Consumer health & wellness · AI dermatology
MDalgorithms
A dermatologist and his son built an app that grades a selfie and ships a customized acne kit. Nine years on, the company sells three direct to consumer brands, has one peer reviewed trial to its name, and has deliberately stayed out of the part of skin AI that regulators watch most closely.
The thing they decided not to look at
In May 2016 a health trade reporter sat with two Israeli dermatology entrepreneurs who had just put an acne app into the iTunes store. It took a selfie, graded the breakout on a ten point chart dermatologists use, and returned a skincare plan. Ten thousand people had downloaded it.
Buried in that write up is the decision that shaped the company. “By sticking to the area of acne, the founders believe they can have the biggest impact and avoid getting mired in the complexities and controversy of the melanoma detection side of teledermatology.”
Six years later the chief executive said it outright in an interview: “I believe that AI technology is not ready for automated analysis of skin cancer and melanoma.”
That is an unusual thing for a founder in this category to volunteer.
The category around it
Consumer skin algorithms have a documented record of trouble. In 2011 the Federal Trade Commission settled with the marketers of AcneApp and Acne Pwner, which claimed a phone screen could cure acne; the orders barred treatment claims without scientific evidence. In 2020 a systematic review in The BMJ examined nine studies of six algorithm based skin cancer apps and concluded that “Current algorithm based smartphone apps cannot be relied on to detect all cases of melanoma or other skin cancers.” It also found the European CE marking process inadequate for these products.
In 2024 a cross sectional study in JAMA Dermatology catalogued 41 AI dermatology apps. None had FDA approval; only five had a peer reviewed publication behind them. MDacne appears there, filed under acne treatment and monitoring rather than diagnosis, with the largest store rating counts in the sample. The authors concluded that these apps “in their current state, they may pose harm due to potential risks, lack of consistent validation, and misleading user communication.”
Against that backdrop, MDalgorithms sells creams and shampoos, not verdicts on moles.
A father, a son, and a light bulb
Yoram Harth graduated from the Sackler School of Medicine in Tel Aviv in 1982, trained in dermatology at Rambam in Haifa, and did a research fellowship at Columbia Presbyterian. He helped develop blue light phototherapy for acne vulgaris, and in 2007 co-founded EndyMed Medical, whose device won an Edison award in 2013.
Oded Harth grew up writing software, served in an Israeli military technology unit, and sold a small startup in high school. “He came to me with the idea and the problem,” he said of his father in 2016, when the company was still in Herzliya. He moved to Silicon Valley at 24 for Y Combinator. An early investor, Moxxie Ventures, wrote in 2022 that what it liked most was not the technology: “What we loved even more was the founding team: a father-son duo!”
From one app to three brands
MDacne launched a full product line in January 2018, backed by Y Combinator, Khosla Ventures and SV Angel. MDhair arrived in November 2021, pairing over the counter minoxidil with botanicals and supplements. Moxxie announced its seed investment in August 2022, and that November Deloitte placed the company on its Technology Fast 500 with reported revenue growth of 1178% from 2018 to 2021, top 25 in life sciences. By 2026 a third brand, Nuvane, was selling an anti-aging regimen, and Inc. listed MDalgorithms at No. 1,629 on its 5000.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA drug listings | Eight products under labeler MDalgorithms. Six are OTC monograph drugs under application M006: benzoyl peroxide, salicylic acid and sulfur creams and a cleanser, marketing start 2024. Two are minoxidil solutions under generic applications ANDA076239 and ANDA078176, marketing start Jun 2021. | Public record |
| FDA device clearance | No 510(k) and no PMA for MDalgorithms as of Sep 24, 2026. The image analysis is not a cleared device, and is not marketed as one. | Public record |
| Hair loss trial | J Drugs Dermatol 2025;24(3):233-238. A 24 week single center, single blind trial: 38 women with self reported thinning, 27 completed. Expert grading found improvement in growth, coverage and thickness (P<0.001). Shedding fell 37.3% at 12 weeks. No adverse events reported. | Public record |
| Who wrote that trial | The March 2025 release calls it “the first third-party clinical trial”. Two of the four authors in PubMed are O Harth and Y Harth, the CEO and the chief medical officer. | Differs from the record |
| Acne evidence | The company site says the kits were “validated through customer surveys. Over six months, 33 participants reported significant acne reduction”. The Y Combinator profile calls them “Clinically validated and tested by dermatologists”. No acne trial appears in PubMed. | Claim exceeds the record |
| Regulatory wording | The 2018 release cited “FDA-cleared, medical-grade ingredients”; the MDhair page promises “clinically proven and FDA-cleared topical hair growth ingredients”. Clearance is a device pathway. The record shows monograph and generic drugs, regulated but not cleared. | Wording differs |
| Training data | In 2022 the CEO described “the world’s largest database, with more than 5 million images of people with acne and hair loss”. The 2025 hair model is described as trained on 47,000 scalp images. Neither set has been audited. | Company-stated |
| Anti-aging brand | The corporate site describes an IRB approved 12 week Nuvane study, n=38, presented in Athens in May 2026. The Nuvane site reports four week results with n=41. | Company-stated |
| Independent audit | JAMA Dermatology, 2024: MDacne is one of 41 AI dermatology apps reviewed, listed under treatment and monitoring, with the highest rating counts in the sample. | Independent |
| Enforcement | No FDA recall record and no FTC action found for any of the three brands. | Public record |
Read plainly: the hair business is the one with published evidence, and that evidence is a small single center study whose author list includes both founders. The acne business, older and larger, rests on a survey of 33 customers. The corporate description says the technology “analyzes blemishes, lesions, and hair conditions with unmatched precision”, while the current MDacne reference page says its content “should not be considered a substitute for professional medical advice or care” and describes a flow that starts with a quiz. Both can be true at once. Which one a customer reads first is the part worth watching.
