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CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
Becker's Spine Review3d
7 spine, orthopedic devices earning FDA clearance in 1 month
Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.
Becker's Hospital Review3d
3 medical device recalls
Here are three recent recalls reported to the FDA: ...
Becker's Hospital Review3d
FDA spotlights risks in medical device supply chain
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.
Hosted on MSN5d
Top 5 Small-cap Medical Device Stocks (Updated January 2025)
The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device ...
JD Supra5d
FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...
ophthalmologyadvisor5d
FDA Alerts: Ophthalmology Drug and Device Approvals
FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.
Radical Catheter Technologies’ 8F Neurovascular Catheter Receives US FDA 510(k) Clearance, Second for the Best-in-Class Ribbon Technology Platform
I am pleased with the growth and accomplishments related to the Company’s key strategic objectives to set a new standard in neurovascular access and delivery,” said Brian Martin, co-founder and CEO of ...
Modern Healthcare6d
Philips recalls remote cardiac monitoring software after 2 deaths
The Food and Drug Administration announced that Philips recalled the software following 109 reported injuries and two ...