PROCEPT BioRobotics - PRCT

The AI bubble makes an appearance in the 510(k) clearance game.

An easy way for companies to circumvent the often long, arduous, and expensive route towards FDA approval for their drug or device is to claim it is “substantially equivalent” to something that either has already been approved or is something that was in existence prior to the time that particular FDA rule came into existence, which is 1976. Here’s a link to the FDA’s guide.

As an aside, it’s pretty crazy at the number of companies I have looked at over the years that have announced “new” 510(k) approvals based on a drug that has been around for over 100 years. So in other words, a 510(k) approval often doesn’t really mean all that much.

In the case of this $4.5B medical device maker, their recent 510(k) approval arrived less than 8 months after making their original filing with the FDA, which is considered lightning quick when you’re dealing with the FDA. With revenues already approaching 20% of their targeted market size, will this new approved device help them either gain more share or perhaps lead to expanding their targeted market?