Digitalhealthconsult.com

Digital Health Consult – Navigate your digital health product free …

WebDigital Health Consult can advise your digital health company with any of the following services that may apply to your product. 1 If a non-FDA regulated product is a desired …

Actived: 3 days ago

URL: https://digitalhealthconsult.com/

What does FDA intend to regulate and what does that mean for …

WebThe FDA issued final guidances applicable to digital health products on mobile medical applications (MMA) and medical device data systems (MDDS) in …

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Steps – Digital Health Consult

WebCONTACT INFORMATION Digital Health Consult 754 NW Broadway, Suite 206 Bend, OR 97703 [email protected] Follow us @dhealthconsult:

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AI Enabled Medical Devices with Recent FDA De Novo or 510(k) …

WebMedical device makers have seen a productive summer with warm receptions at FDA for Artificial intelligence (AI) enabled devices. Over the last five weeks, a number …

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Services – Digital Health Consult

WebFDA guidances applicable to digital health products on mobile medical applications (MMA), general wellness products (GWP), clinical decision support software (CDSS) and …

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About – Digital Health Consult

WebCONTACT INFORMATION Digital Health Consult 754 NW Broadway, Suite 206 Bend, OR 97703 [email protected] T + 503-758-4964. Follow us @dhealthconsult:

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FDA Warning Letter Issued for Non-Validated AI Code Claimed …

WebFDA recently issued a warning letter to Wavi that claimed its AI code used for its Wavi Desktop product was “for research use only” and not subject to FDA regulation. …

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The impact of Fitbit IPO on digital health

WebThe dust has settled after the successful IPO of Fitbit (NYSE: FIT), who can accurately be described as the world’s largest wearables maker.Fitbit raised …

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The New Launchpad for Mobile Medical Device Apps: the …

WebThere was a time not too long ago when medical devices were launched to the world almost exclusively at preeminent medical society meetings, primarily to gain the …

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Theranos and the FDA: A Cautionary Tale on the Need for …

WebA flurry of recent reports in the Wall Street Journal, New York Times, Forbes and Reuters regarding Theranos states it is using an unapproved medical device, not …

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IBM’s Watson to “See” Clinical Imaging Data with $1B Acquisition …

WebIBM (NYSE: IBM) announced yesterday that Watson will gain the ability to “see” by uniting Watson’s advanced image analytics and cloud-based cognitive …

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Follow-up On AI Enabled Medical Devices with Recent De Novo

WebTwo devices with recent De Novo Classifications were reported on recently in the Viz.ai HCM and Better Therapeutics devices that employ Artificial Intelligence (AI) …

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Commentary on Draft FDA Guidance titled “Best Practices for …

WebOn September 6th, 2023, the FDA released three draft guidances with the stated of goal of “…Part of Ongoing Efforts to Modernize the Premarket Notification [510(k)] Program”. I …

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Enforcement Policies – Digital Health Consult

WebIn March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus …

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The Flex Company – Digital Health Consult

WebCONTACT INFORMATION Digital Health Consult 754 NW Broadway, Suite 206 Bend, OR 97703 [email protected] Follow us @dhealthconsult:

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Fitbit Announces HIPAA Compliance for Wellness Platform

WebFitbit (NYSE: FIT) announced last Wednesday that it is adding HIPAA compliance protocols related to its privacy and security for its Fitbit Wellness division. …

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IBM buys Truven for $2.6 Billion, now has Health-Related Data on

WebIBM (NYSE: IBM) announced last month that Watson Health will gain the ability to analyze the cost and treatment data on more than 200 million patients with the …

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Contact – Digital Health Consult

WebCONTACT INFORMATION Digital Health Consult 754 NW Broadway, Suite 206 Bend, OR 97703 [email protected] Follow us @dhealthconsult:

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May 2015 – Digital Health Consult

WebCONTACT INFORMATION Digital Health Consult 754 NW Broadway, Suite 206 Bend, OR 97703 [email protected] T + 503-758-4964. Follow us @dhealthconsult:

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