4 ms·

Amazing, seeing how you as a doctor could think of processes that you do, and conceptualize it in software! Congratulations on the launch, and I wish you well,

Amazing, seeing how you as a doctor could think of processes that you do, and conceptualize it in software! Congratulations on the launch, and I wish you well, and hope it is of great use to thousands! > existing FDA-cleared hardware Can you please link to this?

rnavara 5y ago
Thanks so much! Medicine is often a mix of extremely high tech and very low tech, so we're in a great position to fix the latter :) We can actually pair with multiple different types of hardware (our software is hardware-agnostic) but we have a couple preferred hardware devices. One of which is https://www.kardia.com/kardiamobile6l/ https://www.kardia.com/kardiamobile6l/
- bradknowles 5y ago
  Sold! Now, how do I also get your software that will work with this hardware?
  - Rssnkgp02 5y ago
    Software still needs to pass its FDA clearance, but great to hear your interest!
- OJFord 5y ago
  So you recommend their hardware, and compete with them on software? (Assuming I understood that correctly -) what stops them catching up/replicating your (presumably) better software? Or perhaps more to the point - the problem you mention in OP seems, as described, like it's already solved by Kardia, what was missing that you had to build?
  - rnavara 5y ago
    Great point, indeed the problem of automated ECG analysis has been around for the last several decades and there's still no automated solution accurate for AFib patients (one of the the hardest categories for making ECG measurements). Our software is specifically trained on AFib ECGs and our specific focus of this market and guiding drug dosing, as well as our clinical expertise in the field gives us our edge. It's a similar reason why startups can do things that Google and Amazon can't :)
neurotech1 5y ago
They are referring to 510(k) Clearance [0] > The 510(k) Clearance process is one of two ways by which a medical device manufacturer can obtain approval from the Food and Drug Administration, although legally, a device clearance under this section is not a true “approval.” 510(k) Clearance simply gives the company permission to market its product, based on comparison to a “predicate” [previously approved] device.[1] Basically, If a somewhat similar device is already on the market, the FDA will clear the new device for the market. [0] https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances https://www.fda.gov/medical-devices/device-approvals-denials... [1] https://www.levinlaw.com/fda-510k https://www.levinlaw.com/fda-510k
- Rssnkgp02 5y ago
  Excellent, yes - thank you for listing these. EKG devices have been around for a long time, so plenty of predicates for 510(k) pathway.

rnavara 5y ago

Thanks so much! Medicine is often a mix of extremely high tech and very low tech, so we're in a great position to fix the latter :) We can actually pair with multiple different types of hardware (our software is hardware-agnostic) but we have a couple preferred hardware devices. One of which is https://www.kardia.com/kardiamobile6l/ https://www.kardia.com/kardiamobile6l/

bradknowles 5y ago
Sold! Now, how do I also get your software that will work with this hardware?
- Rssnkgp02 5y ago
  Software still needs to pass its FDA clearance, but great to hear your interest!
OJFord 5y ago
So you recommend their hardware, and compete with them on software? (Assuming I understood that correctly -) what stops them catching up/replicating your (presumably) better software? Or perhaps more to the point - the problem you mention in OP seems, as described, like it's already solved by Kardia, what was missing that you had to build?
- rnavara 5y ago
  Great point, indeed the problem of automated ECG analysis has been around for the last several decades and there's still no automated solution accurate for AFib patients (one of the the hardest categories for making ECG measurements). Our software is specifically trained on AFib ECGs and our specific focus of this market and guiding drug dosing, as well as our clinical expertise in the field gives us our edge. It's a similar reason why startups can do things that Google and Amazon can't :)

neurotech1 5y ago

They are referring to 510(k) Clearance [0] > The 510(k) Clearance process is one of two ways by which a medical device manufacturer can obtain approval from the Food and Drug Administration, although legally, a device clearance under this section is not a true “approval.” 510(k) Clearance simply gives the company permission to market its product, based on comparison to a “predicate” [previously approved] device.[1] Basically, If a somewhat similar device is already on the market, the FDA will clear the new device for the market. [0] https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances https://www.fda.gov/medical-devices/device-approvals-denials... [1] https://www.levinlaw.com/fda-510k https://www.levinlaw.com/fda-510k

Rssnkgp02 5y ago
Excellent, yes - thank you for listing these. EKG devices have been around for a long time, so plenty of predicates for 510(k) pathway.