What to watch
- Whether an acne trial is ever published. There is one on hair, none on the product that made the name.
- Whether the Nuvane conference data reaches a journal, and whether the n=38 and n=41 figures resolve.
- Whether MDacne keeps the selfie model. Its own 2026 reference page describes a quiz.
- Any change in FDA posture toward software that grades disease severity.
- A first Form D. Nothing from this company has ever appeared in SEC full text search.
In their words
“I believe that AI technology is not ready for automated analysis of skin cancer and melanoma.”
Oded Harth, co-founder and CEO, Authority Magazine, 2022 · Interview
“We started one year ago with 100 acne patients. We worked with them to take photos and on image analysis,”
Yoram Harth, co-founder and CMO, MedCity News, 2016 · Independent
“80 percent of people with acne don’t get to a dermatologist because it’s expensive”
Yoram Harth, MedCity News, 2016 · Independent
“Using algorithms and computer vision we want to disrupt the way Acne is treated with our mobile health platform,”
Oded Harth, The Times of Israel, 2016 · Independent
“We would like MDacne to be the stepping stone and expert assistant for the 50 million people in the U.S. struggling with acne at any given moment,”
Oded Harth, Dermatology Times, 2016 · Independent
“This study highlights the potential of AI-driven personalization in hair care, offering a safe and effective comprehensive inside and outside non-medicated option supported by both subjective and objective clinical outcomes,”
Yoram Harth, MD, FAAD, to Dermatology Times, 2025 · Independent
“What we loved even more was the founding team: a father-son duo!”
Moxxie Ventures, seed investor memo, 2022 · Investor
Related companies
Sources
- Public recordopenFDA NDC directory, eight listings under labeler MDalgorithms
- Public recordDailyMed product labels for MDalgorithms
- Public recordAI-Based Personalization of Treatment Regimen for Hair Loss
- Public recordAlgorithm based smartphone apps to assess risk of skin cancer in adults
- Public recordFTC final settlement orders over acne cure app claims
- Public recordSEC EDGAR full text search, zero hits
- Public recordSkin & Digital, the 2022 startups
- IndependentCurrent State of Dermatology Mobile Applications With AI
- IndependentDermatology entrepreneurs develop app to analyze acne selfies
- IndependentPhone app seeks to bust acne using selfies and algorithms
- IndependentApp aims to supplement physician visits for acne
- IndependentAI Model Creates Treatment Regimens for Women with Hair Loss
- IndependentAI for hair loss? MDalgorithms unveils adaptogenic solution
- InterviewHealth Tech: Oded Harth Of MDalgorithms
- InvestorAnnouncing our Investment in MDalgorithms
- IndependentMDalgorithms is a 2026 Inc. 5000 honoree, No. 1,629
- IndependentYoram Harth, biography and inventions
- IndependentSkin cancer diagnosis apps are unreliable and poorly regulated
- CompanyMDacne Launches Mobile Acne Analysis and Customized Medications
- CompanyMDalgorithms Recognized by Deloitte Technology Fast 500
- CompanyClinical Trial Results for AI-Powered Hair Loss Treatment
- CompanyMDhair Wins 2025 BeautyMatter Award for Best Use of Technology
- CompanyCorporate site, MDacne and MDhair pages, Nuvane site
- CompanyMDalgorithms Inc. company and launch profiles
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
