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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...
Healthcare

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...
Healthcare

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)...
Healthcare

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...
Healthcare

Latest EnsoData FDA 510(k) Clearance Enables AI-Powered Sleep Diagnosis Using Pulse Oximetry Devices

EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox)...
Healthcare

Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver

Nanox’s HealthFLD is pioneering the use of a fully automated AI software for liver attenuation analysis from CT scans that has received FDA 510(k) clearance for...
Healthcare

BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)

Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for treatment of patients with metastatic SCNC with progression on chemotherapy and no evidence...
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