Hosted on MSN18h
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 ...
medtechdive6d
FDA labels recall of discontinued Olympus endoscope part as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
JD Supra5d
BIS Increases Export Controls on Key Biotech Equipment
BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export ...
XL Bully bites officer during dawn raids on drug-dealing network around Dover
An XL Bully bit a police officer during one of seven dawn raids this morning designed to smash a criminal network.
GlobalData on MSN2d
Spectral AI concludes burn study data analysis of DeepView system
Spectral AI has completed the data analysis for its pivotal Burn Study, in the US, designed for the validation of its DeepView System's artificial intelligence (AI)-powered algorithm for burn ...
The National Law Review2d
FDA Issues Draft Guidance on Managing Cybersecurity Risks Affecting AI-Enabled Devices
On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...
The National Law Review21h
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 ...
Cookies Recall Update as FDA Sets Risk Level
The U.S. Food and Drug Administration (FDA) has given its second most serious risk level, Class II, to a product from D. Coluccio & Sons. The recalled product is a 300 gram pack of chocolate chip ...
medtechdive1d
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 Century Cures Act.
Indiatimes4d
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 missed critical alerts. Issues arise from software configuration ...
Local 12 WKRC Cincinnati6d
FDA clears migraine device for children as young as 8
The device was recently cleared by the FDA for use in children as young as eight to alleviate headaches due to migraines. Savannah described the device's effectiveness. "I can just wear it for 45 ...