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STAT2dOpinion
The FDA is embracing AI boldly. Now it must show what responsible innovation looks like
If mishandled, this move could undermine public trust in the FDA and squander a once-in-a-generation opportunity to lead the ...
Medical Device Network on MSN2d
FDA grants breakthrough device status for Elucent’s EnVisio X1 system
The EnVisio X1 platform is currently under development stage and unavailable for sale or clinical usage in the US.
Medical Device Network on MSN12d
The FDA’s Final Rule on LDTs: gone for good?
The Final Rule was mooted for implementation over a staged transition period, determined by a service’s risk level, by 2028.
STAT2d
FDA clears first blood test for diagnosing Alzheimer’s
The FDA has approved the first blood test for diagnosing Alzheimer’s disease, which could speed the path to treatment for ...
Medical Device Network on MSN6d
Teal Health gains FDA approval for cervical cancer screening device
The FDA has granted approval to Teal Health’s at-home vaginal sample self-collection device, Teal Wand, for cervical cancer ...
FDA greenlights marketing of first Alzheimer's blood test for some patients
Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...
InsideHook on MSN4h
The FDA Just Approved an Alzheimer's Disease Blood Test
If you or someone you love is concerned about Alzheimer’s disease, the process of detecting its presence can involve a series ...
JD Supra13d
Distribution Chain Compliance for Medical Devices
Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements ...
ABC Action News2d
FDA gives green light to new blood test that screens for Alzheimer's
The U.S. Food and Drug Administration on Friday cleared the first blood test for the diagnosis of Alzheimer's disease.
FDA OKs first blood test that can help diagnose Alzheimer’s disease
The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker ...
TechBullion1d
John Emmert FDA Investigator Profile: Warning Letters and Inspection Outcomes
FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...