Baxtra Surgical
Intraoperative imaging, robotic instrumentation and bioresorbable biomaterials — designed with surgeons, in a wet lab, not in a slide deck.
Our platforms
FDA 510(k) cleared · July 2026
Lumavue™
Real-time tissue perfusion imaging. A near-infrared fluorescence camera system with quantitative perfusion analytics, giving the surgeon a numerical readout of tissue blood supply rather than a subjective impression of brightness.
- Quantitative perfusion index displayed in under two seconds
- Integrates with standard laparoscopic and open towers
- Intended for assessment of tissue perfusion in general, colorectal and reconstructive surgery
Indications, contraindications and warnings are in the Instructions for Use. Rx only.
Design verification
SealWeave™
Bioresorbable staple-line sealant. A synthetic resorbable matrix applied along a staple or suture line to reinforce it during 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.
Prototype / preclinical
Axion OR™
Robotic soft-tissue instrument platform. A compact, cart-mounted system built around instrument dexterity and force feedback rather than console size, aimed at hospitals that cannot justify a full robotics suite.
- Seven-degree-of-freedom wristed instruments
- Haptic force feedback at the surgeon interface
- Designed to fit an existing OR footprint without renovation
Investigational device. Not available for sale.
How we design
Our Palm Beach Gardens facility is 24,000 square feet of 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. Contact surgical@baxtra.com.
Distribution
Lumavue is currently distributed directly in Florida, Georgia and Texas. We are evaluating additional US regions for 2027.
Training
Every Lumavue installation includes on-site training and access to our simulation lab for surgical teams.
Service & support
Technical support is available to customer sites at support@baxtra.com or +1 (561) 555-0155.
Device quality & safety
Reporting a device problem
Report device malfunctions, injuries or near-misses to devicesafety@baxtra.com or +1 (561) 555-0142, and to the FDA MedWatch program. Keep the device and packaging where possible.
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.