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 ...
Nearly 100,000 bottles of nasal spray recalled for 'microbial failure'
Almost 100,000 bottles of nasal spray were recalled for a "microbial failure" that led to multiple complaints from customers.
healthday4d
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 ...
The National Law Review6d
FDA Issues Draft Guidance on Managing Cybersecurity Risks Affecting AI-Enabled Devices
On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...
J&J resumes US rollout of Varipulse heart device after investigation
Johnson & Johnson said on Friday it resumed the limited market release of its Varipulse heart device in the United States ...
The National Law Review4d
CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices
Contec Medical Systems (“Contec”), a global medical device and healthcare solutions company headquartered in China, sells ...
Renal & Urology News4d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
The FDA has issued a safety communication regarding the potential for missed alerts with diabetes devices due to software or hardware changes.
medtechdive3d
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 ...
Healthcare Dive4d
Former FDA head Gottlieb calls for less regulation of certain AI tools
Scott Gottlieb supports a reversion to an earlier interpretation of the 21st Century Cures Act, which would exempt more types ...
Illegal vapes flood U.S. market as FDA struggles to squeeze out illicit products
Take a walk to your local smoke shop and look at the labels. The U.S. Food and Drug Administration only allows retailers to ...
Family whose 5-year-old was killed in a hyperbaric chamber is ‘absolutely devastated,’ attorney says
Thomas Cooper’s parents hoped the oxygen therapy he was receiving at a facility in Troy, Michigan, would help his sleep apnea ...
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 ...