CARMAT Announces the First Human Implant of its Total Artificial Heart in the United States

By rw-admin | July 18, 2021 | Comments Off on CARMAT Announces the First Human Implant of its Total Artificial Heart in the United States

CARMAT, the designer and developer of the total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the first implantation of its bioprosthetic artificial heart, Aeson, in the United States within the framework of the Early Feasibility Study (EFS). The implant…

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Dexcom Wins FDA Nod for Real-time APIs, Allowing Third-party Developers Access to CGM Data

By rw-admin | July 18, 2021 | Comments Off on Dexcom Wins FDA Nod for Real-time APIs, Allowing Third-party Developers Access to CGM Data

Dexcom’s Partner Web Application Programming Interfaces (APIs) were cleared by the FDA, allowing approved third-party developers to connect to the continuous glucose monitoring data of Dexcom users. Developers can integrate CGM data with their applications, diabetes management systems or devices through the new APIs, according to Thursday’s announcement. Diabetes management companies like Teladoc Health’s Livongo for Diabetes and…

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Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius High Frequency Nerve Block System

By rw-admin | July 5, 2021 | Comments Off on Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius High Frequency Nerve Block System

Neuros Medical, Inc., announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable pain of the lower limb of adult amputees. The FDA Breakthrough Device Program is intended to help patients…

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Interventional Systems Receives FDA Clearance for Miniature Surgical Robot for Needle-based Procedures

By rw-admin | July 5, 2021 | Comments Off on Interventional Systems Receives FDA Clearance for Miniature Surgical Robot for Needle-based Procedures

Interventional Systems announced Micromate, the world’s smallest robot for percutaneous procedures, received its FDA 510(k) clearance, allowing the robotics company to operate in the USA. Micromate is a table-mounted medical robot for interventional procedures with a universal instrument guidance solution that allows physicians to continue using their preferred surgical instruments. Targeting is performed under live-imaging using…

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