Baxtra Surgical
Intraoperative imaging, robotic instrumentation and bioresorbable biomaterials — designed with surgeons, in a wet lab, not in a slide deck.
The surgical division funds Baxtra’s medical countermeasure work. Lumavue™ imaging is being evaluated for use inside isolation units, where a quantitative perfusion readout could support tissue assessment in a controlled care environment.
Cleared for public release. This page is published at public revision 26 of 41 with nothing withheld. It is the only page on this site of which that is true. Surgical technology is not subject to the dual-use policy; the Disclosure Review Board reviews this page for accuracy only. Queries regarding withheld material: disclosure@baxtra.pages.dev.
Our platforms
Select a system to view its product photograph.
Investigational · prototype
Axion OR™ X4
Four-arm robotic system for soft-tissue surgery, dimensioned to fit an existing theatre rather than a purpose-built suite. Seven-degree-of-freedom wristed instruments with force feedback at the grips.
View product photograph
Investigational · engineering prototype
Axion SP™
Single-port configuration. Three double-jointed instruments and a steerable camera pass down one 25 mm cannula, then open into a working triangle inside the cavity.
View product photograph
FDA 510(k) cleared · July 2026
Lumavue™
Near-infrared perfusion imaging with a quantitative readout, so an anastomosis can be compared with a number rather than an impression of brightness.
View product photographPhase 1 clinical evaluation
SealWeave™
Bioresorbable staple-line sealant. A synthetic resorbable matrix applied along a staple or suture line to reinforce it through the critical early healing window, then fully resorbed.
- Resorption profile matched to the 21-day anastomotic healing curve
- Applied through existing laparoscopic ports
- Under evaluation for gastrointestinal and thoracic procedures
Investigational device. Limited by United States law to investigational use.
How we design
Our surgical engineering facility is an engineering, prototyping and wet simulation space. Practising surgeons use our prototypes on tissue models roughly every second week, and the resulting design changes are logged against the specification rather than argued about later.
- Human factors and usability engineering to IEC 62366 from first concept
- In-house rapid prototyping, so a design change can be in a surgeon's hand within days
- Design controls and risk management under an ISO 13485-aligned quality system
- Cybersecurity and software lifecycle controls for all connected products
Working with us
Clinical evaluation partners
We work with a small number of hospital partners on device evaluation studies, selected for procedure volume and willingness to give blunt feedback on a prototype.
Distribution
Lumavue is currently distributed directly in multiple US regions. We are evaluating further US regions for 2027.
Training
Every Lumavue installation includes on-site training and access to our simulation lab for surgical teams.
Service & support
Every customer site is assigned a named field engineer, with loaner units held regionally so a fault never cancels a list.
Device quality & safety
Reporting a device problem
Device malfunctions, injuries and near-misses should be reported through your hospital’s risk management process and to the FDA MedWatch program. Keep the device and its packaging where possible — the failure mode is usually in the hardware, not the account of it.
Field actions and recalls
Baxtra has issued no field safety notices or recalls to date. Any future notices will be published here and communicated directly to affected sites.
Quality system
We operate a single quality system across both divisions, aligned to ISO 13485 and 21 CFR Part 820, with internal audit and management review on a fixed annual cycle.
Sterility and single use
Single-use components are supplied sterile and must not be reprocessed. Reprocessing invalidates the performance and safety data supporting clearance.