FDA Clears Surgalign's HOLO Portal Surgical Guidance System For Spine Procedures

The FDA has granted 510(k) clearance for Surgalign Holdings Inc's 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.
• As of December 31, 2021, preliminary cash and cash equivalents are expected not to be below $51.0 million after taking into account the cash consideration paid for Inteneural Networks Inc.
• Price Action: SRGA shares are up 21.8% at $1.03 during the premarket session on the last check Tuesday.