Tag: breakthrough device

All

AI Multi-Triage Solution Earns FDA Breakthrough Designation

The designation will expedite the review process for the CT-based artificial intelligence, which flags numerous acute conditions simultaneously.

All

Innoblative SIRA RFA Gets FDA Breakthrough Device Designation

Innoblative's SIRA RFA Electrosurgical Device is intended for use in breast cancer patients undergoing BCS.

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
Philips Laser Assisted IVC Filter Removal Gets FDA De Novo Clearance
Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation

All

Stimdia pdSTIM System Receives FDA Breakthrough Device Designation

The Stimdia pdSTIM system is designed to facilitate weaning patients from mechanical ventilation by reconditioning the diaphragm.

All

AI Multi-Triage Solution Earns FDA Breakthrough Designation

The designation will expedite the review process for the CT-based artificial intelligence, which flags numerous acute conditions simultaneously.

Tag: breakthrough device

All

AI Multi-Triage Solution Earns FDA Breakthrough Designation

House Committee Advances Medicare Coverage Bill for Breakthrough Medical Devices

AdvaMed, Industry Groups Push for Faster Medicare Coverage of Breakthrough Devices

New Artificial Heart Technology Earns FDA Breakthrough Device Designation

FDA Grants Restore Medical ContraBand Breakthrough Designation

Admetsys Blood Diagnostic System Made Breakthrough Device

FDA TAP Pilot Adds Neurological and Physical Medicine Devices

All

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

Philips Laser Assisted IVC Filter Removal Gets FDA De Novo Clearance

Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation

All

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

All

AI Multi-Triage Solution Earns FDA Breakthrough Designation

House Committee Advances Medicare Coverage Bill for Breakthrough Medical Devices

AdvaMed, Industry Groups Push for Faster Medicare Coverage of Breakthrough Devices

New Artificial Heart Technology Earns FDA Breakthrough Device Designation

FDA Grants Restore Medical ContraBand Breakthrough Designation

Admetsys Blood Diagnostic System Made Breakthrough Device

FDA TAP Pilot Adds Neurological and Physical Medicine Devices

Sorry, No Posts Found

All

Sorry, No Posts Found

24×7

Our Parent Company

Key Resources

Helpful Links