Some people hate dilution, but in the case of $MDAI, selling these shares brings in cash, which is needed to develop new uses for the platform and fund commercialization. While more shares will be out there, hopefully, excellent execution by Vince and the team will create a much bigger pie for everyone to enjoy, while we also fund a device that will improve burn care. What if you need it yourself someday, or your family?

In fact, you can virtue signal to everyone that you are funding a critical medical device that will help America's readiness for mass casualty events!

-ChatGPT

The pattern is mixed—but MDAI is the glaring negative outlier

Of the 19 De Novo classifications granted in 2026, I can identify only five recipients with a directly traded company or publicly traded parent; the other 14 appear to be private companies.

Prices below are approximate and use today’s intraday prices around 10:10 a.m. Central:

-From ChatGPT

Ok so I keep seeing people compare DeepView's overall accuracy to whatever benchmark and moving on. Wrong question. Ask a burn surgeon what actually keeps them up at night and it's not "will my model be right on average" — it's "am I going to miss dead tissue that needed surgery." That's the whole ballgame in burn care, and it's the number nobody's talking about.

Here's the FDA validation study (164 patients, adults and kids included). Head to head, DeepView vs. actual burn physicians making clinical judgment calls:

That sensitivity gap is not a rounding error. Physicians are being conservative — understandably, nobody wants to over-treat — but that conservatism means real misses. A false negative here isn't a paperwork problem, it's a patient going back for a second surgery, sitting in a hospital bed longer, healing worse. The FDA gave De Novo clearance specifically because DeepView beat physicians on sensitivity while staying non-inferior on specificity. That's the tradeoff regulators decided was worth making, and it's the whole clinical case in one table.

Ok but does a hospital actually care?

Hospitals don't buy cool tech. They buy tech that either fixes outcomes or fixes the bill. Spectral's own health-econ modeling claims DeepView could drive:

• ~41% fewer unnecessary patient transfers
• 3+ days faster to surgery for the patients who need it
• 30%+ shorter length of stay in some burn scenarios
• ~$58k saved per patient in unnecessary-surgery costs, in their modeled scenarios

Big caveat, and I want to be upfront about it: these are company-generated projections, not real-world outcomes data yet. Treat them as a hypothesis the commercial rollout still has to prove, not a promise. Even so — if the real-world number ends up being half of that, the case for using this thing to make earlier surgical calls still holds up.

The part that actually matters for the stock: what does commercialization look like

Nobody knows. So instead of pretending I have a price target, here's a napkin-math range using a rough $200k–300k in average annual revenue per installed system (capital + software + service + consumables bundled together), assuming margins in line with other software-attached medtech once it scales:

I want to be clear these are illustrative, not a forecast — pricing, reimbursement, adoption speed, and competition can all wreck this math. But sit with the bottom rows for a second. This is a company currently valued around $60M. Even the 500-system row isn't a moonshot for a cleared device with a health system this size — it's a company that actually starts landing accounts.

BARDA's Commitment May Be One of the Strongest Signals Investors Are Ignoring

One of the most overlooked aspects of the Spectral AI story is not simply that BARDA funded the company's research. BARDA continued funding the program through regulatory approval and into commercialization.

Since 2013, Spectral AI has received approximately $273 million from BARDA and roughly $282 million in total U.S. government funding. More importantly, BARDA's most recent Project BioShield contract is valued at up to $150 million and was designed not only to support clinical validation and FDA De Novo clearance, but also procurement, deployment, and expanded distribution of DeepView Systems.

Following FDA De Novo clearance, BARDA did not end its support. Instead, in March 2026 it exercised an option providing an additional $31.7 million in accelerated, non-dilutive funding to continue development and procurement activities related to the DeepView System.

That sequence is noteworthy.

Government agencies routinely fund early-stage research projects. It is considerably less common for an agency to support a technology through years of development, clinical validation, FDA De Novo clearance, and then commit additional funding intended to accelerate deployment and procurement after commercialization begins. While I have not verified that this is unprecedented across all BARDA programs, it represents an unusually deep and sustained government commitment.

For investors, this matters because BARDA's objective is not to generate investment returns. Its mission is to support technologies that strengthen national medical preparedness. The agency has now invested hundreds of millions of dollars over more than a decade into the DeepView platform and continues to commit additional capital after FDA clearance. That does not guarantee commercial success, but it is a significant vote of confidence in both the technology and its potential public-health value.

The thing I think is getting completely missed: this isn't a burn-wound company

Everyone's pricing MDAI like DeepView-for-burns is the whole story. I don't think it is. The actual asset here is the multispectral imaging platform, the ML models, and the annotated wound-image dataset they've built underneath it. Burns is the FDA-cleared beachhead. If that same platform extends into diabetic foot ulcers, pressure injuries, trauma, battlefield medicine — and there's real reason to think it can, since the underlying tech isn't burn-specific — then burn clearance isn't the finish line, it's proof of concept for something a lot bigger.

That's a speculative bet, not a fact, and I want to say that plainly. But it's why I think the market is pricing this like a single-indication device company rather than a platform company that just got its first product cleared.

