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Medtronic Receives FDA Breakthrough Designation for the Emprint Ablation Catheter Kit

Medtronic Receives FDA Breakthrough Designation for the Emprint Ablation Catheter Kit
Minimally Invasive Option Has Potential to Provide Long-Term Management of Lung Malignancies While Protecting Lung Function Medtronic plc the global leader in medical technology, today announced it has received Breakthrough Device Designation status from the U.S. Food and Drug Administration for the Emprint™ ablation catheter kit an investigational device not yet approved or cleared in the United States . The …
Minimally Invasive Option Has Potential to Provide Long-Term Management of Lung Malignancies While Protecting Lung Function
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the Emprint™ ablation catheter kit an investigational device not yet approved or cleared in the United States . The catheter is intended to be used in conjunct ....

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Quadrant Biosciences Receives Breakthrough Device Designation for Novel Autism Saliva Test

Quadrant Biosciences Receives Breakthrough Device Designation for Novel Autism Saliva Test
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SYRACUSE, N.Y., April 19, 2021 /PRNewswire/ Quadrant Biosciences Inc., a developer of novel molecular diagnostic tools, has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its innovative Clarifi ASD® autism saliva test.
Clarifi ASD is indicated for use in assessing the likelihood that a child has autism spectrum disorder (ASD) based on an evaluation of RNA epigenetic biomarkers in the saliva sample, as well as key patient characteristics. This novel test has the potential to substantially increase the efficiency of ASD identification, and lead to more rapid referral for early intervention services. ....

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FDA grants breakthrough device designation for atrial fibrillation ECG analysis platform

FDA grants breakthrough device designation for atrial fibrillation ECG analysis platform
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Sparta Biomedical Receives FDA Breakthrough Device Designation for SBM-01 Biomimetic Implant

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DURHAM, N.C., March 17, 2021 /PRNewswire/ Sparta Biomedical Inc., a developer of orthopedic solutions, today announced that its SBM-01 Biomimetic Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). SBM-01 is intended to replace damaged knee cartilage in patients having single or multiple chondral or osteochondral defects in the knee.
The Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatments for debilitating conditions. The Program provides patients and health care providers timely access to these medical devices by assisting sponsors in their development, assessment, and review, consistent with the FDA s mission to protect and promote public health. ....

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Apollo Endosurgery Receives FDA Breakthrough Device Designation for the Orbera(R) Intragastric Balloon for Treatment of Patients with NASH

Apollo Endosurgery Receives FDA Breakthrough Device Designation for the Orbera(R) Intragastric Balloon for Treatment of Patients with NASH
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