Medical devices & diagnostics · Surgical robotics
Andromeda Surgical
A tablet-driven robot that guides urologists through one of the hardest operations in their specialty. Licensed in Canada in July 2026, used in more than 40 patients by the company’s count, and not cleared by the FDA for anything.
A tablet in the operating room
On December 19, 2024, in an operating theatre at Universidad Católica in Santiago, Chile, Dr. Cristián Trucco removed an enlarged prostate through the urethra with a holmium laser. The unusual part was not the laser. It was that he drove the instruments from a tablet.
The company behind the machine, Andromeda Surgical, was eighteen months old. Its robot is a single arm holding the scope and the laser fibre, wrapped in software that tells the surgeon where inside the prostate the tip sits.
“This case was the first robotic-assisted HoLEP procedure in history, and as far as we know, the first surgery performed using a tablet,” said co-founder and chief executive Nick Damiano in the announcement. That case opened a registered study the company calls ASTRA.
Two years on, the platform carries a Canadian device licence, a $15 million Series A and claims running well ahead of the paperwork.
The operation almost nobody performs
Holmium laser enucleation of the prostate, shortened to HoLEP, peels the obstructing tissue out whole rather than shaving it away, and works on prostates of almost any size. Peter Gilling and Mark Fraundorfer developed it in New Zealand in the late 1990s.
It is also hard. Andromeda’s own launch release notes that “a steep learning curve has limited its adoption”. The published literature agrees. A 2021 series of 100 consecutive cases from Turkey concluded that “HoLEP still has a steep learning curve. It is necessary to reach the number of cases of 25-50 to reach fundamental experience.” Most urologists never get there, so most patients never get offered it.
Andromeda reads that gap as a cognitive problem, not a mechanical one. The surgeon has to know, continuously and without a map, where the plane between adenoma and capsule lies. Its Y Combinator launch post says the company has “designed a GPS-like location system to help surgeons accurately orient themselves and perform the best possible action in every moment.” The arm is deliberately unremarkable. The navigation is the product.
A medtech founder and a driverless truck engineer
Nick Damiano studied engineering at Stanford and came out of the Stanford Biodesign fellowship. He co-founded Nurep, later Avail MedSystems, which built remote support for operating rooms and whose technology Mendaera acquired in March 2024. He then founded Zenflow, a minimally invasive implant for the same prostate condition Andromeda now targets, and took it through Y Combinator in Winter 2015.
Kartik Tiwari came from the other side. At Starsky Robotics, a Y Combinator company from Summer 2016, he led the team that put an unmanned truck on a live highway. The two met through Y Combinator co-founder matching and started Andromeda in 2023.
Their thesis is that an operating room is easier to automate than a road: the anatomy can be mapped, the instruments are standard, and a surgeon watches every move. “Surgery is a $3.7 trillion global market, and a better application for autonomy than driving,” Damiano told one outlet.
First case, first partners, first licence
Gilling, who helped invent HoLEP, signed on as lead principal investigator of ASTRA, and enrolment opened in New Zealand in early 2025. In March 2025 the company announced supply partnerships with Richard Wolf, the German endoscopy maker, and Quanta System, the Italian laser firm owned by El.En. The same release reported 15 procedures in Chile and New Zealand.
In 2025 it was selected for the American Urological Association’s Innovation Nexus Showcase. A second study registration, NCT07741656, took its first patient on September 26, 2025.
