FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 ...
Woman's World on MSN3d
Study: At-Home Device Eases Depression Symptoms for 50%
With nearly 20 percent of U.S. adults affected by depression, the prevalence of this mental health condition drives many to ...
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New device delivers antibiotics directly to wounds in dogs and horses
The Vetlen Pouch can be placed in infected wound sites and can continuously deliver medication for up to 30 days ...
SeaStar Medical announces BDD from U.S. FDA CBER for SCD
SeaStar Medical (ICU) announces the receipt of a Breakthrough Device Designation, BDD, from the U.S. Food and Drug Administration’s, FDA, ...
Envoy Medical receives FDA approval to initiate study for hearing device
Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted ...
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AWAK’s Portable Dialysis Device Offers New Hope for Kidney Patients
What if kidney dialysis was portable? AWAK Technologies’ wearable PD device enters trials, promising freedom and comfort for end-stage kidney patients.
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Heartlung Receives FDA“Breakthrough” Marketing Authorization For First AI To Detect Hidden Heart Disease In CT Scans
The FDA Breakthrough Device designation for AutoChamberTM follows the FDA's recent clearance of HeartLung's AutoBMDTM, an AI-powered opportunistic bone density measurement test that works on any ...
studyfinds12d
$3 paper device could accurately detect cancer in 60 minutes
Researchers reveal how a new breakthrough could make early cancer detection more accessible and affordable worldwide.
Business Wire10d
Dassault Systèmes Collaboration Yields Breakthrough Guide for Using Virtual Twins in Clinical Trials
Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA) today announced the availability of the world’s first guide for the ...
The University of Chicago Chronicle1d
In bioelectronics breakthrough, scientists create soft, flexible semiconductors
UChicago Pritzker Molecular Engineering study could lead to better brain-machine interfaces, biosensors, and pacemakers ...
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FDA Grants Breakthrough Device Designation for SeaStar Medical's Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
"This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA's continued recognition of the SCD's potential to save lives and improve patient ...
Morningstar9d
Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
“Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss ...