Medical devices & diagnostics · Spine imaging AI
Synapsica Healthcare
A Bengaluru company that tried to write the spine report for the radiologist. It won a US clearance in March 2023, for the smaller of its two spine products, and the public record has gone quiet since.
The post that went up on a Friday
On March 31, 2023, three days after the decision date on the letter, Meenakshi Singh wrote on LinkedIn about what it had cost to get there.
“It is easy to forget all the effort, frustrations and disappointments when you reach a milestone,” she wrote, thanking four colleagues by name and calling one of them the mother of Radiolens.
The company post she was sharing put it more simply: “The wait is over! SpindleX, the AI reporting tool for stress X-rays of the spine, is now #FDA 510(k) cleared.”
The wording matters. The cleared device is RadioLens v1.0, an image management and processing system, and SpindleX rides inside it as an optional module. Spindle, the MRI spine product Synapsica was better known for in India, is not in the clearance at all.
Four seconds an image
The problem is supply. India has fewer than 10,000 radiologists serving more than 30,000 imaging centres, a ratio Synapsica repeated in interviews and which NITI Aayog later carried on its Frontier Tech Hub. On an eight hour day, the founders said, that leaves three to four seconds per image.
“Errors and inconsistencies are uncomfortably common in radiology practice, with studies estimating an average of 30 per cent retrospective error rate among radiologic studies,” Singh told The Better India in 2022.
Spine was the wedge. Back and neck pain has ranked near the top of the global tables for years lived with disability since 1990, and the pathologies are mostly degenerative, so they recur in almost every scan. That is repetitive reading a machine can learn, and a different bet from the rare finding detectors that dominated early radiology AI.
Chief technology officer Kuldeep Singh Chauhan framed the stakes in the same article: “Misinterpretation by a radiologist can result in severe health complications that can be detrimental to the health of the patient and may even lead to death.”
An engineer, a doctor and a coder
Singh grew up in Mau, a small town in Uttar Pradesh, in a family of doctors. She took an engineering degree at Manipal, worked at Google, Misys, Manhattan Associates and Goldman Sachs, and did a management degree at IIM Ahmedabad. Dr Cherian, the COO, is an MBBS from AIIMS New Delhi. Chauhan is an IIT Kharagpur alumnus and, like Singh, a former Goldman Sachs vice president. Y Combinator lists a fourth founder, Gandharv Goyal, a director on both Indian registrations.
The founding date depends on the record. Y Combinator says 2018; press coverage and NITI Aayog say December 2019. India’s registry shows two entities: Synapsica Technologies Private Limited, incorporated July 18, 2017, and Synapsica Healthcare Private Limited, incorporated December 23, 2019 as a subsidiary of Synapsica Healthcare Inc.
Workflow first, device second
The order of the build matters. Radiolens, a cloud PACS and workflow layer, came first in 2019, with a clinical research partnership at AIIMS New Delhi the same year. Spindle for MRI spine and SpindleX for stress X-rays followed in 2020, alongside a distribution and research tie up with Spinal Kinetics in the United States. Crescent, for chest X-rays, came later.
Money and distribution arrived in 2021. A $4.2 million Series A led by IvyCap Ventures and Endiya Partners, with Y Combinator and angels, was announced on June 22. In December, GenWorks Health, the Wipro GE backed distributor, took Radiolens into what it called more than 300 tier 2 and tier 3 towns.
In May 2022 the diagnostic chain Aarthi Scans and Labs, which the announcement said runs more than 900 MRI scans a day, agreed to put Spindle behind its spine MRIs. The 510(k) was filed on July 21, 2022 and cleared on March 28, 2023.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K222174 | RadioLens v1.0, sponsor Synapsica Healthcare, Inc., Frisco, TX. Received Jul 21, 2022, decision Mar 28, 2023, Substantially Equivalent. Class II, product code QIH, 21 CFR 892.2050. Predicate: Spine CAMP, K221632. | Public record |
| What the clearance covers | DICOM display, processing, storage and transfer except mammography, plus an optional SpindleX module that analyses vertebral body displacement on cervical and lumbar digital stress X-rays, semi-automatically, to grade spinal ligament injury leading to subluxation under the AMA Guides 5th and 6th editions. Adults over 18 only, and not after surgery or trauma that distorts spinal anatomy. | Public record |
| Spindle for MRI spine | Not named in the clearance and not found in any FDA 510(k) record. An openFDA search on Sep 23, 2026 for applicant Synapsica returns exactly one device, K222174. | Not found |
| Training data | 13,452 cervical and 6,492 lumbar retrospective de-identified studies from over 200 US institutions, with points pre-marked by US board certified radiologists as ground truth. | Public record |
