Our Product
The Next-Gen in Motorized Biopsy
Precision-GI™ brings high-speed motorized tissue acquisition to endoscopic ultrasound-guided biopsy, for cleaner, intact core samples with fewer passes.
Precision-GI™ uses a high-speed rotational cutting mechanism with controlled axial advancement. It produces a circumferential clean cut that preserves tissue architecture, in contrast to the fragmented tissue obtained by axial jabs and tissue tearing with manual needle technique.
In practice, that means cleaner, intact core samples available downstream for pathology, molecular and NGS testing.
Precision-GI™ is indicated for use* with an ultrasound endoscope (EUS) for biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjunct to the gastrointestinal tract.
*This indication is consistent with the device’s FDA 510(k) clearance (K231422).
The Device
Precision-GI™ Components
Select a component to explore the device and zoom into each part.
Clinical Rationale
Redefining the Standard of Care in EUS Tissue Acquisition
Although EUS-FNB needles have improved EUS biopsy diagnostic capabilities, the shift towards histopathological analysis, molecular testing and genomic sequencing emphasizes the growing need for advanced technology designed to maximize tissue quality and procedural effectiveness.
Standard of Care
✕ User dependent manual tool
✕ 2–5 passes / 30–50 stabs
✕ Time consuming
✕ Imprecise
✕ ~20% redo cases reported
✕ Poor quality
✕ Non-diagnostic biopsy rates
Precision-GI™
✓ Motorized
✓ Single pass / 2–3 actuations
✓ Shorter procedure
✓ Precise control
✓ Eliminates redo cases
✓ Excellent quality
✓ Adequacy for advanced diagnostic methods of molecular profiling testing
~84%
pooled sensitivity of EUS-FNB for malignant pancreatic lesions*
13%
five-year relative survival rate in pancreatic cancer**
* EUS-FNB pooled sensitivity for malignant pancreatic lesions. ** Five-year relative survival rate, pancreatic cancer.