FDA Approved

Eversense Implantable Glucometer Gets FDA Approval as Alternative to Finger Tests

Released on June 10, 2019

This is a giant step for the company, which has developed a technology that combines …

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Cardiology FDA Approved

GORE CARDIOFORM Approved by FDA to Treat Atrial Septal Defects

Released on June 7, 2019

The GORE CARDIOFORM Septal Occluder has been approved by the FDA to treat…

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CE Mark FDA Approved Robotics

ReWalk Exo-Suit Gets Green Light in U.S., Europe to Aid Stroke Recovery

Released on June 5, 2019

ReWalk Robotics, a company with offices in Marlborough, Massachusetts and Yokneam Ilit, Israel, won…

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FDA Approved MedTech

Novocure nets approval for its Tumor Treating Fields therapy in mesothelioma

Released on May 31, 2019

The NovoTTF-100L system was classified by the FDA as a humanitarian use device and was approved under a…

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FDA Approved

Gore Scores FDA Nod for More Precise TEVAR Solution

Released on May 21, 2019

W.L. Gore and Associates has received a nod from FDA for a more precise Thoracic Endovascular Aortic Repair (TEVAR) solution…

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Cardiology FDA Approved

Masimo Radius PPG Wireless Oximeter FDA Cleared

Released on May 21, 2019

Masimo won FDA clearance for its Radius PPG wireless pulse oximetry sensor…

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Cardiology FDA Approved

Impella CP with SmartAssist: A Newly FDA Approved Heart Pump with Optical Positioning Sensor

Released on May 20, 2019

Abiomed, the maker of popular left ventricular assist devices, is releasing its newly FDA approved Impella CP with SmartAssist device…

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Cardiology FDA Approved

AliveCor wins FDA nod for 6-lead personal ECG

Released on May 17, 2019

AliveCor said today that it won FDA clearance for its KardiaMobile 6L six-lead personal ECG device, touting it as the first device of its kind to win FDA clearance…

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FDA Approved

Aidoc gets FDA nod for AI pulmonary embolism screening tool

Released on May 15, 2019

Aidoc’s technology doesn’t require dedicated hardware and runs continuously on hospital systems, automatically ingesting radiological images…

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FDA Approved Radiology

Zebra Medical Vision lands FDA approval for AI pneumothorax alert product

Released on May 14, 2019

Zebra Medical Vision, an Israeli medical imaging analytics company, has received FDA 510(k) clearance for…

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FDA Approved Vascular

Boston Scientific Launches New Stent for Venous Obstructive Disease

Released on May 6, 2019

Boston Scientific has won FDA approval for its Vici Venous Stent System for the treatment of…

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Cardiology Digital Health FDA Approved

VivaQuant RX-1 Wearable All-in-One Mobile Cardiac Telemetry Unit and Event Monitor FDA Cleared

Released on May 3, 2019

The device is unique in that it is able to operate as a Mobile Cardiac Telemetry unit or Event Monitor…

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