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And given that the major competitors will only be applying for...

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manuva13

79 Posts.

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17/12/16

21:12

Post #: 21414038
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Originally posted by imback ↑

What I was trying to explain in my last sentence was that interpretation and diagnosis software has and always will be regulated. It hasn't changed the hurdle for competitors.

It is a little convoluted, but this law change is only formalising the process for software which doesn't interpret and diagnose.

I spent 2 weeks studying back in 2011 when the FDA first proposed it as it was going to affect one of my company's products. Fortunately the the FDA changed their mind and this law now formalises that position change.

The denovo route LBT took will hopefully give them some protection from a competitor using the shorter 510k route as it is rarely allowed after a denovo. The only thing that concerns me is if they created a new category, will that help a competitor to use it for the 510k route. Not sure on that one.

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And given that the major competitors will only be applying for approval on upgrading existing software/hardware that is already being used in laboratories they'll have a much shorter route to take and a far greater capacity to generate data to support their case

LBT Price at posting: 32.0¢ Sentiment: Buy Disclosure: Held
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