Tag: FDA approval

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FDA OKs MiniMed 780G for Type 2 Diabetes and Approves Integration With Abbott Sensor

The automated insulin delivery system is now approved for adults with type 2 diabetes and cleared for interoperability with Abbott’s Instinct sensor for type 1 diabetes.

FDA Clears Esaote’s MyLab A50 and A70 Ultrasound Systems
FDA Updates Guidance on Third-Party 510(k) Review Program
FDA Clears CMR Surgical to Market Versius Surgical System
Philips Introduces 160 cm LumiGuide Endovascular Navigation Wire
FDA Tightens Medical Device Cybersecurity Regulations
FDA Proposes Ban on Electrical Stimulation Devices

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FDA OKs Vaporized Hydrogen Peroxide for Medical Device Sterilization

The FDA announced that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices.

FDA Creates UV Microbial Reduction Device Category
FDA Approves Canady Flex RoboWrist Robotic Surgery Device

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FDA OKs MiniMed 780G for Type 2 Diabetes and Approves Integration With Abbott Sensor

The automated insulin delivery system is now approved for adults with type 2 diabetes and cleared for interoperability with Abbott’s Instinct sensor for type 1 diabetes.

FDA Clears Esaote’s MyLab A50 and A70 Ultrasound Systems
FDA Updates Guidance on Third-Party 510(k) Review Program
FDA Clears CMR Surgical to Market Versius Surgical System
Philips Introduces 160 cm LumiGuide Endovascular Navigation Wire
FDA Tightens Medical Device Cybersecurity Regulations
FDA Proposes Ban on Electrical Stimulation Devices

Tag: FDA approval

All

FDA OKs MiniMed 780G for Type 2 Diabetes and Approves Integration With Abbott Sensor

FDA Clears Esaote’s MyLab A50 and A70 Ultrasound Systems

FDA Updates Guidance on Third-Party 510(k) Review Program

FDA Clears CMR Surgical to Market Versius Surgical System

Philips Introduces 160 cm LumiGuide Endovascular Navigation Wire

FDA Tightens Medical Device Cybersecurity Regulations

FDA Proposes Ban on Electrical Stimulation Devices

All

FDA OKs Vaporized Hydrogen Peroxide for Medical Device Sterilization

FDA Creates UV Microbial Reduction Device Category

FDA Approves Canady Flex RoboWrist Robotic Surgery Device

All

Sorry, No Posts Found

All

FDA OKs MiniMed 780G for Type 2 Diabetes and Approves Integration With Abbott Sensor

FDA Clears Esaote’s MyLab A50 and A70 Ultrasound Systems

FDA Updates Guidance on Third-Party 510(k) Review Program

FDA Clears CMR Surgical to Market Versius Surgical System

Philips Introduces 160 cm LumiGuide Endovascular Navigation Wire

FDA Tightens Medical Device Cybersecurity Regulations

FDA Proposes Ban on Electrical Stimulation Devices

Sorry, No Posts Found

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Sorry, No Posts Found

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