Not financial advice—do your own diligence; this is just how I'm reading the data. In FACT, I KEEP BUYING MORE STOCK, AND NOW I HAVE OVER 100,000 THOUSAND SHARES SO I WOULD LOVE FOR THOSE OF YOU WHO DISAGREE TO SHOOT ME DOWN SO I DO NOT BUY MORE. I'VE ALREADY LOST MONEY ON $MDAI SINCE MY AVERAGE PRICE IS $1.85. Hopefully, I have a few new points I have made, with some obvious help from my buddy 'chat' whose last name is GPT.

Summary 

• Spectral AI’s DeepView AI® received De Novo clearance by the FDA for burn indication on May 26th, 2026
• UKCA (United Kingdom Conformity Assessed) authorization was received March 7th, 2024
• This new category of device reflects a novel and potentially transformative technology to improve the standard of care for burn treatment using predictive AI
• BARDA (Biomedical Advanced Research and Development Authority) support will continue with another $31.7 million in non-dilutive funding

Investment Thesis for Spectral AI 

BARDA has already spent about $250 million dollars helping Spectral AI create this new technology for burn treatment. In keeping with their mission to improve medical preparedness in the USA, and to get 30 DeepView AI® Systems into US burn centers, BARDA awarded another $31.7 million in funding, with Spectral AI committing $9.7 million. Assuming the systems continue to perform well, a further add on contract could come online for placing another 140 systems across the US to burn centers and emergency rooms.
Even with $250 million spent by BARDA on developing this technology over the last ten years plus, the market cap of this entire company is only about $57 million at the time of this writing based upon the current stock price. This is a serious mispricing.

Market Sentiment 

This underpricing reflects that units have yet to be commercially sold. However, 30 units being placed starting this year and continuing into the next will allow hospitals to familiarize themselves with the technology and will coincide with studies to prove the economic value of this new platform. The word platform is relevant because it can eventually, subject to FDA clearance, be used to evaluate and and predict the treatment course for diabetic foot ulcers (DFUs), pressure wounds, traumatic wounds, and even possibly wound care after surgery.

How It Works 

The system uses multispectral imaging to look deep into the wound and read the reflection of 8 bands of light of the affected tissue in the near infrared spectrum. It can identify dead tissue, perfused tissue, infected tissue, hemoglobin oxygenation, tissue hydration, and tissue that should eventually heal. Having created an extensive database of previous burn wounds and which tissues will heal in 21 days and which will not, the AI predicts whether the entire wound will heal on its own in 21 days, or whether it will ultimately require skin graft surgery.

Spectral-ai.com

DeepView® AI (www.spectral-ai.com)

Per The Burn Validation Study, the DeepView AI® System in conjunction with their proprietary AI algorithm outperformed board certified burn room physicians by a statistically significant margin. This means that upon deployment throughout the US, the UK, and eventually the entire world, getting the appropriate treatment could no longer depend upon the patient having to be at a burn center with an burn expert present, if a facility has the system in place from Spectral AI. This could prevent many costly and painful flights, unneeded surgeries, and time in hospitals.

Potential Future Applications 

The company originally started researching and applying this system to analysis and predictive treatment using AI for diabetic foot ulcers. While yearly burn treatments in the US amount to direct costs of about $4.1 billion annually per the US government database CDC WISQARS, diabetic foot ulcer treatment costs amount to $9 billion to $13 billion annually - National Library of Medicine. The company has indicated that it believes this device can be a platform for many other types of wound care, though each indication requires a separate FDA approval.

The Bear Case 

After placing the units in US and international burn centers, questions about commercialization are likely holding the market price of the stock down.

• What will be the pricing?
• Will hospitals or physicians buy or lease?
• Will there be recurring software revenue?
• How fast will adoption occur?
• Will competitors easily and cheaply get around the numerous patents and 10 years plus of accumulated clinical data?

There is also some dilution expected from previous financing from both Avenue Capital Group and Hudson Bay Capital Management. The company could raise cash through dilutive stock sales, as is typical after FDA clearance for many companies, though nothing has been announced.

Conclusion 

Now is an important time for Spectral AI. Clearing the FDA hurdle and getting the additional BARDA funding to get units out in the burn centers is encouraging. Their headstart on the competition is real. They could significantly improve burn wound care, improve patient lives with more accurate diagnosis and treatment, and save hospitals time and money as well. Eventually, they could expand to many other types of wound care applications utilizing predictive AI to improve patient outcomes worldwide.

Disclosure: I have a beneficial long position in the shares of MDAI either through stock ownership, options, or other derivatives.

I wrote this article myself, and it expresses my own opinions. This is not a recommendation to buy this stock, even if it looks like it - do you own research - I could be wrong and have been in the past.

I have been buying $MDAI shares at this low price. (The market capitalization of the company is less than 20% of the $280,000,000 BARDA has spent enabling the company to build this technology - and the company has 100% ownership of the intellectual property, AFAIK)

But Fidelity is only allowing me to buy 10,000 shares at a time!

Does anyone else have such a restriction?