cardiac survival News
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Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s NEURESCUE® device for temporary occlusion of large vessels, including patients requiring emergency ...
By Neurescue
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1 out of 10 survive cardiac arrest, a new device under FDA review hopes to change that
KEY POINTS Cardiac arrest is one of the leading causes of death in the U.S. and globally. It has a survival rate of 1 in 10 people with current treatment. The Neurescue device is designed to increase blood flow to the brain and heart during life-threatening emergencies such as cardiac arrest. Cardiac arrest is one of the leading causes of death around the world, ...
By Neurescue
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Celixir announces US FDA approval of the IND application for cell therapy Heartcell
FDA IND and UK MHRA CTA approval both achieved in H1 2018 Potentially pivotal heart failure trial of up to 250 patients in the UK and US Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for Heartcel, its immune-modulatory ...
By Celixir plc
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CTA approval for potentially pivotal Heartcel Phase IIb trial
Adult heart failure trial to complete in 2020 with potential market entry in 2021 Trial to be conducted at Imperial College London’s Royal Brompton, UK Celixir, a private company discovering and developing lifesaving regenerative medicines, today announced it has received formal clinical trial application (CTA) approval from the Medicines and Healthcare Products Regulatory Agency to ...
By Celixir plc
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BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada
BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to expand into Canada. The Phase III pivotal trial is currently enrolling ...
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BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure
BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed to be the first cardiac cell therapy to ...
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