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 MSN6d
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 ...
Yahoo Finance1d
QuantalX Secures FDA Clearance for its breakthrough Delphi stimulator, advancing direct brain health diagnosis at the point of care
Delphi-MD was granted FDA Breakthrough Designation Device status twice, the first for the detection of patients at risk for ...
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 ...
Medindia8d
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.
Business Wire13d
Imbed Biosciences Receives FDA 510(k) Clearance for Microlyte® Ag/Lidocaine
Imbed Biosciences receives FDA 510(k) clearance for first antimicrobial wound dressing with integrated lidocaine for painful ...
The University of Chicago Chronicle5d
In bioelectronics breakthrough, scientists create soft, flexible semiconductors
UChicago Pritzker Molecular Engineering study could lead to better brain-machine interfaces, biosensors, and pacemakers ...
Business Insider7d
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 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq ...
Morningstar12d
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 ...
Nasdaq7d
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 ...
manilatimes7d
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 ...