Spectral AI, Inc.

Spectral AI’s DeepView™ System Showcased at the 2026 American College of Emergency Physicians (ACEP) Scientific Assembly 

Spectral AI showcased its FDA-cleared DeepView System for the burn indication at the ACEP Scientific Assembly in Chicago, the world's largest emergency medicine conference, drawing an estimated 7,000 attendees. CEO Vincent Capone said the event offered direct engagement with emergency department decision makers and framed emergency care as a priority market for the company's commercialization push. The DeepView System received FDA De Novo classification in May 2026 and UKCA authorization in February 2024; it assesses burn wound healing potential using multispectral imaging and AI trained on over 340 billion pixels of wound image data. No new clinical, regulatory, or financial results were disclosed in this release.

•14d ago

Spectral AI Submits New Technology Add-On Payment (NTAP) Application for DeepView™ System

Spectral AI has submitted a New Technology Add-On Payment (NTAP) application to CMS for its DeepView System, using the alternative pathway enabled by its FDA De Novo authorization and Breakthrough Device Designation. If approved, NTAP status would generally cover approximately 65% of the technology's estimated cost, begin in October 2027, and last about three years, with a CMS determination expected in August 2027. Management frames the application as a key step to reduce hospital adoption barriers and support the commercialization of DeepView, a multispectral imaging AI device for burn-wound healing assessment.

•21d ago

Spectral AI Announces First Site Initiation Visit for DeepView System™ Clinical Study Supporting Label Expansion Strategy to Burns of the Head, Hands, and Feet

Spectral AI completed the first Site Initiation Visit for a clinical study supporting label expansion of its FDA-cleared DeepView System to burns of the head, hands, and feet. The SIV was conducted at Pinderfields Hospital in Wakefield, UK under Principal Investigator Dr. Preetha Muthayya, enabling patient enrollment to begin at the first site. The prospective training and validation study will enroll adult and pediatric patients, image wounds within 72 hours of injury, and assess healing through 21 days, with completion expected in 2027 across multiple UK sites.

•26d ago

Spectral AI Announces Upcoming Presentation at ACS Clinical Congress 2026 Highlighting the Use of Artificial Intelligence and Multi-Spectral Imaging in the Assessment of Burn Wounds

Spectral AI announced a presentation at ACS Clinical Congress 2026 (September 26-29, Washington, DC) on AI training and validation of its multi-spectral imaging device for burn wound evaluation. The presentation will be led by Dr. James H. Holmes IV of Atrium Health Wake Forest Baptist, with contributions from company Chairman Dr. J. Michael DiMaio. Management framed the talk as part of commercialization of the FDA-cleared DeepView System, extending awareness beyond the burn specialty to the broader surgical community. DeepView received FDA De Novo classification in May 2026 and UKCA authorization in February 2024; the company's BARDA contract is held through subsidiary Spectral MD.

•1mo ago

Spectral AI Showcases DeepView® System for Burn Indication and KOL Research at Southern Regional Burn Conference

Spectral AI showcased its DeepView System for Burn Indication at the Southern Regional Burn Conference, held September 10-12, 2026 in Williamsburg, Virginia, where KOL presentations from UAB's Dr. James Hwang and UMCNO's Dr. Jeffrey Carter supported the use of AI and multispectral imaging in burn wound assessment. CEO Vincent Capone said the company remains focused on advancing adoption following the FDA's De Novo Classification of the DeepView System in May 2026; the device also holds UKCA authorization in the United Kingdom granted in February 2024. DeepView assesses whether areas within burn wounds are unlikely to heal within 21 days, with image acquisition in 0.2 seconds and AI processing in roughly 20 to 25 seconds, trained against a proprietary database of over 340 billion pixels of burn wound imagery. Additional KOL presentations are scheduled at the Midwest Region Burn Conference (October 22-23, Columbus, OH) and the Northeast Region Burn Conference (November 13-14, Boston, MA).

•1mo ago

Spectral AI Announces 2026 Second Quarter Financial Results

Spectral AI reported Q2 revenue of $3.5 million, a decrease from the prior year driven by the transition to cost-share provisions in its BARDA contract following FDA clearance. Despite the revenue dip, the company significantly narrowed its net loss to $(0.13) per share and maintained a strong cash position of $14.0 million, supplemented by a $6.5 million draw on its credit facility. Management reiterated full-year revenue guidance of approximately $18.5 million and confirmed that the DeepView System remains on track for first commercial sales in the U.S. by the end of 2026.

•2mo ago

Spectral AI Names Darcy Bajko Chief Commercial Officer to Lead Global Sales Launch of FDA-Cleared DeepView® System for Burn Indication

Spectral AI appointed Darcy Bajko as Chief Commercial Officer, effective July 31, 2026, to lead the global launch of its FDA-cleared DeepView System for burn indication. The company aims to pivot from product development to commercial execution, targeting its first commercial sales by the end of 2026. Ms. Bajko brings experience from MediView XR and established med-tech firms like Integra LifeSciences and Smith+Nephew to drive clinical adoption.

•3mo ago

DeepView® System Highlighted at the 2026 British Burn Association Annual Conference

Spectral AI reflected on its participation at the British Burn Association Annual Conference, where its DeepView System was featured and a related presentation won first prize. Multiple presentations, including award-winning work by Dr. Jeffrey Carter, highlighted the system's efficacy in burn wound assessment and provided real-world evidence validating its performance. The DeepView System received FDA De Novo classification in May 2026 and UKCA authorization in 2024, utilizing a database of over 340 billion pixels to assess healing potential within seconds.

•4mo ago

Spectral AI to Participate in 2026 British Burn Association Annual Conference

Spectral AI will display its DeepView System at the British Burn Association Annual Meeting in Nottingham, June 17-19, 2026. The company highlights that the system received FDA De Novo Classification in May 2026 and UKCA authorization in February 2024, with first commercial sales expected by year-end 2026. CEO Vincent Capone stated the FDA approval creates significant runway for long-term shareholder value and aims to elevate the technology's profile among burn care professionals.

•4mo ago

MDAI: 8-K · proxy statement

Spectral AI, Inc. (MDAI) announced the results of its 2026 Annual Meeting of Stockholders, where shareholders approved the election of five directors, ratified the appointment of Forvis Mazars LLP as independent auditor, and authorized the issuance of shares to Hudson Bay Master Fund Ltd. under a Securities Purchase Agreement dated October 24, 2025. The company highlighted a pivotal regulatory milestone: receiving FDA De Novo clearance for its DeepView System for burn indication, which allows it to commence commercial distribution in the United States. This clearance follows the receipt of $31.7 million in advanced funding from BARDA to accelerate feature development. Management outlined plans to generate first-ever commercial sales by year-end 2026, including a Phase II BARDA contract for up to 30 devices in US burn centers and trauma centers. The company also intends to initiate an outcome study involving approximately 286 patients across 12 clinical sites in Q4 2026 to demonstrate the clinical benefits of its AI-driven wound assessment technology.

SEC 8-K•4mo ago

Spectral AI Receives FDA De Novo Clearance for DeepView® System for Burn Indication

Spectral AI received FDA De Novo classification for its DeepView System, authorizing immediate commercial distribution in the United States for burn care diagnostics. The AI-driven device provides clinicians with a predictive assessment of burn wound healing potential within 25 seconds, aiming to redefine the standard of care by enabling earlier interventions. This milestone marks the company's transition from development to commercialization, supported by federal funding from BARDA and validated against a database of 340 billion pixels.

•5mo ago