Clearance For Vitasmarttm Hypothermic Oxygenated Perfusion (HOPE) System, The First Device Cleared In The U.S. For Hypothermic Oxygenated Perfusion Of Donor Livers ...
Pharmabiz

Bridge to Life gets US FDA De Novo clearance for VitaSmart HOPE System, the first device cleared in the US for hypothermic oxygenated perfusion of donor livers

Bridge to Life gets US FDA De Novo clearance for VitaSmart HOPE System, the first device cleared in the US for hypothermic oxygenated perfusion of donor livers: Duluth, Georgia We ...

Bridge to Life™ Secures FDA De Novo Clearance for VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System, the First Device Cleared in the U.S. for Hypothermic Oxygenated ...

Bridge to Life™ Ltd., a global innovator in organ preservation and perfusion technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the ...

Bridge to Life, Ltd.: Bridge to Life Secures FDA De Novo Clearance for VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System, the First Device Cleared in the U.S. for ...

FDA-cleared labeling supports broad clinical applicability, including Donation after Circulatory Death (DCD) donors, and positions VitaSmart as a scalable and economically compelling platform ...