FDA Clearance – Medical Alley Association

FDA Clearance

Healthy.io Raises $60 Million in Series C Funding and Receives FDA Clearance for Smartphone-Based Test to Diagnose Chronic Kidney Disease

Former Aetna executive Gary Loveman will join Board of Directors Tel Aviv, Israel (September 12, 2019) ⁠— Today, Healthy.io, the global leader in turning the smartphone camera into a clinical-grade medical device, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney […]

PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers

FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms Clearance allows physIQ to power its higher-level AI analytics with validated vital sign inputs PhysIQ’s cloud-based analytics provide flexibility to biopharma companies and payers looking for consistent output while deploying a variety of devices across different patient populations CHICAGO – PhysIQ, […]

Magstim TMS Receives FDA Clearance For 3-Minute Theta Burst Treatment

Magstim has received FDA clearance to include intermittent Theta Burst Stimulation (iTBS) as a treatment for Major Depressive Disorder with its Horizon ® TMS Therapy systems. The Horizon ® system was designed to offer more versatility in one system, and more treatment options for patients.  This clearance allows Magstim to market the 3-minute iTBS protocol.  […]

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