Microsoft stopped manufacturing HoloLens devices in December 2024 while several medical AR products still publicly reference HoloLens 2. Sira Medical’s search for a lighter, long-supported optical see-through successor shows how regulated software can outlive its hardware and turn a device change into fresh validation and regulatory work.
Microsoft stopped manufacturing HoloLens devices in December 2024 while medical AR software built around HoloLens 2 remains on the market.
Sira Medical still offers an FDA-cleared preoperative-planning application for the headset. Medical software can remain clinically relevant for longer than the hardware chosen during development, leaving suppliers and hospitals to manage stock, replacements, support deadlines and the cost of moving a validated product.
Sira Medical co-founder Rick Beberman described the effect in written answers to The XR Beat.
“We’re happy to sell our HoloLens application, but health systems understandably don’t want to invest in a sunsetting product.”
Medical AR Has Outlived HoloLens Production
Microsoft’s current HoloLens 2 release notes say HoloLens devices haven’t been manufactured since December 2024. The November 2024 Windows Holographic update was the final feature release for HoloLens 2, with monthly security servicing continuing through December 2027.
Microsoft also lists 28 February 2028 as the minimum UK security-update period for units bought by 28 February 2025. Security servicing doesn’t solve the supply problem. Hospitals considering a deployment need enough headsets, replacements, accessories and technical support for the expected life of the clinical software.
Other medical AR products also remain publicly tied to HoloLens 2. MediView’s XR90 clearance announcement identifies the headset as part of its visualisation and navigation platform. HipInsight describes its FDA-cleared system as using HoloLens 2, while Medivis continues to reference HoloLens. Xironetic’s FDA-cleared IntraOpVSP is designed for specified, performance-tested hardware, although its public product pages don’t name the current headset.
The XR Beat contacted Medivis, MediView, Xironetic and Surgical Planning Associates, the company behind HipInsight, on 4 August. Medivis sent an automated acknowledgement, while Xironetic and Surgical Planning Associates had not supplied substantive answers by 21 August.
MediView responded after publication on 25 August. Karly Kocik, its senior digital marketing and events manager, said the original request had been caught by the company’s email filters:
MediView is aware of the HoloLens 2 end of production timeline and has an active roadmap for our platform’s hardware path forward, which is underway alongside our regulatory work.
XR90 remains commercially available and fully supported on HoloLens 2. The Hololens 2 headset remains supported by Microsoft, including critical updates, until the end of 2027, allowing MediView to transition the supported headsets without any pause in product availability.
MediView said a hardware transition would require new FDA submissions and validation through a deliberate, multi-month process. It is working with alternative headset manufacturers under confidentiality agreements and cannot yet identify them.
MediView’s response indicates that Sira is not alone in facing regulatory work when moving its medical software to another headset. MediView has yet to name its replacement hardware or confirm the regulatory submission route.
Sira Can’t Treat Another Headset as a Simple Upgrade
The FDA granted Sira’s Augmented Reality Application 510(k) clearance under K232339 on 1 February 2024. The public FDA summary describes software that processes CT and MRI data into three-dimensional models for preoperative planning by trained clinicians.
Sira’s product page identifies its HoloLens application as FDA-cleared. The cleared use covers planning before surgery and excludes intraoperative use. The public FDA summary refers to an AR head-mounted display without naming Microsoft or a HoloLens model.
Beberman said Sira would need another FDA submission for a different headset because display performance and the interaction between the software and device form part of the validated system:
“Operative planning software needs a new FDA submission for each headset it runs on, so we’re not willing to go through that process again for a device that could be discontinued in a year or two.”
Beberman’s answer describes Sira’s regulatory position. The FDA’s public record doesn’t establish a universal rule for other medical AR suppliers. Sira is discussing alternatives with several unnamed headset manufacturers, although it won’t repeat the work for a short-lived device.
The Next Headset Must Fit Clinical Work
Sira favours optical see-through hardware because clinicians can see patients and colleagues directly while manipulating three-dimensional anatomy. The company doesn’t favour fully immersive VR or camera pass-through for the same job, citing comfort and latency.
Beberman explained:
“We’re in discussions with several alternative headset manufacturers but won’t commit until the form factor moves to something spectacles-like that still allows hologram manipulation like HoloLens does, and we’re convinced the manufacturer is committed for the long haul.”
A smaller headset still needs suitable image quality, hand or gesture interaction and support long enough to carry a regulated product. Dr José Ferrer Costa previously told The XR Beat that MedTech XR has to work within a couple of interactions because clinical staff have little time for setup or troubleshooting.
Sira’s mobile application runs on iPhone, iPad and Android for patient education and resident training. Sira is considering whether to seek clearance for mobile preoperative planning, although phones and tablets remove the immersive presentation it values. Its cleared planning offer remains linked to the head-mounted application.
Who Could Replace HoloLens 2?
No current device meets Sira’s full list.
Magic Leap 2 offers optical see-through AR, hand tracking and enterprise controls, although direct sales ended in March and reseller deliveries stop in December 2026.
DigiLens is pitching ARGO as a HoloLens migration platform, with waveguide optics and support for 3D AR.
XREAL AURA comes closest to Sira’s preferred glasses-style form factor on paper, with a 70-degree optical see-through display, 6DoF and hand tracking, although it isn’t due until autumn 2026.
Sira hasn’t named any of these manufacturers, and none has been validated for its application. Hospitals will still need evidence on clinical fit, supply, replacements and long-term support before a supplier can justify fresh regulatory work.
Update, 26 August 2026: This article has been updated to include a post-publication statement from MediView. The company said the original enquiry was caught by its email filters.
