Problems with pulse oximeters have been known for decades, but it wasn’t until the pandemic that the real dangers to Black ...
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
Here are three recent recalls reported to the FDA: ...
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.
The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...
How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...
A Maryland Heights-based manufacturer of drug-delivery devices won a multimillion-dollar federal contract to produce a ...
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FDA grants IDE approval for NextBioMedical’s Nexsphere-F trialThe US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's ...
It's been over a decade since the Fitbit was first introduced, and more companies have entered the market for wearable health ...
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