Medical Devices (Class II and Class III)

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IceCure Medical’s ProSense System Does Not Receive Clearance for Breast Cancer

September 20th 2023

The decision will not impact the device’s FDA clearance for other indications.

FDA Grants IDE Approval to Study of CereVasc’s eShunt System
FDA Grants IDE Approval to Study of CereVasc’s eShunt System

September 19th 2023

Limaca Medical's Precision GI Endoscopic Biopsy Device
Precision GI Endoscopic Biopsy Device Receives 510(k) Clearance From FDA

September 12th 2023

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OnPoint Surgical Announces 510(k) Clearance from FDA For Augmented Reality Spine System

September 11th 2023

FDA Grants Breakthrough Designation to Admetsys’ Automated Glucose and Continuous Blood Diagnostics System
FDA Grants Breakthrough Designation to Admetsys’ Automated Glucose and Continuous Blood Diagnostics System

September 7th 2023

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