Medical devices & diagnostics · Digital pathology
Morphle Labs
A Bengaluru and Boston company selling whole slide scanners and, now, a robotic microtome into cancer diagnostics. The company says its scanners are in clinical use in United States laboratories. None holds an FDA clearance for primary diagnosis, and the company says so on its own website.
A box arrives in Phnom Penh
On 28 September 2020 a slide scanner left a warehouse in Bangalore. Five days later it stood in a laboratory in Phnom Penh, and nobody from the company that built it was in the room. Travel was frozen. PATH Labs had bought it after a doctor there watched a demonstration video and sent an email.
The company logged the afternoon minute by minute: delivered at 3.30, remote support at 4.30, running at 6.00, a remote quality check at 6.30, first tissue scan at 6.35. The lab had assembled it themselves.
“This scanner, in fact, Cambodia’s first, is a huge step in our efforts to offer global quality pathology to patients in Cambodia,” the customer wrote afterwards. The account is the company’s own. No independent report of the installation was found.
The step before the image
Radiology went digital decades ago. Anatomic pathology, the discipline that decides whether a biopsy is cancer, still runs on glass. A technologist trims a wax block on a microtome, floats a slice a few microns thick onto a slide, stains it, and a pathologist reads it.
The pinch point is people. Morphle and the outlets covering it cite surveys showing more than 60 percent of histopathology laboratories worldwide report unfilled positions. Tech Observer attributed that figure to surveys cited by the company, not to its own source.
Most digital pathology companies attack the reading end. Morphle went after both ends: a scanner to turn glass into pixels, then a robot to cut the glass in the first place.
Founders, and a disagreement about who they are
Rohit Hiwale is the constant. Y Combinator lists him as the sole active founder. Coverage of the 2025 round calls him an IIT Kharagpur alumnus and second time founder with stints at Walmart Labs and Rippling, alongside Ashish Manmode as chief technology officer and Sunnel Daniel as chief operating officer.
Who founded it is reported three ways. FounderTrace and eHealth name Hiwale and Anchit Navelkar. Tech Observer names Hiwale, Manmode and Daniel. Y Combinator names Hiwale alone. The Indian register is the only dated record: Rohit Ramesh Hiwale director since 8 January 2020, Ashish Hariram Manmode since 21 October 2021.
The early pitch was price. “The cost of the existing digital machines for pathology is so high that it has not been acquired by most of the healthcare institutions,” Hiwale told YourStory in 2021. Hardware still starts at $17,000.
Cheap scanners first, then the robot
The company dates itself to 2017 and sold as Morphle Digital Pathology. In 2019 it won $75,000 from HealthVenture at C-CAMP’s National Bio Entrepreneurship Competition. The Indian operating company was incorporated on 8 January 2020 as a subsidiary of the US parent.
By September 2021 Hiwale said the company had made about 100 deployments, 20 of them outside India. That October the Korean AI firm Deep Bio bundled its prostate biopsy software onto Morphle’s platform. The landing page now claims 250 or more laboratories across 20 or more countries; in November 2025 Hiwale said more than 30 countries.
Then came the RoboTome, which the company calls the world’s first high throughput robotic microtome. The product page describes the RTM 30 cutting 100 slides per hour per unit at 4 microns, one operator supervising five machines. The distributor Technopath lists it. The Series A is the money to take it to market.
The suit that followed the scanners into the United States
Selling hardware in America attracted a competitor. OptraSCAN sued for patent infringement in the Western District of Texas in June 2023 over two patents covering automated slide scanning. That case was dismissed on venue grounds. OptraSCAN refiled in Delaware, where Morphle lost its motions to dismiss in October 2024, then won: on 21 January 2026 the court entered final judgment in Morphle’s favour. OptraSCAN has appealed.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA clearance for primary diagnosis | None. FDA 510(k) and PMA searches for Morphle, MorphoLens and RoboTome return no matches as of Sep 23, 2026. Product code PSY, whole slide imaging system, 21 CFR 864.3700, Class II, holds 23 records from about 11 companies, led by Philips, Hamamatsu and Leica. | Public record |
| What Morphle does hold | FDA establishment registration 3033165977, Lewes, Delaware, type “Develop Specifications But Do Not Manufacture At This Facility.” One listed product, RoboTome, created Dec 9, 2024, code IDO, Microtome, Rotary, 21 CFR 864.3010, class 1. No 510(k) or PMA number. | Public record |
| The company’s own account | Morphle publishes an article saying it is pursuing FDA clearance for the Morpholens 400 and that its US installed base runs under CLIA validated workflows, with lab directors validating research use only scanners under CAP guidance. | Company-stated |
