Tag: breakthrough device

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Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

FDA TAP Pilot Adds Neurological and Physical Medicine Devices
Innoblative SIRA RFA Gets FDA Breakthrough Device Designation
RenalGuard Therapy Gets Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI
Opticyte’s Patient Monitor for Organ Failure Earns Breakthrough Device Designation
CorVista Gets Breakthrough Device Designation for Pulmonary Hypertension Diagnostic Solution
Non-Invasive Monitor Tech for Sepsis Gets FDA Breakthrough Device Designation

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Philips Laser Assisted IVC Filter Removal Gets FDA De Novo Clearance

The FDA granted De Novo Clearance for the Philips Inferior Vena Cava Filter Removal Laser Sheath to remove an IVC filter when other methods have failed.

Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation
Stimdia pdSTIM System Receives FDA Breakthrough Device Designation
MITA Applauds CMS Medicare Coverage Pathway for Innovative Medical Technologies
CMS Proposes Rule to Expedite Medicare Approval of Breakthrough Devices
Aethlon Medical Earns NCI Grant to Research Breakthrough Device for Blood Purification

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Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

FDA TAP Pilot Adds Neurological and Physical Medicine Devices
Innoblative SIRA RFA Gets FDA Breakthrough Device Designation
RenalGuard Therapy Gets Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI
Opticyte’s Patient Monitor for Organ Failure Earns Breakthrough Device Designation
CorVista Gets Breakthrough Device Designation for Pulmonary Hypertension Diagnostic Solution
Non-Invasive Monitor Tech for Sepsis Gets FDA Breakthrough Device Designation