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 ...
Nasdaq5d
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 ...
Business Insider5d
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 ...
Synchron boss Tom Oxley hails Donald Trump’s ‘positive impact’ on medical devices
Tom Oxley, the Australian-born chief executive of brain chip company Synchron, has praised ­Donald Trump for having a ...
BioSpace13hOpinion
Opinion: Drugs Are Becoming ‘smarter.’ Here’s How
I have long held the belief that digital therapeutics will be prescribed alongside drugs to improve patient outcomes, leading ...
Medindia6d
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.
Woman's World on MSN4d
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 ...
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, ...
Aethlon Medical, Inc.: Aethlon Medical Reaches Key Milestone with Enrollment of the First Patient in (FPI) Its Hemopurifier Cancer Trial in Australia
Patient Enrolled at the Cancer Clinical Trial Unit, CALHN, Royal Adelaide Hospital Aethlon's Trial is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® ...
manilatimes5h
Ceribell Receives Authority to Operate from the U.S. Department of Veterans Affairs
The VA's National Tele-EEG program played a pivotal role in helping Ceribell achieve its ATO. The Tele-EEG program, which works to expand neurological care for veterans across the U.S., will manage ...