Solutions
Implantables and therapy devices, connected with care
Neurostimulators, insulin pumps, hearing implants and cardiac devices deliver therapy continuously, usually through a companion app or an external controller. Extra Horizon provides the certified backend behind those apps: therapy data, patient and clinician access, managed updates for apps and external components, and algorithms in your own cloud cluster.
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Therapy that never stops
The highest risk class, connected to a phone
Active implantable and therapeutic devices are typically Class III. Connecting them brings a companion app, a clinician portal and a backend into the same high-risk product.
Class III scrutiny for everything connected
Everything connected to a high-risk device inherits its scrutiny. The backend behind the companion app needs the same documentation discipline as the device itself.
Devices that stay for years
Implants stay in patients for many years. The apps, controllers and cloud services around them must be supported, patched and kept compatible for just as long.
Access must be precise
Patients, carers, implanting surgeons and follow-up clinicians each need their own view of therapy data — and nobody else may see it.
Built on the Extra Horizon platform
Everything around the implant, already built
Connect your therapy device's companion app to a certified backend that already manages devices, updates, access and algorithms — so your team can stay focused on the therapy.
Device fleet management
Link every implant and external component to its patient, and track serial numbers, software versions, battery state and follow-up status.
Learn more →Over-the-air updates
Ship updates to companion apps, external processors and controllers in stages, with a record of which component runs which version.
Learn more →Identity & access management
Give patients, carers and clinicians scoped access to therapy data, with multi-factor authentication for everyone who can see it.
Learn more →Diagnostics in the cloud
Run your own analysis on therapy and usage data in your own cluster, triggered each time the companion app syncs.
Learn more →Medical backend-as-a-service
Model patients, devices, therapy settings and follow-up visits with your own schemas, on a dedicated backend hosted in the region you choose.
Learn more →Regulations & certifications
Build on a platform certified to ISO 13485, ISO 27001 and IEC 62304, and inherit its evidence into your own technical documentation.
Learn more →Built for high-risk devices
Evidence for the connected part of a Class III device
For active implantables, reviewers examine the app and the cloud around the device as carefully as the device itself. Build them on a platform that arrives with the evidence already in place.
MDR Class III and FDA PMA
High-risk devices need complete software lifecycle and cybersecurity documentation. A qualified supplier certified to IEC 62304 and ISO 13485 covers the backend part of that file.
Cybersecurity
FDA section 524B and IEC 81001-5-1 expect patchable systems, access control and vulnerability management for every connected component.
Post-market surveillance
Structured field data from companion apps and devices feeds your PMS reports and PSURs, instead of another round of manual exports.
Let's talk about your therapy device!
Get in touch, explain what you want to build, or have us help you build, and we'll get back to you ASAP! →