(SRGA) – FDA Clears Surgalign’s HOLO Portal Surgical Guidance System For Spine Procedures

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.
  • 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{b02bdf04de3f9bc06c998e855c65941e7d8f5cd012e86469a83340818e6b6d52} at $1.03 during the premarket session on the last check Tuesday.

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