Fda Approves Medical-Image Software For Apple Mobile Devices

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Device Software Functions Including Mobile Medical …

https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications

Software functions for which the FDA intends to exercise enforcement discretion Does the FDA regulate mobile devices, such as smartphones or tablets, and mobile app stores? What are...

FDA approves iPad, iPhone radiology app for mobile …

https://appleinsider.com/articles/11/02/05/fda_approves_ipad_iphone_radiology_app_for_mobile_diagnoses

The US Food and Drug Administration has approved the first diagnostic radiology app for use in viewing medical images to make diagnoses using Apple's iPad …

Policy for Device Software Functions and Mobile …

https://www.fda.gov/media/80958/download

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Changes to Existing Medical Software Policies Resulting from …

FDA approves medical-image software for Apple mobile devices

https://www.latimes.com/health/la-xpm-2011-feb-05-la-na-fda-ipad-20110205-story.html

The Food and Drug Administration ushered in the era of mobile diagnostic radiology Friday, approving software for viewing images and making medical diagnoses …

Policy for Device Software Functions and Mobile Medical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications

Center for Biologics Evaluation and Research FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain …

FDA clears medical-image app for Apple mobile devices

https://www.massdevice.com/fda-clears-medical-image-app-apple-mobile-devices/

FDA clears medical-image app for Apple mobile devices February 5, 2011 By MedCity News The first medical app ever in the Apple Inc. (NSDQ: AAPL) app store …

8 AI Healthcare Startups with FDA-Approved Algorithms

https://www.nanalyze.com/2021/02/ai-healthcare-startups-fda-approved-algorithms/

There are currently about 60 FDA-approved AI-based algorithms and medical devices, according to a database compiled by The Medical Futurist. The technology first …

Medical Image Software for Apple Mobile Devices …

https://www.medindia.net/news/medical-image-software-for-apple-mobile-devices-approved-by-fda-80628-1.htm

The food and drug administration (FDA) has ushered in the era of mobile diagnostic radiology by approving a medical-image software for Apple mobile devices- …

Why Apple needed the FDA to sign off on its EKG but …

https://www.theverge.com/2020/10/7/21504023/apple-watch-ekg-blood-oxygen-fda-clearance

Apple went through a long, extensive process to develop and validate an EKG feature so that the watch could detect a condition called atrial fibrillation. It didn’t need to …

Does Your Mobile Medical App Need FDA Approval?

https://reinvently.com/blog/mobile-medical-application-approval-fda/

FDA Overview of Mobile Medical Applications – The FDA’s main website. FDA Guidance on its Regulation of Mobile Medical Applications (PDF) – Primary document referenced in this article. FTC …

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