Momentis Built Its Own Predicate, Then Spent It Three Times

Momentis Surgical said on July 23 that the FDA cleared a multiport configuration of its Anovo system, and the company can now claim something no other surgical robot can: natural orifice, single-port, and multiport access on one platform. The capability is the headline. What interests me is the regulatory decision that made it possible, which Momentis made years earlier, back when it looked like the slower option.

Anovo's original authorization was a De Novo for a robotic transvaginal surgical system. No predicate existed, because the category didn't. Momentis had to define what the device was, name what could go wrong with it, and decide what testing would prove it safe enough. That is more work than pointing at somebody else's cleared robot and arguing you're close enough to ride along.

What that bought them shows up in every filing since. Each one has been a 510(k) against a predicate they own. Single-site transabdominal ventral hernia repair. Robotic camera control. Now the multiport configuration, which puts gynecologic procedures and ventral hernia repair on the same core platform across different access approaches. Three expansions, each one a routine submission, because the hard categorical argument got settled once.

I lost this argument from the other side

At Galen we were building a cooperative-control robot for skull-base and laryngeal surgery. Cooperative control means the surgeon is still driving. It's a joystick, not a remote. We thought we had a clean 510(k), and we shared some software lineage with the da Vinci, since Russ Taylor wrote the original code. The predicate logic looked airtight from where we sat.

The FDA didn't buy it. Our indication didn't match, they said, and a Delta robot isn't a remote-control telemanipulator. We pushed back and they said no again. Then came the sentence you have to learn to hear: it would be advisable that we consider the De Novo path. That's not a suggestion. That's the answer.

So we took it, and the work turned into framing. We stopped arguing that we were a da Vinci and anchored the indication in what was physically happening, which was stabilizing an instrument the surgeon was already holding at the end of a 40-centimeter shaft. We drafted the proposed regulation ourselves. The FDA took our language essentially word for word, and Galen became the predicate.

The sequencing is the part that matters. We got there by losing first.

Your first clearance is inventory

Founders treat the first clearance as a finish line, and the whole company organizes around clearing anything at all as fast as it can. That's the wrong thing to optimize. The first clearance is inventory you'll spend for the next decade, and its value sits almost entirely in what it lets you file next.

A De Novo looks expensive on the first pass and cheap on the fourth. You write the safety story instead of guessing at somebody else's, because you don't have their submission and never will. The regulation that comes out the other side describes your device, which means later entrants have to be substantially equivalent to you, and your own next feature becomes a clean filing against yourself. A borrowed predicate gives you none of that. It gives you a faster first clearance and a ceiling.

The other thing is where Momentis started clinically. It didn't open by trying to be a cheaper da Vinci. It opened in transvaginal procedures, a place the incumbent console-and-cart geometry serves poorly, and worked outward from there. Those two decisions aren't separate ones. Picking a procedure the existing category handled badly is what put a new device classification on the table at all, and walking into the agency asking permission to be somebody else would have closed that door.

One caution before anyone reads this as a template. A De Novo is only on the table when the agency already considers your risk moderate and manageable. If they think you're high risk you're in a PMA, and no amount of clever framing rescues that. The pathway isn't something you pick in a conference room. It's a read you take off the signals the agency gives you, and reading those signals correctly is most of the job.

Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →