AI-powered development platform for complex, regulated products.
What Eureka does
Integrate Eureka into your existing tools to do regulatory-grade work while managing records in a traceable system that complies with 21 CFR Part 11.
Deploy the Eureka system in your own virtual private cloud and bring your own model provider.
What our users report
100×more data points surfaced and analyzed to inform biologics program priorities.
70%reduction in verification test design cycle for a Class III medical device.
4×more orthogonal analysis on screening datasets for a clinical candidate.
10×more factors analyzed for autonomous robot design.
90%reduction in time to source compliant parts for novel power infrastructure.
Museum of Regulatory Failures
Up to 100×the intended insulin dose could be delivered because of a decimal-point error.
The Omnipod 5 Android app could misread doses entered without a leading zero if the user confirmed the displayed amount. U.S. software correction initiated in 2023.
85,863devices were covered by an insulin-app recall for premature pump battery depletion.
A repeating crash-and-restart cycle in Tandem’s t:connect app could drain the connected pump’s battery and interrupt insulin delivery. U.S. correction, 2024.
876surgical-navigation devices required correction because software could omit digits from displayed measurements.
The error could lead surgeons to set an incorrect instrument depth during cranial procedures. Medtronic StealthStation S8, U.S., 2024.
20.4 millionCPAP masks required updated warnings about interference with medical implants.
Magnetic clips could disrupt certain implants and medical devices. ResMed’s existing labeling did not identify all affected device types. U.S. correction initiated in November 2023.
66,390heart pumps were covered by a correction addressing heart-wall perforation risks.
Abiomed revised the instructions and warnings for Impella left-sided blood pumps. This was a labeling correction, not product removal. U.S. action initiated in December 2023.
879dialysis systems required correction after chemical leaching exceeded allowable safety limits.
Compounds were leaching from silicone tubing in Outset Medical’s Tablo systems. The correction targeted affected tubing. U.S., 2024.
9heart pumps failed inspection but were accidentally released to customers.
Abiomed recalled the affected Impella CP pumps in 2024. All nine were recovered before patient use.
100%of the children’s bicycles tested failed at least one laboratory requirement.
All 26 authority-selected samples. European Commission CASP 2024, excluding labeling checks.
Approximately 67 millionairbags were recalled because they could explode when deployed.
Takata inflators could deteriorate after prolonged exposure to heat and humidity. NHTSA’s cumulative U.S. count refers to airbags, not vehicles.
Approximately 37.8 millionfire extinguishers were recalled because they could fail during a fire.
Kidde extinguishers could clog, require excessive force to discharge, or eject their nozzles. U.S. recall, November 2017.
248days of continuous power could cause a Boeing 787 to lose all AC electrical power.
A software-counter overflow discovered in laboratory testing could disable all four main generator control units simultaneously. The FAA required power-down procedures at intervals no longer than 120 days. U.S., 2015.
171Boeing 737-9 MAX aircraft were grounded after a door plug separated in flight.
The FAA’s emergency action covered aircraft operated by U.S. airlines or in U.S. territory. January 2024.
2redundant navigation systems failed from the same software error on Ariane 5’s first flight.
An unprotected conversion from a 64-bit number to a 16-bit integer disabled both systems. Full-flight simulations had substituted software models for the actual navigation units. ESA/CNES investigation, 1996.
4rail operators withdrew Hitachi train fleets after structural cracks were discovered.
Investigators identified fatigue loads exceeding the original design assumptions, despite compliance with applicable industry standards. Great Britain, May 2021; Office of Rail and Road report, 2022.
Up to 100×the intended insulin dose could be delivered because of a decimal-point error.
The Omnipod 5 Android app could misread doses entered without a leading zero if the user confirmed the displayed amount. U.S. software correction initiated in 2023.
85,863devices were covered by an insulin-app recall for premature pump battery depletion.
A repeating crash-and-restart cycle in Tandem’s t:connect app could drain the connected pump’s battery and interrupt insulin delivery. U.S. correction, 2024.
876surgical-navigation devices required correction because software could omit digits from displayed measurements.
The error could lead surgeons to set an incorrect instrument depth during cranial procedures. Medtronic StealthStation S8, U.S., 2024.
20.4 millionCPAP masks required updated warnings about interference with medical implants.
Magnetic clips could disrupt certain implants and medical devices. ResMed’s existing labeling did not identify all affected device types. U.S. correction initiated in November 2023.
66,390heart pumps were covered by a correction addressing heart-wall perforation risks.
Abiomed revised the instructions and warnings for Impella left-sided blood pumps. This was a labeling correction, not product removal. U.S. action initiated in December 2023.
879dialysis systems required correction after chemical leaching exceeded allowable safety limits.
Compounds were leaching from silicone tubing in Outset Medical’s Tablo systems. The correction targeted affected tubing. U.S., 2024.
9heart pumps failed inspection but were accidentally released to customers.
Abiomed recalled the affected Impella CP pumps in 2024. All nine were recovered before patient use.
100%of the children’s bicycles tested failed at least one laboratory requirement.
All 26 authority-selected samples. European Commission CASP 2024, excluding labeling checks.
Approximately 67 millionairbags were recalled because they could explode when deployed.
Takata inflators could deteriorate after prolonged exposure to heat and humidity. NHTSA’s cumulative U.S. count refers to airbags, not vehicles.
Approximately 37.8 millionfire extinguishers were recalled because they could fail during a fire.
Kidde extinguishers could clog, require excessive force to discharge, or eject their nozzles. U.S. recall, November 2017.
248days of continuous power could cause a Boeing 787 to lose all AC electrical power.
A software-counter overflow discovered in laboratory testing could disable all four main generator control units simultaneously. The FAA required power-down procedures at intervals no longer than 120 days. U.S., 2015.
171Boeing 737-9 MAX aircraft were grounded after a door plug separated in flight.
The FAA’s emergency action covered aircraft operated by U.S. airlines or in U.S. territory. January 2024.
2redundant navigation systems failed from the same software error on Ariane 5’s first flight.
An unprotected conversion from a 64-bit number to a 16-bit integer disabled both systems. Full-flight simulations had substituted software models for the actual navigation units. ESA/CNES investigation, 1996.
4rail operators withdrew Hitachi train fleets after structural cracks were discovered.
Investigators identified fatigue loads exceeding the original design assumptions, despite compliance with applicable industry standards. Great Britain, May 2021; Office of Rail and Road report, 2022.
31wheelsets showed outward wheel movement before a Washington Metro derailment.
The problems accumulated from 2017 through October 2021. The NTSB found that the operator had not conducted the trend analysis needed to evaluate whether its mitigations were effective. Findings published in 2024.
About 4.8 millionvehicles were recalled because cruise control might not disengage.
NHTSA advised owners of affected Fiat Chrysler vehicles to stop using cruise control until repairs were completed. U.S., May 2018.
362,758vehicles were recalled over driver-assistance behavior that could violate traffic rules.
Tesla’s FSD Beta could mishandle certain intersections, speed limits and lane changes, increasing collision risk without driver intervention. The remedy was a software update. U.S., February 2023.
€1.5 billionwas added to a reactor’s construction estimate following weld-repair requirements.
EDF revised the Flamanville EPR budget after France’s nuclear regulator required repairs to eight noncompliant containment-penetration welds. October 2019 estimate, expressed in 2015 euros and excluding interim interest.
2nuclear reactors were permanently retired after replacement steam generators developed premature wear.
San Onofre Units 2 and 3 closed in 2013. According to the operator’s account of NRC findings, flawed computer modeling had underestimated conditions that caused tube vibration, wear and leakage.
2reactor-safety reports were rejected as too incomplete for detailed technical review.
Oklo’s accident-analysis and licensing-methodology reports left unresolved gaps involving uncertainty, design margins and safety analysis. The NRC rejected the reports without prejudice, allowing future submissions. U.S., January 2022.
About 1.9 millionsmartphones were recalled, including replacement phones issued after an earlier recall.
The Samsung Galaxy Note7 recall expanded after additional incidents involving replacement devices. The batteries could overheat and catch fire. U.S., October 2016.
6model years of Chevrolet Bolt EVs were covered by a battery-fire recall.
GM identified two manufacturing defects that could coexist in one battery cell: a torn anode tab and a folded separator. The recall covered 2017–2022 Bolt EVs and 2022 Bolt EUVs.
About 34,460battery-expansion modules and cables were recalled over overheating connections.
Connections between Goal Zero Yeti Link modules and EC8 cables could melt, creating fire and burn hazards. U.S., June 2024.
About 5,740portable power stations were recalled because their batteries could overheat.
The HALO 1000 recall addressed fire and burn hazards associated with its lithium-ion batteries. U.S., August 2024.
Approximately 1,200 megawattsof solar generation were lost during a grid disturbance.
NERC attributed the largest share of the loss to inverters calculating grid frequency incorrectly and shutting off their output. The findings prompted an industry alert in June 2017.
About 1.4 millionelectrical panels were recalled over overheating and fire risks.
The affected Schneider Electric Square D breaker boxes were installed in homes and commercial premises. U.S., June 2022.
About 2,600solar inverters were recalled because component failures could eject their covers.
Failing capacitors could cause heat buildup and force the enclosure cover off, creating fire and impact hazards. Eltek solar inverters, U.S., February 2019.
About 6,500power stations were recalled because emergency-power mode created a shock hazard.
The Predator 2000-Watt units had reversed AC outlet wiring when operating in emergency-power-supply mode. Harbor Freight Tools, U.S., July 2025.
31wheelsets showed outward wheel movement before a Washington Metro derailment.
The problems accumulated from 2017 through October 2021. The NTSB found that the operator had not conducted the trend analysis needed to evaluate whether its mitigations were effective. Findings published in 2024.
About 4.8 millionvehicles were recalled because cruise control might not disengage.
NHTSA advised owners of affected Fiat Chrysler vehicles to stop using cruise control until repairs were completed. U.S., May 2018.
362,758vehicles were recalled over driver-assistance behavior that could violate traffic rules.
Tesla’s FSD Beta could mishandle certain intersections, speed limits and lane changes, increasing collision risk without driver intervention. The remedy was a software update. U.S., February 2023.
€1.5 billionwas added to a reactor’s construction estimate following weld-repair requirements.
EDF revised the Flamanville EPR budget after France’s nuclear regulator required repairs to eight noncompliant containment-penetration welds. October 2019 estimate, expressed in 2015 euros and excluding interim interest.
2nuclear reactors were permanently retired after replacement steam generators developed premature wear.
San Onofre Units 2 and 3 closed in 2013. According to the operator’s account of NRC findings, flawed computer modeling had underestimated conditions that caused tube vibration, wear and leakage.
2reactor-safety reports were rejected as too incomplete for detailed technical review.
Oklo’s accident-analysis and licensing-methodology reports left unresolved gaps involving uncertainty, design margins and safety analysis. The NRC rejected the reports without prejudice, allowing future submissions. U.S., January 2022.
About 1.9 millionsmartphones were recalled, including replacement phones issued after an earlier recall.
The Samsung Galaxy Note7 recall expanded after additional incidents involving replacement devices. The batteries could overheat and catch fire. U.S., October 2016.
6model years of Chevrolet Bolt EVs were covered by a battery-fire recall.
GM identified two manufacturing defects that could coexist in one battery cell: a torn anode tab and a folded separator. The recall covered 2017–2022 Bolt EVs and 2022 Bolt EUVs.
About 34,460battery-expansion modules and cables were recalled over overheating connections.
Connections between Goal Zero Yeti Link modules and EC8 cables could melt, creating fire and burn hazards. U.S., June 2024.
About 5,740portable power stations were recalled because their batteries could overheat.
The HALO 1000 recall addressed fire and burn hazards associated with its lithium-ion batteries. U.S., August 2024.
Approximately 1,200 megawattsof solar generation were lost during a grid disturbance.
NERC attributed the largest share of the loss to inverters calculating grid frequency incorrectly and shutting off their output. The findings prompted an industry alert in June 2017.
About 1.4 millionelectrical panels were recalled over overheating and fire risks.
The affected Schneider Electric Square D breaker boxes were installed in homes and commercial premises. U.S., June 2022.
About 2,600solar inverters were recalled because component failures could eject their covers.
Failing capacitors could cause heat buildup and force the enclosure cover off, creating fire and impact hazards. Eltek solar inverters, U.S., February 2019.
About 6,500power stations were recalled because emergency-power mode created a shock hazard.
The Predator 2000-Watt units had reversed AC outlet wiring when operating in emergency-power-supply mode. Harbor Freight Tools, U.S., July 2025.
Recall totals count affected units, not confirmed malfunctions. Selected testing samples are not market-wide failure rates.
Biologics · Medtech · Energy
“I have thrown a lot at Eureka including leveraging its ability to help build scientific rationale for a new therapeutic program, research and design screening and characterization tests, and even handing off to junior team members to run with. Everything it creates is traceable and when the evidence isn’t there, it tells you that too. That transparency is what makes it actually usable in a regulated environment. Finally, Eureka integrates the work you give it as ongoing knowledge to provide the individualized context and taste of the scientist, team and organization.”
“I have done this work for a long time. The real unlock here is not time saved, but the questions we would have never found the time to answer but can make a huge difference. I am able to explore angles I would not have.”
“The report Eureka generated is extremely thorough and immediately drove design decisions with leadership. We could not get this result from any other AI tool and we tried them all. The team can see how Eureka is built for the demands of industry power users. We are going to throw more projects at it now that we know what it can do.”
“Eureka was pretty quick to find me the part with the exact footprint and certification required. I was not able to find it after putting in hours through a ChatGPT, Gemini and Google search. Additionally, even vendors were not able to source for specs we needed. Eureka would have made life very easy if I had this beforehand.”
“These test procedures are very good. It would take us 4 weeks to develop a single one of them and we would not be able to do it with such deep rigor as we need to develop hundreds of these. Eureka will be a massive help as we head towards device trials in 2027.”
“I would absolutely utilize Eureka again in understanding the biology and mechanistic insights behind protein targets (or disease indications). The knowledge base generation and constraints to remove the hallucinatory possibilities that create significant problems within AI-Science research enables a level of trust that was lacking in the larger commercial LLMs. I’m now actively exploring the myriad of other functions that Eureka can provide, and determining their applicability within my workflows with clients, partners and internal projects.”
“Wow! This is the kind of answer about regulatory requirements I was looking for. This Eureka AI is very impressive.”
“Eureka is a tool all bench scientists, regardless of experience, can use to execute research ideas.”
Onboarding and data controls
Onramps from different stages of product development
Secure data vault for proprietary data
On-demand integrations with R&D systems
Private by default with signed NDA option
Custom data and privacy controls