System Overview:
- FDA grants 510(k) clearance to Scale Eye, a new endoscopy system by Fujifilm.
- Components include an endoscope (model EC-760S-A/L) and support software (model EW10-VM01) within the Eluxedo Endoscopic Imaging System.
Key Features:
- On-screen linear or circular scale aids in measuring polyps, lesions, or other areas of interest.
- Utilizes laser positioning to measure distances from the object to the endoscope’s tip.
Clinical Validation:
- Positive results from UEG Week 2022 showcased the system’s 98.2% accuracy rate in measurements, compared to 89% accuracy with forceps.
- Significantly reduced measurement time of 2.8 seconds, as opposed to 8 seconds with forceps.
Clinical Impact:
- Dr. Seth Gross from NYU Langone Health highlights the importance of accurate size assessment in decision-making, particularly for polyp removal and patient follow-up intervals.
- Early data from NYU Langone Health shows promising results, positioning Scale Eye as a valuable tool in endoscopy.
Availability:
- System expected to be available for purchase later in 2024, following a limited market evaluation for user feedback and economic considerations.