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Medical Device Network on MSN3d
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.
MedTech Dive20h
FDA, aiming to speed scientific reviews, names chief AI officer
Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA ...
In reversal, FDA rehires staff tasked with releasing public records
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
RFK’s FDA layoffs could slow safety communications, experts warn
The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety ...
Ticker: First at-home test kit for cervical cancer approved by the FDA; Panasonic cuts 4% of its global workforce as profits falter
Ticker: First at-home test kit for cervical cancer approved by the FDA; Panasonic cuts 4% of its global workforce as profits falter ...
STAT10d
How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
JD Supra4d
Distribution Chain Compliance for Medical Devices
Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements ...
MassDevice13d
FDA says recall of Abbott HeartMate power unit is serious
This marks the latest recall-related issue for HeartMate in recent years. Last June, the FDA deemed another recall as serious ...
Rolling Out1d
FDA warns of dangers in finasteride hair loss treatments
Recent FDA alert reveals concerning side effects of topical finasteride hair treatments that may persist long after stopping ...
STAT1d
New CBER Director Vinay Prasad praises evidence, FDA reviewers in first speech to staff
WASHINGTON — In his first address to FDA staff on Wednesday, Vinay Prasad emphasized his commitment to evidence, his ...
MassDevice2d
FDA clears more BrightHeart AI capabilities in fetal heart ultrasound
BrightHeart has its second FDA clearance for updates to its platform, an AI-powered digital screening tool for congenital ...
Becker's Hospital Review4d
FDA rehires more staff: 3 things to know
The FDA has reinstated additional employees who were previously laid off amid a broader restructuring effort, KFF Health News reported May 2. HHS began issuing dismissal notices April 1 as part of a ...