BETA
Developing dye-free optical imaging to help surgeons assess cancerous tissue during surgery, initially focused on breast lumpectomy margins.
BlackLight Surgical is a privately held medical device company in Los Angeles, California. Its LinkedIn profile lists a 2016 founding year. The technology originated in the Department of Neurosurgery at Cedars-Sinai, and the company is led by CEO and board member Frank Cheng.
Its biochemical imaging platform analyzes tissue autofluorescence using time-resolved laser-induced fluorescence spectroscopy and machine learning. The initial breast surgery application scans excised tissue to help surgeons assess specimen margins during a lumpectomy. Other oncology and tissue-assessment applications remain potential extensions.
BlackLight reports FDA Breakthrough Device Designation and preliminary clinical work at Cedars-Sinai. Marketing authorization and commercial availability were not established in this review. Engineering and technology suppliers describe development work with Triple Ring Technologies, Hamamatsu/NKT Photonics and SciChart.
BlackLight’s biochemical imaging platform remains in development. The company reports FDA Breakthrough Device designation; no matching published marketing decision was found. Designation is a development program, not permission to sell the device. [2][9][14]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [16][17]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
No commercially marketed product portfolio has been established in the reviewed material.
Development system combining laser excitation, time-resolved autofluorescence measurement and machine learning to characterize tissue without injected dyes or drugs. Designed for assessment of excised breast tissue during surgery. [1][2][7][4][5]
Investigational / in developmentDevelopment and clinical-study platform; commercial launch not established.
SciChart’s 2024 case study describes integration of its charting library for imaging-data visualization. This is supplier evidence rather than evidence of clinical efficacy or sales. [6]
NKT Photonics, now presented under Hamamatsu Photonics, described use of its aeroPULSE PS UV laser in BlackLight’s development platform. This documents a technology supplier relationship, not a distribution agreement. [5]
BlackLight reports FDA Breakthrough Device Designation for its breast surgery imaging technology. The reviewed materials do not establish the designation date or letter; this is not marketing authorization. [11]
The company describes prototype studies at Cedars-Sinai with 121 participants. Study methods, patient-versus-specimen analysis and peer-reviewed validation were not established; reduction in repeat surgery remains an intended benefit. [2]
Triple Ring Technologies describes delivering an integrated optical imaging platform and transferring quality-system documentation for clinical studies. A commercial launch date is not established. [4]
Accessed 10/20/2026