Shares of robotic surgery pioneer Intuitive Surgical (ISRG -0.82%) are up 7.9% in 3:20 p.m. EDT trading Friday, a delayed but welcome reaction to some good news that came out Thursday.
Here's the story in a nutshell. Yesterday morning (a down day for the stock market, which may be why Intuitive stock didn't react to it), Goldman Sachs noted that medical products giant Johnson & Johnson has suffered a "major delay" to its robotic surgery program. First announced back in 2016, Johnson & Johnson's collaborative effort to build new "Verb" and "Auris" surgical robots in cooperation with Google won't be able to begin human trials before 2022, reports TheFly.com.
The news gets better (again, for Intuitive Surgical). According to Goldman, the FDA is going to require that applications for approval to market new surgical robots going forward seek premarket approval (PMA) rather than simply filing a 510(k) premarket notification of intent to market a new product. According to the FDA, a PMA is "the most stringent type of device marketing application required by FDA."
As the analyst tells it, this "stringent" regulation will pose "a major new barrier to entry for robotics," slowing down Johnson & Johnson, and Medtronic, and any other healthcare stocks that might wish to challenge Intuitive Surgical in this business.
After 25 years in business, Intuitive Surgical is already well-entrenched in the business of selling surgical robots -- to the point that Johnson & Johnson and Medtronic already had their work cut out for them trying to displace the incumbent whose name is most readily associated with the idea of robotic surgery.
New regulations from the FDA, and unforced errors of the sort Johnson & Johnson apparently just made, won't make their jobs any easier. This amounts to a "significant positive" for Intuitive Surgical, in Goldman Sachs' view -- and I cannot disagree.