This morning at the FDA's public Workshop on its Mobile Medical Applications Draft Guidance, which it published in July, FDA senior advisor Bakul Patel noted that Medco had registered its smartphone ...
The requirements for Class 1 medical devices (medical devices with low risks and their safety and effectiveness can be ensured through routine administration) have been reduced to filing as opposed to ...
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.
CHICAGO--(BUSINESS WIRE)--Please replace the photo (for release dated July 28, 2014) with the accompanying corrected photo. The release reads: THERMO FISHER SCIENTIFIC LAUNCHES LC-MS-BASED CLASS I ...
Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from ...
HENDERSON, Nev.--(BUSINESS WIRE)--Aug. 21, 2006--Emergency Filtration Products Inc. (EFP) (OTCBB: EMFP) today reported that its NanoMask has been registered with the Therapeutics Goods Administration ...
ST. LOUIS, Dec. 12, 2019 (GLOBE NEWSWIRE) -- Today, Readout Health, a digital health company set to help millions of people manage their health through innovative and science backed breath technology, ...
The European Parliament this week formally agreed to delay the requirement for certain currently approved class 1 medical devices to comply with the new Medical Device Regulation (MDR) when it comes ...
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