Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
JD Supra11d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Hoodline6h
Mokena-Based Medical Device Company AIM to Pay $1 Million to Settle Federal Fraud Allegations
AIM, a medical device company, agrees to a $1 million fine to settle a federal fraud probe over misbranded gear.
Hosted on MSN3d
FDA tags Sentec/Percussionaire’s breathing circuit recall as Class I
The US Food and Drug Administration (FDA) has tagged a recall of breathing circuits manufactured by Sentec/Percussionaire as ...
The Taipei Times13d
‘Medical devices’ cannot be resold, the FDA says
Some products bought in pharmacies, including tampons and adhesive bandages, are listed as “medical devices” in Taiwan and ...
Hosted on MSN2d
FDA Warns People About The Serious Consequences Of Missed Notifications for Diabetes Patients
In this new age of technology, our lives have become heavily tangled with our electronics. Even when it comes to alerts about ...
FDA shares warning on some smartphone-connected diabetes devices
According to the CDC, more than 38 million Americans have diabetes. This warning is for people who use diabetes apps like continuous glucose monitors, insulin pumps, and other diabetes management ...
medtechdive2d
Judge orders FDA, health agencies to restore removed webpages
District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking ...
healthday3d
Wrong Smartphone Settings Can Lead to Missed Alerts From Linked Diabetes Devices
The U.S. Food and Drug Administration is urging all patients with smartphone-compatible diabetes devices to check the ...
JD Supra2d
CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released ...
Morningstar10d
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
the U.S. Food and Drug Administration is alerting patients of a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing ...