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    Regulatory Approvals

    FDA approves CT LUCIA 621P Monofocal IOL from Zeiss

    Zeiss announced the US Food and Drug Administration (FDA) approval of CT LUCIA 621P Monofocal IOL.1 This aspheric, monofocal, single-piece C-loop IOL features optic (ZO)...

    Insulet Announces FDA Clearance of Omnipod GO™, a First-of-its-Kind Basal-Only Insulin Pod, Further Simplifying Life for People with Type 2 Diabetes

    Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, announced the FDA clearance of...

    FDA Approves Medtronic MiniMed™ 780G System – World’s First Insulin Pump with Meal Detection Technology* Featuring 5-Minute Auto Corrections†§

     Medtronic plc (NYSE: MDT), the global leader in medical technology, announced U.S. Food and Drug Administration (FDA) approval of its MiniMed™ 780G system with the Guardian™...

    GE HealthCare receives FDA approval for CARESCAPE Canvas platform

    GE HealthCare (Nasdaq: GEHC) today announced US FDA 510(k) clearance of its CARESCAPE Canvas patient monitoring platform for precise, flexible patient care. CARESCAPE Canvas and CARESCAPE ONE are...

    FDA Approval for BIOTRONIK’s Prospera™ Spinal Cord Stimulation System

    Global Leader in Cardiac Rhythm Technology Solutions Expands Therapies for the Treatment of Chronic Intractable Pain with a New Approach to Managing Spinal Cord...

    Masimo Announces FDA Clearance of the Rad-G® with Temperature

    Masimo (NASDAQ: MASI) announced that the Rad-G® with Temperature has received FDA 510(k) clearance. Rad-G with Temperature is a rugged, versatile, handheld monitor that provides clinically...

    Moon Surgical Secures CE Mark for Maestro™ Surgical Robotic System

    Moon Surgical has announced that its Maestro System is now CE Marked under the Medical Device Regulation (EU) 2017/745. “This new milestone is a testament to...

    Avation Medical Announces US FDA 510(k) Clearance for The Vivally® System, a wearable bladder control therapy and mobile app to treat patients with urinary...

    Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, announced that its Vivally System received US Food...

    FDA approves Icentia’s ECG monitoring solution CardioSTAT

    Medical practitioners can use the device to detect difficult-to-identify heart anomalies such as atrial fibrillation. Canadian medical technology company Icentia has secured 510(k) clearance from...
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