fda

Congressman Details Plans for Office of Wireless Health

Back in September of last year we reported that Representative Mike Honda (D-California) was going to introduce legislation to create an Office of Wireless Health within the Food and Drug…

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AliveCor’s iPhone ECG wins FDA Clearance

AliveCor has received 510(K) FDA clearance for its iPhone-based heart monitor. According to MobiHealthNews, the device will be available for pre-order by physicians via the company’s website immediately for $199.…

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Legislation Will Propose Office of Mobile Health

With the FDA due to issue regulations for mHealth products by the end of the year, Representative Mike Honda (D – Calif.) is planning to introduce legislation to establish an…

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FDA Has Cleared a Dozen mHealth Products Since May

It’s been a busy summer for the FDA when it comes to mobile health. In addition to the de novo clearance of the Proteus Digital Health ‘digital pill’ and of…

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23andMe’s 510(k) May Help Develop Regulatory Pathway for mHealth

By seeking a de novo 510(k) clearance from FDA, 23andMe may be leading the way in developing a straightforward, hopefully low cost, low burden regulatory pathway.
The 510(k) process is…

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Asthmapolis: Great Example of How to Integrate Mobile Technology

Asthmapolis is the kind of company we hope, and expect, to see more of in the future. They combine a straightforward device (a sensor that sits on top of asthma…

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Regulatory Path for Telehealth Consumer Devices Should be Simple

CellScope is the maker of mobile otoscopes and dermascopes. Two months ago they raised $1M from Khosla Ventures. As a telehealth consumer device this product should not require FDA approval.…

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Proteus Forges FDA Pathway

As we reported on Monday, Redwood City’s Proteus Digital Health has received FDA 510(k) premarket approval for its ingestible sensor. http://proteusdigitalhealth.com/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor/
What is particularly neat about this, other than the…

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Cybersecurity and Medical Devices

An article in the Journal PLoS reports that medical devices that rely on wireless technology to transmit data could be vulnerable to cyber attacks and urges improved federal monitoring of…

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When the “Grey Area” Between Medical Device, Consumer App is Just Fine

Is the $1.99 iPhone Cardiograph a medical device or a consumer app? The FDA will presumably let us know soon enough. But in the meantime it may not matter. It’s…

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