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cyrus79

111 Posts.

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07/08/18

22:16

Post #: 34787235
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Originally posted by dman0 ↑

Mobile phones (and the mobile medical apps on them) are already classified as medical devices by the FDA.

From the FDA's own website "The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery"

https://www.fda.gov/medicaldevices/digitalhealth/mobilemedicalapplications/default.htm

Further, ResApp has already had a successful pre-submission meeting with the FDA to pursue approval by the De Novo Classification pathway. " The de novo pathway is designed for innovative medical devices (i.e.those which have no predicate device) where controls provide a reasonable assurance of safety and effectiveness."

The world has moved on from the stethoscope mate...it was invented 200 years ago in 1816 by two French dudes. Change is happening. In fact, it's fait accompli mate!

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the algo can be put into any form of listening device i m sure RAP will improve its delivery and uptake methods ... no doctors will want a 100 patient coughing into his/her 3 k handphone ...chill now we want to know if the algo works which im sure it does ...

RAP Price at posting: 20.0¢ Sentiment: Buy Disclosure: Held
2 Upvote

0 Great analysis

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