| Patent litigation | W.D. Tex. 1:23-cv-00733, filed Jun 28, 2023, dismissed without prejudice Apr 18, 2024 under Rule 12(b)(3). Refiled as D. Del. 1:24-cv-00649 over US patents 10,338,365 and 10,586,376. Final judgment for Morphle Jan 21, 2026; appeal docketed Feb 2026. | Public record |
| Patent count | Series A coverage says more than 80 patents filed. The company home page, accessed Sep 2026, says 25 or more. No granted patent assigned to Morphle was found. | Claims differ |
| Peer reviewed validation | No PubMed paper on a Morphle scanner or the RoboTome, and no registered clinical study, NIH award or NSF award naming the company. | Not found |
| CE marking and India CDSCO | No CE certificate or Indian CDSCO device licence located. Series A coverage says the money funds regulatory approvals, putting them ahead rather than behind. | Not found |
| Indian corporate filings | Morphle Labs Private Limited, CIN U29309KA2020PTC131387, incorporated Jan 8, 2020, ROC Bangalore, DPIIT recognised, subsidiary of Morphle Labs Inc. Revenue of Rs 14.25 crore for FY2024, up 29 percent. No charges registered. | Public record |
| Named users | The NIH National Cancer Institute, an Optimus 6X in a breast cancer metastasis lab; PATH Labs, Cambodia; a dermatopathologist at TIAGA Pathology, Colorado; Deep Bio as software partner; Technopath as RoboTome distributor. All company published. | Company-stated |
Read plainly: a hardware company with revenue, customers and a court win, and no clearance for the clinical claim that matters most in its largest market. That is common in digital pathology, and Morphle is unusually candid about it, publishing an explainer that names the cleared systems and places itself outside that list. What is missing is the other half. Laboratories validating a research use only scanner under CLIA rely on concordance data. Morphle has published none, and no independent study of its image quality has appeared.
What to watch
- A 510(k) submission for the Morpholens 400. The company says it is pursuing one; nothing has appeared yet.
- A published concordance study from a laboratory running Morphle scanners clinically.
- The Federal Circuit appeal in OptraSCAN v. Morphle Labs, docketed 26-1461 in February 2026.
- Whether the RoboTome stays a Class I listed microtome or takes on diagnostic claims.
- FY2025 revenue for the Indian subsidiary, the only audited number this company publishes.
In their words
“The cost of the existing digital machines for pathology is so high that it has not been acquired by most of the healthcare institutions.”
Rohit Hiwale, founder and CEO, to YourStory, 2021 · Independent
“Histology remains one of the few critical domains still untouched by true automation, and that is where we have chosen to start.”
Rohit Hiwale, Series A announcement, November 2025 · Company statement
“The funds are primarily going towards capacity building and enabling us to operate at ten times the current scale,”
Rohit Hiwale to the Economic Times, Nov 25, 2025 · Interview
“RoboTome automates a step in cancer diagnostics that has never been automated.”
Rohit Hiwale to the Economic Times, Nov 25, 2025 · Interview
“At Morphle, we are pursuing FDA clearance for our Morpholens 400, our high-throughput flagship designed to scan 100 slides per hour.”
Morphle Labs, regulatory explainer on its own website, 2026 · Company-stated
“This is an India-for-the-world story. Morphle Labs is not a single product company.”
Pratip Mazumdar, partner, Inflexor Ventures, to the Economic Times, Nov 25, 2025 · Investor
“I have worked on a number of Digital Pathology platforms, the MorphoLens scans are by far the best I have worked with from a resolution and quality perspective.”
Dr. Ingerlisa Mattoch, TIAGA Pathology, Colorado, testimonial on the company website · Company-published
“This scanner, in fact, Cambodia’s first, is a huge step in our efforts to offer global quality pathology to patients in Cambodia.”
Dr. Vitou, PATH Labs, Phnom Penh, in a company blog post, 2020 · Company-published
Related companies
Sources
- Public recordopenFDA registration and listing, Morphle Labs Inc, 3033165977
- Public recordopenFDA 510(k), PMA and product code PSY queries, and PubMed searches
- Public recordFDA allows marketing of first whole slide imaging system
- Public recordOptraSCAN, Inc. v. Morphle Labs Inc., 1:23-cv-00733, W.D. Texas
- Public recordOptrascan, Inc. v. Morphle Labs, Inc., 1:24-cv-00649, D. Delaware
- Public recordMorphle Labs Private Limited, CIN U29309KA2020PTC131387
- IndependentMorphle Labs raises $5 million to automate core of cancer diagnostics
- InterviewMorphle Labs raises $5 mn in Series A led by Inflexor Ventures
- IndependentDeeptech startup Morphle Labs raises $5M in Series A
- InterviewThis medtech startup aims to empower healthcare institutions
- IndependentOptraScan sues India-based Morphle Labs for patent infringement
- CompanyThe FDA landscape in digital pathology
- CompanyRobotome and scanner product pages, throughput, resolution and pricing
- CompanyNIH National Cancer Institute case study and PATH Labs Cambodia blog post
- PartnerDeep Bio partners with Morphle Labs for image analysis
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
