Startup Deep Dive : Remidio — the eye camera that screened 16 million people before it had full FDA clearance

A retinal camera small enough to clip onto a smartphone has been used to screen more than 16 million people across 55 countries, according to the company that builds it. Yet Remidio, the Bengaluru medtech behind that device, spent six years selling it into American clinics before the US Food and Drug Administration formally cleared it, in December 2025, as a Class II medical device.

That gap between global scale and slow regulatory recognition is the thread running through Remidio’s story. It is not a unicorn, it has not filed for an IPO, and it does not publish full financial statements. What it has built, across sixteen years and a still-modest funding history, is a case study in how a hardware-plus-AI company can reach millions of patients in low-resource settings long before it becomes profitable, or even fully licensed in its most lucrative market.

Quick facts

What they do

Remidio makes hardware and software for eye screening that is built to work outside a hospital eye department. Its best-known product, sold under names including FOP-NM and InstaFOP, is a handheld device that turns a smartphone into a fundus camera, capable of photographing the retina without dilating the patient’s pupil first. Paired with it is Medios AI, an on-device algorithm that reads those images for diabetic retinopathy, glaucoma and age-related macular degeneration without needing an internet connection. The buyers are not, in the main, individual patients. They are primary-care clinics, opticians, rural and mission health programmes, emergency departments, government screening drives and, increasingly, large US healthcare provider networks looking for a cheaper way to screen diabetic patients for eye disease before it causes blindness.

The origin

The company was incorporated in Bengaluru in November 2009. As the founder later told the International Agency for the Prevention of Blindness’s supplier programme, the specific idea traces to a conversation, around September 2010, with Dr Anand Vinekar, a paediatric ophthalmologist at Narayana Nethralaya who ran a tele-screening programme for premature babies at risk of blindness. Vinekar’s problem was mechanical as much as medical: the tabletop fundus cameras used to photograph a newborn’s retina were expensive, bulky and mostly imported, which meant they could only ever reach a fraction of the babies who needed screening across India. Sivaraman, trained at MIT, set out to solve the equipment problem rather than the diagnostic one first: build a retinal camera cheap and portable enough to travel to the patient, instead of the other way round. The company’s own account puts that first device at roughly one-fifth the cost of the tabletop systems it aimed to replace.

The struggle years

Remidio’s capitalisation history, tracked by the deal-data provider Tracxn, shows a company that grew slowly by startup standards. For its first several years on the register it raised only small, undisclosed seed and angel amounts, dated by Tracxn to May 2015, November 2015, January 2016, January 2017 and August 2017. It was not until May 2018, close to nine years after incorporation, that a named institutional lead, Montane Ventures, appears on the company’s Series A. For a hardware company, that is a long runway to fund on small cheques: every camera design, optical component and manufacturing run in those years had to be paid for without the kind of large venture round that consumer software startups of the same era were raising.

A second, quieter struggle sits in the company’s regulatory record. Remidio has been placing its FOP-NM camera with US healthcare providers since 2019, reaching more than 3,500 high-volume providers and, by the second quarter of 2024, its 1,000th US placement, according to BioSpace’s account of the milestone. For most of that period, the device was marketed in the US as an FDA 510(k)-exempt Class I product, a lighter regulatory bar than a full clearance. It took until 12 December 2025, six years after the first US placements, for Remidio to secure an actual 510(k) clearance for the FOP NM-10 as a Class II ophthalmic camera, according to the FDA’s own premarket notification database. A company can sell for years in America’s largest medtech market and still be working, slowly, toward the paperwork that unlocks its next stage of growth.

The turning point

Put those two facts next to each other and the turning point becomes visible. On one side of December 2025: a device already installed with more than a thousand US providers, screening patients since 2019, but resting on an exemption rather than a clearance. On the other side: an FDA decision, filed under submission K252120, that reclassifies the FOP NM-10 as a cleared Class II device rather than an exempt one. That single filing does not change what the camera does. It changes who Remidio can now sell to and how. A 510(k) clearance is generally what large hospital systems, insurance-linked procurement processes and bigger channel partners ask to see before they will commit at scale, in a way an exemption does not satisfy. For a company that had already proven demand the hard way, one placement at a time, the clearance is less an origin-story pivot than a lock finally turning after the door had been pushed on for six years.

The money behind it

Remidio’s funding has been raised in small, spaced-out increments rather than the large, headline Series rounds typical of Indian consumer startups. According to Tracxn’s funding record, the company has closed roughly ten rounds since 2015; CBInsights separately tallies at least $18.1 million in disclosed funding, while Tracxn’s cumulative figure, which includes smaller undisclosed tranches, runs to about $25 million. Neither source discloses a current valuation; Tracxn records that a valuation was set as of 4 March 2023 but does not publish the figure.

• Montane Ventures — led the Series A in May 2018, the company’s first named institutional round, roughly nine years after incorporation.
• Pureland Group — first invested in the Series B of December 2019, then returned to lead a larger June 2021 round alongside 14 other co-investors, broadening the syndicate considerably.
• Sun Pharmaceutical Industries — joined the Series B closed in February 2023, bringing a strategic pharmaceutical-industry investor onto the capitalisation table rather than a pure financial one.

Remidio was also one of five finalists, from more than 170 applicants, in the MedTech Innovator Asia Pacific 2020 competition, a programme backed by Johnson & Johnson Medical Devices, Siemens Healthineers, Olympus and other medtech corporates, competing for a prize pool of more than $250,000 at the November 2020 grand final.

How it makes money

Remidio sells hardware and recurring services rather than a single one-off product.

• Device sales — the FOP-NM/InstaFOP handheld camera and related autorefractors and slit lamps are sold or placed with clinics, hospital systems, opticians and screening programmes.
• AI software — Medios AI, the offline diabetic retinopathy, glaucoma and AMD screening algorithm launched from 2019 onward, is licensed alongside the hardware rather than given away with it.
• Teleophthalmology platform — a cloud layer connects images captured in the field to remote graders and specialists, useful for programmes that have cameras in rural centres but few ophthalmologists on site.
• Corporate and strategic partnerships — in March 2025 Remidio made a strategic investment in UK-based Occuity to co-develop non-contact myopia and glaucoma screening tools, extending its own device pipeline through a partner rather than in-house R&D alone, per ThePrint’s coverage of the deal.

The part people tend to get wrong is assuming a device this cheap must be a low-margin commodity play. The company’s own positioning is the opposite: the camera is priced to win the placement, and the AI software and teleophthalmology subscription layered on top are what is meant to carry the margin over the device’s working life. Whether that model has yet turned a profit is a separate question, and the disclosed numbers below suggest it has not.

The numbers

Remidio is privately held and does not publish full audited results. What is publicly available, filtered through the company-data provider Tofler, is a set of headline ratios for the year to March 2025 rather than a clean multi-year revenue and profit series. Where CBInsights’ industry estimate of $5.6 million in 2025 revenue is converted to rupees at $1 = Rs 96.0, it lands inside Tofler’s own Rs 50-75 crore estimated range for the same period, which is the closest thing to independent corroboration available for this figure.

A fuller three- or four-year revenue and profit history, of the kind audited filings would normally allow, sits behind Tofler’s paid subscription tier and was not accessible this session; it has been left out rather than estimated.

Where the money comes from

Remidio does not publish a revenue split by geography or product line, but its own disclosed footprint points to a business built on three legs rather than one home market.

• India, the founding market — screening programmes cited by the company run across states including Himachal Pradesh, West Bengal and Kerala, largely tied to public health and premature-baby retinopathy screening of the kind that inspired the original device.
• The United States, the scale market — more than 3,500 high-volume healthcare providers have used the FOP-NM for diabetic retinopathy screening since 2019, with the 1,000th US camera placement reached in the second quarter of 2024, according to BioSpace; the company runs a US office in Glen Allen, Virginia.
• A wider international footprint — the company cites deployments in Poland, Armenia, Mexico’s Yucatan peninsula, parts of Africa and the UK, plus a Singapore office serving the Asia-Pacific region, alongside HSA approval in Singapore secured in 2022.

The surprise is less where the patients are than how fast the count has moved: BioSpace’s 2024 account put cumulative screening at more than 15 million patients across 40-plus countries, while the company’s own website, current as of this research, claims more than 16 million people screened across 55 countries. Read together, that is growth of roughly a million patients and fifteen more countries inside about two years, on a company with 200-plus employees and three offices worldwide.

The risks

• A loss-making core business. Tofler’s estimate puts Remidio’s net profit margin at -5.62% for the year to March 2025, meaning the company is still spending more than it earns even as its revenue grows, on a business model that depends on continued external funding to reach profitability.
• Concentration in price-sensitive, programme-driven demand. A large share of Remidio’s disclosed deployments sit inside government and public-health screening programmes and NGO-run initiatives rather than open retail sale, which ties volume to tender cycles, budgets and programme renewals that the company does not control.
• A crowded and consolidating device category. Analysts such as CBInsights track Remidio directly against rival portable fundus-camera makers like Finland’s Optomed, and the underlying technology, a smartphone-based non-mydriatic camera, is not exclusive to Remidio; newer entrants and cheaper adapters raise the risk of the device itself being commoditised even as the AI layer on top tries to hold the margin.

The takeaway

The lesson in Remidio’s sixteen-year build is not about a dramatic near-death or a single pivot. It is about the cost, in time rather than capital, of selling into public health and regulated healthcare markets at once. A consumer app can win a market before regulators notice it exists. A medical device cannot: Remidio proved its camera worked, at a fraction of the usual cost, in tele-screening programmes in India years before Series A money arrived, and it kept selling that same camera in the United States for six years under an exemption before the FDA’s own clearance caught up with the business it had already built. Patience with the paperwork, not just the product, turned out to be the moat.

Frequently asked questions

What does Remidio actually make?

A handheld, smartphone-based fundus camera (sold as FOP-NM or InstaFOP) that photographs the retina without dilating the eye, paired with Medios AI, offline software that screens those images for diabetic retinopathy, glaucoma and age-related macular degeneration.

Who founded Remidio and when?

Remidio Innovative Solutions was incorporated in Bengaluru on 19 November 2009 by Dr Anand Sivaraman, who remains its Founder-CEO; the specific product idea is traced by the company to a 2010 conversation with paediatric ophthalmologist Dr Anand Vinekar about the shortage of affordable retinal cameras for screening premature babies.

How much funding has Remidio raised, and is it profitable?

Disclosed funding runs from about $18.1 million (CBInsights) to roughly $25 million cumulative (Tracxn) across around ten rounds since 2015, with backers including Montane Ventures, Pureland Group and Sun Pharmaceutical Industries; the company was still loss-making, with an estimated net profit margin of -5.62%, for the year to March 2025.

Is Remidio’s device FDA-approved?

The FOP NM-10 received US FDA 510(k) clearance as a Class II ophthalmic camera on 12 December 2025, according to the FDA’s premarket notification database, after several years of being marketed and placed with US providers under a lighter, exemption-based classification.

How many people has Remidio’s technology screened?

The company’s own figures, the most recent available as of this research, put cumulative screenings at more than 16 million people across 55 countries; an earlier, independently reported figure from 2024 put the count at more than 15 million people across 40-plus countries.

Sources

Figures are as of September 2026. Currency converted at $1 ≈ Rs 96.0 as of 18 September 2026 (Trading Economics).

• Tofler, company financial profile for Remidio Innovative Solutions Private Limited, accessed September 2026
• US FDA, 510(k) Premarket Notification database, submission K252120 (Remidio Innovative Solutions Private Limited), decision dated 12 December 2025
• Tracxn, “Remidio – Funding Rounds & List of Investors,” accessed September 2026
• CBInsights, Remidio company profile and financials pages, accessed September 2026
• IAPB Valued Supplier Scheme, “From Vision to Innovation: How Remidio is Redefining Eye Care with AI,” 2026
• BioSpace, “Health-tech innovator Remidio achieves unprecedented scale in the US with its revolutionary retinal solutions,” 2026
• Glance / Eyes On Eyecare, “Remidio’s portable fundus camera offers point-of-care imaging,” May 2026
• Remidio.com, “About Us” company page, accessed September 2026
• ThePrint, “India’s Remidio invests in UK’s Occuity to enhance non-invasive global disease screening,” March 2025
• MedTech Innovator, “MedTech Innovator Announces Finalists for US$250K+ Annual Asia Pacific Competition,” 2020

Found an error? Write to us and we’ll correct it in the open, dated, on the piece.