Diagnostics FDA Cleared

Drawbridge Health Receives FDA 510(k) Clearance for OneDraw™ A1C Test System

Released on August 22, 2019

MENLO PARK, Calif., Aug. 22, 2019 /PRNewswire/ — Drawbridge Health today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the…

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FDA Cleared Spine

Nexxt Spine wins clearance for Matrixx stand-alone cervical implant

Released on August 18, 2019

Nexxt Spine said last week that it won 510(k) clearance from the FDA for its Nexxt Matrixx stand-alone cervical system….

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FDA Cleared MedTech

DigniCap Delta Hair Loss Prevention System for Chemo Now in U.S.

Released on August 15, 2019

The system pumps a cool liquid, carefully controlled thanks to a number of sensors, through a cap worn by patients undergoing chemo…

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FDA Cleared Imaging

NvisionVLE System FDA Cleared to Analyze Pancreas and Bile Duct

Released on August 13, 2019

NinePoint Medical, based out of Bedford, Massachusetts, won FDA clearance for its NvisionVLE Imaging System to be used in…

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FDA Cleared Imaging

NinePoint Medical wins FDA clearance for NvisionVLE

Released on August 8, 2019

The NvisionVLE Imaging System gives physicians real-time, high-resolution volumetric images of…

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Digital Health FDA Cleared

Voluntis gets FDA nod for its Oleena cancer management product

Released on August 7, 2019

Oleena has been developed to work across a range of cancer types and anti-cancer treatments including…

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Diagnostics FDA Cleared

PrisMax for Continuous Renal Replacement Therapy FDA Cleared

Released on August 2, 2019

Baxter won FDA clearance for its PrisMax system and accompanying TherMax blood warmer…

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FDA Cleared Vascular

Centerline’s Radiation-Free IOPS System for Minimally Invasive Procedures

Released on July 16, 2019

Centerline Biomedical, a company based in Cleveland, Ohio, landed FDA clearance for its Intra-Operative Positioning System (IOPS). The product provides physicians […]

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Cardiology FDA Cleared

VIVO 3-D Cardiac Mapping System Cleared by FDA

Released on July 1, 2019

Catheter Precision Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its new…

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Cardiology FDA Cleared

BraveHeart Wireless Announces FDA Clearance of the BraveHeart Life Sensor Cardiac Monitoring System

Released on July 1, 2019

The system captures heart rate and EKG data using a Life Sensor electrode affixed to a patient’s skin…

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FDA Cleared Robotics Surgery

Look Out Mako, Here Comes Rosa

Released on June 19, 2019

FDA cleared the system for use in robotically-assisted total knee replacement procedures in January…

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Cardiology FDA Cleared

CorMatrix Cor PATCH for Repair of Broken Hearts Gets FDA Clearance

Released on June 14, 2019

he device is indicated for use at the locations of aneurysms, in adults who have suffered a heart attack that led…

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