Search Results for 'breakthrough'
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FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test
Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.Globe Newswire 03.30.20
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Neurological
Neuronetics' TMS Device for Bipolar Depression Wins Breakthrough Status
Could potentially provide more effective treatment with limited safety concerns.GlobeNewswire 03.06.20
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Cardiovascular
Aria CV's Pulmonary Hypertension System Wins Breakthrough Status
System is designed to restore the benefits of a healthy, elastic pulmonary artery.Business Wire 02.06.20
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Cardiovascular | Digital Health
ECG-Based Algorithm for Detecting Heart Failure Wins Breakthrough Status
Developed in collaboration with Mayo Clinic, Eko's algorithm would help detect an ailing heart during a standard physical exam.Globe Newswire 02.04.20
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Patient Monitoring
ArcherDX's Personalized Cancer Monitoring Wins Breakthrough Status
First surveillance tests designed to enable community hospitals and labs to deliver rapid, accurate, and actionable genomic information.PR Newswire 01.15.20
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Cytotron Gains Breakthrough Status to Treat Breast, Liver, and Pancreatic Cancers
The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues.PR Newswire 10.31.19
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Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program
Sean Fenske and Mike Drues discuss a relatively new program from the FDA—the Breakthrough Devices Program—and what it offers to medtech manufacturers.Sean Fenske, Editor-in-Chief 08.06.19
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Cardiovascular | Surgical
B. Braun's SeQuent Please ReX Drug-Coated PTCA Balloon Catheter Wins Breakthrough Status
SeQuent Please ReX is the latest generation coronary drug-coated balloon (DCB) catheter developed by B. Braun.GlobeNewswire 08.02.19
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Diagnostics | Neurological
FDA Awards Breakthrough Status to Blood Test to Determine Alzheimer's Risk
Breakthrough Device Designation granted to C2N’s proprietary blood test for the initial screening of amyloid pathology in the brain associated with Alzheimer's.Business Wire 01.29.19
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Diagnostics
FDA Grants Breakthrough Device Designation to Siemens Healthineers’ ELF Test
The company is collaborating with Gilead Sciences as part of its work to seek clearance of the test.Siemens Healthineers 11.09.18
