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Blue Arbor Technologies Receives FDA Breakthrough Device Designation and TAP Enrollment for the RESTORE™ Neuromuscular Interface System

Blue Arbor Technologies Receives FDA Breakthrough Device Designation and TAP Enrollment for the RESTORE™ Neuromuscular Interface System
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Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and CompanyOnce approved, the test will aid healthcare providers in...

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Roche Granted FDA Breakthrough Device Designation For Blood Test To Support Earlier Alzheimer's Disease Diagnosis

Roche Granted FDA Breakthrough Device Designation For Blood Test To Support Earlier Alzheimer's Disease Diagnosis
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V-Wave Announces Late-Breaking Primary Results from Pivotal, Double-Blind, Randomized, Controlled RELIEVE-HF Trial of the Ventura® Interatrial Shunt Showing Reduced Clinical Events in Advanced Heart Failure Patients with Reduced Left Ventricular Ejection Fraction

V-Wave Announces Late-Breaking Primary Results from Pivotal, Double-Blind, Randomized, Controlled RELIEVE-HF Trial of the Ventura® Interatrial Shunt Showing Reduced Clinical Events in Advanced Heart Failure Patients with Reduced Left Ventricular Ejection Fraction
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V-Wave Announces Late-Breaking Primary Results from Pivotal, Double-Blind, Randomized, Controlled RELIEVE-HF Trial of the Ventura® Interatrial Shunt Showing Reduced Clinical Events in Advanced Heart Failure Patients with Reduced Left Ventricular Ejection Fraction

Results presented at ACC.24 showed that overall neutral results were due to directionally opposite effects in patients with reduced vs. preserved left ventricular ejection fraction

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V-Wave Announces Late-Breaking Primary Results from Pivotal, Double-Blind, Randomized, Controlled RELIEVE-HF Trial of the Ventura® Interatrial Shunt Showing Reduced Clinical Events in Advanced Heart Failure Patients with Reduced Left Ventricular Ejection Fraction

V-Wave Announces Late-Breaking Primary Results from Pivotal, Double-Blind, Randomized, Controlled RELIEVE-HF Trial of the Ventura® Interatrial Shunt Showing Reduced Clinical Events in Advanced Heart Failure Patients with Reduced Left Ventricular Ejection Fraction
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V-Wave to Present Late-Breaking Data from Pivotal RELIEVE-HF Study at American College of Cardiology Annual Scientific Session and Expo

V-Wave announced it will present late-breaking data from its RELIEVE-HF pivotal trial at ACC24

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Evoque and Patisiran: A Tale of Two Regulatory Journeys

Evoque and Patisiran: A Tale of Two Regulatory Journeys
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V-Wave to Present Late-Breaking Data from Pivotal RELIEVE-HF Study at American College of Cardiology Annual Scientific Session & Expo

/PRNewswire/ -- V-Wave today announced it will present late-breaking data from its RELIEVE-HF pivotal trial at the American College of Cardiology's (ACC)...

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FDA Roundup: March 22, 2024

FDA Roundup: March 22, 2024
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