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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...
Automation in AI

Ezra, an Innovator in Applying AI to MRI Scanning, Raises $21M to Increase Access to Care

Healthier Capital, the venture capital firm led by former One Medical | Amazon CEO Amir Dan Rubin, co-leads round with FirstMark Capital, with participation...
Healthcare

Hologic Announces First and Only FDA-Cleared Digital Cytology System – Genius™ Digital Diagnostics System

Through a Combination of Advanced Imaging and Novel Artificial Intelligence, Latest Diagnostic System for Cervical Cancer Screening Can Help More Accurately Detect Disease, Improve...
Automation in AI

Copan Colibrí™ Receives Third FDA Clearance, Further Expanding Automated ID/AST Workup Capabilities

Copan Diagnostics, a leader in Clinical Microbiology automation solutions, has announced the third FDA clearance for its innovative pre-analytical processor, Colibrí™. The automated ID/AST...
Healthcare

Enhatch Announces FDA Clearance for a TKA Patient Specific Instrumentation System with AI-Assisted Segmentation and Treatment Planning

Enhatch Inc. is excited to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance of a patient specific instrumentation system for Total Knee...
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