Then the regulatory record moved. On July 21, 2026, Health Canada issued device licence 115817 for the BEACON PLATFORM, a Class II system, to Andromeda Surgical, Inc. of South San Francisco. Two weeks later, on August 3, the founders announced a $15 million Series A led by Standard Capital, taking reported total funding to $30 million, with the company saying its first commercial systems would be installed within two months.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA status | No 510(k), De Novo or PMA record for Andromeda Surgical or Beacon as of September 22, 2026. Nothing is cleared for sale in the United States. | Public record |
| Health Canada licence | Licence 115817, BEACON PLATFORM, Class II, type System, first licence status date July 21, 2026, no end date recorded. Queried September 22, 2026. | Public record |
| How the registry describes it | The trial record calls Beacon “a robotically assisted surgical (RAS) device” that lets the urologist control instruments through software. Nothing in the registered protocol is autonomous. | Public record |
| Autonomy, as marketed | The company calls the category autonomous surgical robots on its website, its Y Combinator listing and its AUA entry, while describing surgeon-in-the-loop autonomous tasks as in development. | Claim ahead of record |
| ASTRA study, as registered | NCT06668142, single-arm open-label, 54 patients estimated, started December 12, 2024, recruiting. Primary endpoints: completion without conversion, and adverse events of Clavien-Dindo Grade 3a or higher through 30 days. Three sites in Chile and New Zealand. Primary completion estimated December 30, 2026. | Public record |
| Second registration | NCT07741656, interventional, 50 patients estimated, first patient September 26, 2025, recruiting. | Public record |
| Patients treated | 15 procedures by March 2025, then more than 40 patients in three countries by the 2026 Series A. The registry lists two countries; the third is not named in any public record. | Company-stated |
| Speed claim | Enucleation as fast as 30 minutes against a published average of roughly 90. No citation is given for the comparison figure. | Company-stated |
| Peer-reviewed papers | No PubMed results for Andromeda Surgical or the Beacon platform as of September 22, 2026. | Not found |
| Commercial availability | RuntimeWire reported in August 2026 that the company website says “Beacon is not commercially available and has no regulatory approval in the US or any other country”, the same week investors were told it had clearance to launch in Canada and New Zealand. | Site and release differ |
| Partnerships | Richard Wolf and Quanta System, March 2025. No deployment or revenue figures published. | Partner-stated |
| Federal grants | No NIH or NSF award to Andromeda Surgical found. | Not found |
Read plainly: Beacon is a real device used in real patients, and a Canadian regulator has now put its name on a licence. Autonomy is still a roadmap. The word matters here, because the FDA has spent a decade insisting on the distinction. Its guidance page says flatly that “The device is not actually a robot because it cannot perform surgery without direct human control.” A 2024 review in npj Digital Medicine of 49 robots cleared between 2015 and 2023 found that “Most surgical robots were at Level 1 (86%) and some reached Level 3 (Conditional Autonomy) (6%).” No cleared device performs surgery by itself, and Andromeda has not asked the FDA to clear one.
What to watch
- ASTRA results against the registered endpoints: conversion rate and Clavien-Dindo Grade 3a or higher events, primary completion estimated December 30, 2026.
- Which FDA pathway it chooses, 510(k) or De Novo, and whether the first submission covers navigation only.
- Whether the Canadian licence turns into named hospitals, promised for about October 2026.
- The third country behind the 40 patient figure, and the first peer-reviewed report of Beacon cases.
- What NCT07741656 is for. A second 50 patient study beside a 54 patient pilot usually signals a pivotal trial forming.
In their words
“This case was the first robotic-assisted HoLEP procedure in history, and as far as we know, the first surgery performed using a tablet.”
Nick Damiano, co-founder and CEO, December 2024 release · Company release
“I believe new technologies that provide navigational guidance in HoLEP may help urologists shorten the learning curve by enhancing the recognition of key anatomical landmarks.”
Dr. Rodrigo Ledezma, co-principal investigator, Universidad de Chile, December 2024 release · Company release
“At Andromeda Surgical, we are moving at an unprecedented pace to redefine the future of robotic surgery.”
Nick Damiano, March 2025 partnership release · Company release
“Andromeda Surgical is bringing a groundbreaking approach to robotic-assisted surgery, and we are thrilled to be part of this journey.”
Jürgen Steinbeck, Co-CEO, Richard Wolf, March 2025 · Partner-stated
“Globally, five billion people lack access to safe, affordable surgical care when they need it.”
Nick Damiano, to The Silicon Valley Post, 2026 · Independent
“Surgery is a $3.7 trillion global market, and a better application for autonomy than driving.”
Nick Damiano, to The Silicon Valley Post, 2026 · Independent
“It’s hard to imagine a team better suited to bring autonomy into surgery, which is why we backed them at seed and why we increased our position in this round.”
Abdullah Al Shaksy, co-founder and CEO, Phaze Ventures, August 2026 · Investor
Related companies
Sources
- Public recordClinicalTrials.gov NCT06668142, Beacon Platform for HoLEP
- Public recordClinicalTrials.gov NCT07741656, Beacon Platform for HoLEP
- Public recordHealth Canada MDALL, device licence 115817, BEACON PLATFORM
- Public recordFDA 510(k) and PMA searches, no Andromeda Surgical record
- Public recordComputer-Assisted Surgical Systems guidance page
- Public recordForm D filings by three vehicles naming Andromeda Surgical
- IndependentLevels of autonomy in FDA-cleared surgical robots: a systematic review
- IndependentDoes Holmium laser enucleation of the prostate still have a steep learning curve?
- IndependentAndromeda Surgical announces first robot-assisted prostate procedures
- IndependentAndromeda Surgical raises $15 million to push autonomy into prostate surgery
- IndependentAndromeda Surgical raises $15 million Series A for autonomous surgery
- InvestorAndromeda Surgical raises $15M Series A led by Standard Capital
- CompanyAndromeda Surgical announces world’s first robotic-assisted HoLEP procedure
- CompanyStrategic partnerships with Richard Wolf and Quanta System
- CompanyAndromeda Surgical website, technology, timeline and team pages
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
