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Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer’s disease diagnosis

Roche announced that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is...

Intelligencia AI Awarded U.S. Patent for Its Accurate and Transparent Probability of Drug Success Assessments

Intelligencia AI, a provider of AI-powered solutions that support data-driven decision-making in drug development, announced that the U.S. Patent and Trademark Office (USPTO) issued...

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive...

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn™ (developed as CT-152), the...

SyntheticMR receives FDA 510(k) clearance for their next Generation Solution SyMRI 3D

SyntheticMR announced that their next-generation imaging solution with isotropic resolution, SyMRI 3D, has received FDA 510(k) clearance for clinical use in the United States. SyntheticMR...

inHEART Receives FDA Clearance For Advanced AI-Driven Software Module That Optimizes The Creation Of 3D Models Of The Heart

Solution uses fully automated AI segmentation to generate inHEART's digital twin of the heart with greater speed and efficiency inHEART, a privately-held medical device company...

Intuitive Announces FDA Clearance of Fifth-Generation Robotic System, da Vinci 5

Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced that the U.S. Food and Drug Administration (FDA)...

GE HealthCare and Biofourmis Collaborate to Extend Patient Monitoring Outside the Hospital with Virtual Care-at-Home Solutions

Collaboration supports the patient journey across the care continuum and eases transitions and care from the hospital to home GE HealthCare and Biofourmis have announced a strategic...

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