Cryptopolitan on MSN5d
FDA’s new device chief faces growing pressure as AI and tech transform healthcare
Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...
Yahoo1d
LED device treats leading cause of vision loss with light therapy, FDA says
A device that beams light into the eyes can improve the sight of people with a leading form of vision loss, known as ...
US FDA approves Johnson & Johnson's device for heart condition
The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal ...
BioPharma Dive8d
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on ...
What awaits Harris or Trump at the FDA
The FDA faces policy challenges as technological advances roil health care and the agency fights for resources from Congress — no matter who wins the election.
STAT7d
Lawsuit to fix pulse oximeter bias makes progress with device manufacturers
A lawsuit against pulse oximeter manufacturers and distributors is starting to create change. But experts say the FDA needs ...
Becker's Spine Review3h
Foundation Surgical earns FDA nod for Vertiwedge device
Foundation Surgical earned FDA 510(k) clearance for its Vertiwedge intraosseous device, according to a Nov. 8 news release shared with Becker's ...
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 FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
www.hks.harvard.edu9d
A human-algorithm approach to approving medical devices could slash the recall rate and save billions
A new process that consolidates machine learning algorithms with unique human-based expertise promises to improve the regulatory and approval process for new medical devices by reducing the recall ...
MedPage Today20h
Patients With Obesity Shed Pounds With Drug-Free Capsule
The Epitomee capsule -- which was cleared by the FDA in September for weight management -- is a novel shape-shifting device ...
MassDevice8d
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
The Future Of Brain-Computer Interfaces Emerges At Mount Sinai
Summary of Mount Sinai's New York BCI Symposium, by Synchron and Precision Neuroscience. Market Trends and forecast for brain ...