| Validation study | Multi-reader multi-centre retrospective study, 600 stress X-rays (300 cervical, 300 lumbar) from over 200 US institutions, independent of training data, three expert radiologists. Body part identification 100% sensitivity against a 95% target; position identification 96.8%, 92.0% and 90.5% against a 90% target. On measurements, model agreement with radiologists matched agreement among the radiologists themselves, ICCs mostly good to excellent. | Public record |
| Website versus record | Archived pages said of Spindle, “We have applied for 510(k) clearance from FDA,” and of Radiolens, “FDA 510(k) clearance in progress.” The clearance that followed covers RadioLens with the stress X-ray module only. | Differs from the record |
| Peer-reviewed evidence | A PubMed search on Sep 23, 2026 returns three records, all versions of one multi-society statement on AI in radiology. The only mention of the company is a competing interests line in which a Radiology Partners physician leader discloses consulting for it. No validation paper found. | Not found |
| Deployment scale | Claims escalate across company sources: 250 doctors across 500 hospitals and centres (2021), then 600 locations in 15 countries, 1 million cases, and 2,000 radiologists and centres (NITI Aayog, June 2025). No independent audit found. | Company-stated |
| Indian filings | Synapsica Healthcare Private Limited, CIN U74999DL2019PTC359165: paid-up capital Rs 1.15 crore, FY2021 revenue Rs 2.07 crore, last AGM Nov 30, 2021, last statements filed for the year ended Mar 31, 2021, no registered charges, DPIIT recognised. | Public record |
| Current status | Y Combinator lists the company as Inactive. The last archived capture of synapsica.com is Jan 13, 2026, and on Sep 23, 2026 the domain served a certificate for an unrelated hostname. No shutdown, sale or wind-up was announced. | Unresolved |
Read plainly: the one thing here a regulator checked is the stress X-ray module, and it checked out. Its measurements agree with radiologists about as well as radiologists agree with each other, across 600 cases from more than 200 institutions. Everything beyond that, including the MRI product that carried the India business, rests on the company’s own account.
What to watch
- Whether Spindle, the MRI spine product, ever appears in an FDA record. It has not by September 2026.
- Any peer-reviewed publication of the reader study behind K222174. The numbers are in the 510(k) summary and nowhere else.
- Whether synapsica.com returns. The domain presents a certificate for another host and the archive stops in January 2026.
- Where the founders are now. Meenakshi Singh’s LinkedIn profile, accessed September 23, 2026, lists her at Mintelligence Pte Ltd, with earlier posts naming her CTO and CMO of LAIQA Wellness. No Synapsica role is shown.
- Whether the Indian subsidiary files again. The most recent financial statements on the registry are for the year ended March 31, 2021.
In their words
“We are obsessed with radiologists’ experience on our platform, and direct our research and tech development to create the best possible environment for clinical diagnosis.”
Meenakshi Singh, co-founder and CEO, Series A announcement, June 2021 · Company release
“Errors and inconsistencies are uncomfortably common in radiology practice, with studies estimating an average of 30 per cent retrospective error rate among radiologic studies.”
Meenakshi Singh, to The Better India, 2022 · Interview
“Misinterpretation by a radiologist can result in severe health complications that can be detrimental to the health of the patient and may even lead to death.”
Kuldeep Singh Chauhan, co-founder and CTO, to The Better India, 2022 · Interview
“In the backdrop of shortage of radiologist workforce globally, the most basic impact of automation will be to increase efficiency and productivity of radiologists, reduce radiologists’ burnout, and hence make reliable diagnoses available to more patients.”
Meenakshi Singh, interview with The Financial Express, February 2022 · Interview
“When I saw the demo of Synapsica’s MRI spine solution, I couldn’t wait to deploy it in our MRI imaging workflow.”
Dr Arunkumar Govindarajan, director and radiologist, Aarthi Scans and Labs, May 2022 · Partner statement
“It is easy to forget all the effort, frustrations and disappointments when you reach a milestone.”
Meenakshi Singh, LinkedIn, March 31, 2023 · Founder post
Related companies
Sources
- Public recordFDA 510(k) letter, indications for use and summary, K222174
- Public recordPubMed record 38246898, competing interests naming Synapsica
- Public recordIndian registry summaries for both Synapsica entities
- Public recordSEC EDGAR company and full text search for Synapsica, no filings
- IndependentInnovation Helps Radiologists Read MRIs in Under a Minute
- InterviewAI can significantly improve radiology reporting: Meenakshi Singh
- IndependentFunding alert: Synapsica Healthcare raises $4.2M
- IndependentAI radiology company Synapsica partners with Aarthi Scans and Labs
- Independent#startupoftheday 113, Synapsica, with funding and product timeline
- IndependentReimagining Radiology: Faster, Smarter Diagnostics With AI
- CompanySynapsica product pages for Spindle, SpindleX and Radiolens
- CompanyMeenakshi Singh LinkedIn post celebrating the SpindleX 510(k) clearance
- CompanyCompany page and Y Combinator listing, status Inactive
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
