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The National Law Review
3 天
FDA Issues Draft Guidance on Managing Cybersecurity Risks Affecting AI-Enabled Devices
On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...
2 小时
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 ...
The National Law Review
2 天
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 ...
healthday
1 天
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 ...
Renal & Urology News
2 天
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.
6 天
Are smartphone diabetes devices putting lives in danger? US FDA sounds alarm
The US FDA warns users of smartphone-linked diabetes devices like CGMs and insulin pumps of potential health risks due to ...
Modern Healthcare
3 小时
GE HealthCare doubles down on AI with new devices, acquisitions
During the company's fourth-quarter earnings call Thursday, Arduini said the company has no plans to slow down. During the ...
medtechdive
22 小时
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 ...
aha.org
5 天
FDA warns of potential to miss notifications on smartphone-compatible diabetes devices
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...
medtechdive
2 天
Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st ...
Sierra Sun Times
5 天
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When ...
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible ...
Health and Me on MSN
1 小时
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 ...
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