Adialante
A Mobile MRI delivered to clinics. No equipment to buy, no infrastructure needed.
Adialante
A Mobile MRI delivered to clinics. No equipment to buy, no infrastructure needed.
"Panacea has become a true extension of our team. Their ex-FDA team and their expertise is invaluable, their AI-powered approach allows us to move much faster without sacrificing quality, and fixed pricing took all the risk out of the engagement. I am so glad to have found a partner like them to lead such a critical function." — CEO, Adialante
"Panacea has become a true extension of our team. Their ex-FDA team and their expertise is invaluable, their AI-powered approach allows us to move much faster without sacrificing quality, and fixed pricing took all the risk out of the engagement. I am so glad to have found a partner like them to lead such a critical function." — CEO, Adialante
The Novelty
Two million people die every year from cancers that an early diagnosis could have caught. MRI has the power to intervene early enough to save lives. But traditional scanners cost millions, take months to install, and remain locked inside hospital walls, accessible only to patients who are already symptomatic.
Adialante is changing that.
Their breakthrough MRI architecture weighs 80% less, uses 60% less power, and runs near silent. Their MRIs are deployed in grid-independent box trucks, bringing the full imaging stack directly to clinics. Instead of clinics waiting months and spending millions, they can get patients scanned same-day.
Their vision: routine annual scanning that catches high-risk cancers early, for everyone.
Two million people die every year from cancers that an early diagnosis could have caught. MRI has the power to intervene early enough to save lives. But traditional scanners cost millions, take months to install, and remain locked inside hospital walls, accessible only to patients who are already symptomatic.
Adialante is changing that.
Their breakthrough MRI architecture weighs 80% less, uses 60% less power, and runs near silent. Their MRIs are deployed in grid-independent box trucks, bringing the full imaging stack directly to clinics. Instead of clinics waiting months and spending millions, they can get patients scanned same-day.
Their vision: routine annual scanning that catches high-risk cancers early, for everyone.
The Challenge
However, a novel imaging device with an entirely new architecture and delivery model means a demanding FDA pathway: regulatory strategy, pre-submission engagement, 510(k) authoring, and quality system buildout, all on a startup timeline where every month of delay is measured in lives not yet screened.
However, a novel imaging device with an entirely new architecture and delivery model means a demanding FDA pathway: regulatory strategy, pre-submission engagement, 510(k) authoring, and quality system buildout, all on a startup timeline where every month of delay is measured in lives not yet screened.
The Solution
Rather than a traditional consultancy billing by the hour with bloated engagements and timelines, Adialante partnered with Panacea. Panacea's AI-native approach, seasoned FDA regulatory experts paired with purpose-built AI workflows, compressed their regulatory timelines by months and at lower cost compared to other consultants who quoted them. Fixed, milestone-based pricing also gave Adialante risk-free, cost certainty from day one.
The result: a sharper regulatory strategy, the fastest, most efficient regulatory pathway, and a quality system built to scale, so Adialante can focus on what matters: getting scanners into the field and catching cancer early.
Rather than a traditional consultancy billing by the hour with bloated engagements and timelines, Adialante partnered with Panacea. Panacea's AI-native approach, seasoned FDA regulatory experts paired with purpose-built AI workflows, compressed their regulatory timelines by months and at lower cost compared to other consultants who quoted them. Fixed, milestone-based pricing also gave Adialante risk-free, cost certainty from day one.
The result: a sharper regulatory strategy, the fastest, most efficient regulatory pathway, and a quality system built to scale, so Adialante can focus on what matters: getting scanners into the field and catching cancer early.