Patel noted that the app is registered as a Class 1 medical device, which means it is among the lowest-risk medical devices. Much of the discussion at this week's workshop centered on to what extent ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

Last fall, a group of experts advising the U.S. Food and Drug Administration debated for two days on how to regulate generative artificial intelligence tools in medicine. One report presented at the ...

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...

GUELPH, ON / ACCESSWIRE / November 27, 2024 / Zentek Ltd. (ZTEK) ("Zentek" or the "Company")(TSX-V:ZEN), an intellectual property development and commercialization company, announces its decision that ...

WEST LAFAYETTE, Ind. – A device that makes it faster and more convenient to collect and process blood samples has been registered by the U.S. Food and Drug Administration (FDA) as a Class 1 Medical ...

iMDsoft announced recently that the FDA has listed myAnesthesia as a class one medical device. myAnesthesia is a cloud-based iPad app that provides electronic documentation for anesthesia procedures.

Medtronic, battered by a high number of serious medical device recalls in recent years, says it is toughening its internal assessments for acquiring new products. The company, operationally based in ...

All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...

The 2023 State of Cybersecurity for Medical Devices and Healthcare Systems report, a collaboration of the Health Information Sharing and Analysis Center with Securin and Finite State, examined the ...