The FDA has granted 510(k) clearance for Surgalign Holdings Inc’s (NASDAQ: SRGA) HOLO Portal surgical guidance system for use within lumbar spine procedures.
- The Company says that the HOLO Portal system is the world’s first artificial intelligence (AI)-driven augmented reality (AR) guidance system for the spine and the first clinical application of Surgalign’s HOLO AI digital health platform.
- The HOLO Portal system combines machine learning-based image guidance technology with AR, automated spine segmentation (i.e., anatomy recognition), and automated surgical planning utilizing proprietary AI software.
- Related content: Benzinga’s Full FDA Calendar.
- The AI system autonomously processes intraoperative images to create a patient-specific plan presented to the surgeon using the AR display.
- Preliminary Q4 and FY21 Results: For Q4 FY21, Surgalign expects sales of $21.5 – $21.9 million.
- For FY21, the Company sees sales of $90.2 – $90.6 million, better than the previous guidance of $88 million – $92 million.