Medical devices & diagnostics · Breast imaging
iSono Health
A wearable, automated 3D breast ultrasound built to work outside the radiology suite. Cleared by the FDA in 2022, launched commercially in January 2026, and now running the study that will show how well it performs.
The two-minute scan
The patient lies on her back and puts on a pair of soft, expandable cups held in place by disposable straps. A nurse or medical assistant settles the breast into the cup, adds a coupling medium, and clips a compact scanner on top. One click in the software starts it.
A linear ultrasound transducer sweeps the whole breast on its own. About two minutes later a full 3D volume sits on a laptop screen, viewable in radial, coronal, sagittal and transverse planes.
No sonographer holds the probe. That is the whole idea.
When the FDA cleared the system in 2022, a Fierce Biotech reporter said it looked like “the high-tech inverse of Madonna’s infamous cone bra.” The comparison stuck because the design is unusual. Most breast ultrasound still depends on a skilled hand moving a probe, one small patch of tissue at a time.
The gap it is aimed at
Mammography is the backbone of breast cancer screening, and it has a known weak spot. Dense breast tissue lowers both the sensitivity and the specificity of a mammogram, and it raises cancer risk on its own, according to the US Preventive Services Task Force.
Since September 10, 2024, federal rules have required every mammography facility to tell each patient about her breast density and that other imaging tests may help find cancer. That notice has pushed a new question into exam rooms: what is the next test?
Ultrasound is the usual answer, but handheld breast ultrasound depends on the operator, and trained breast sonographers are scarce outside imaging centers. Automated systems already exist. GE’s Invenia ABUS and Delphinus’s SoftVue both reached the market through the FDA’s premarket approval pathway, the route that requires clinical evidence. iSono’s bet is a smaller, portable version that an OB/GYN or primary care office can run. An early investor described it as “orders of magnitude less expensive than current technologies.”
One tension sits under the whole category. In 2024 the Task Force concluded that the evidence is insufficient to judge the benefits and harms of supplemental screening with ultrasound or MRI for women with dense breasts. Better access is one argument. Better outcomes is a harder one, and it is the one clinical data has to win.
Two engineers and a personal reason
Maryam Ziaei and Shadi Saberi were engineers in Silicon Valley who had known each other for years. Ziaei earned her PhD in electrical engineering at Stanford and spent more than 15 years designing microscale sensors and devices, including stints at Sandia and Integrated Device Technology. Saberi earned hers at Carnegie Mellon and designed consumer electronics at Broadcom and Intel.
They started in 2015. “My co-founder and I both lost close friends to breast cancer that was not diagnosed in time,” Ziaei told an investor interviewer in 2020.
She had an example at home. Her father, a materials scientist, founded an orthopedic implant company in the 1990s. She remembers him leaving the house in the middle of the night to pack spinal implants for a child who had been in an accident. The lesson she took from it: “as an engineer you can have a positive impact on people’s lives and create meaningful technology.”
The two worked on the idea while still employed, got into Y Combinator, raised an angel round, and later took money from Tsingyuan Ventures, since renamed Foothill Ventures. National Science Foundation small business grants paid for early engineering: $225,000 in 2017, then a Phase II award that grew to $1.48 million.
The handoff
The FDA cleared ATUSA in April 2022. Eighteen months later the founders brought in an operator. On November 1, 2023, Neda Razavi became CEO and chair of the board, with prior roles at Illumina, Roche, Abbott, Medtronic, Natera, Allergan and Baxter. Ziaei moved to an advisory role.
“I’m immensely proud to have served as iSono Health’s CEO for the past seven years,” she said in the announcement. Saberi stayed to lead the ultrasound system architecture and is the principal investigator on the company’s current NIH grant.
From cleared to commercial
A clearance is not a business. In early 2023, at the Arab Health conference in Dubai, Abdul Latif Jameel Health signed on as exclusive distributor for an initial 31 countries across the Middle East, Africa, South Asia and Southeast Asia. The same week, iSono won the conference’s Innov8 pitch competition. Frost & Sullivan later gave it a 2023 US New Product Innovation Award.
The US commercial launch came in January 2026, timed to J.P. Morgan Healthcare week. iSono sells ATUSA as “Ultrasound-as-a-Service,” bundling hardware, cloud software and consumables into recurring fees so a clinic does not have to buy a capital system. The company says it has “multiple paying clinics” through a Pioneering Partner Program. It has not named them.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K213620 | Cleared Apr 22, 2022 as a B-mode breast ultrasound imaging system. Predicate: an Ivu Imaging automated breast system (K080555, 2008). Testing listed in the summary: electrical safety, acoustic output, bench performance, usability with simulated users and patients, and radiologist review of sample images for image quality. Label: “not intended to be used as a replacement for screening mammography.” | Public record |
| AI lesion detection | Described by the company as in development and “for investigational use only.” Not FDA cleared. | Company-stated |
| AUDIBLE study, as registered | Observational case-collection registry (NCT07505797). Started Dec 16, 2025. Up to 800 women already referred for biopsy after BI-RADS 4 or 5 findings. Primary outcome: type and number of imaging exams collected. Primary completion estimated Aug 2027. Sites listed: UC Davis and Cypress Innovative Breast Care Center. NCI is a collaborator. | Public record |
| AUDIBLE study, as marketed | The launch release calls it “a pivotal multicenter clinical trial” comparing ATUSA with mammography and MRI, at UC Davis, Veda Trials (Axia Women’s Health) and City of Hope. | Differs from registry |
| Peer-reviewed papers | None found in PubMed searches for the company or product as of Sep 21, 2026. | Not found |
| Federal grants | NSF SBIR Phase I $225,000 (2017) and Phase II $1,481,250 (2019 to 2024). NIH/NCI R44 $1,043,109 (FY2024) and $956,621 (FY2025). Total $3.71M, matching the company’s “$3.7 million” non-dilutive figure. | Public record |
| Paying customers | “Multiple paying clinics,” not named. | Company-stated |
| Global distribution | ALJ Health named exclusive distributor for 31 countries (2023). No later deployment reports found. | Partner-stated |
Read plainly: ATUSA is a cleared imaging device with a strong access story and grant-backed validation underway. The data that would show how it performs against mammography, MRI and handheld ultrasound in real patients has not been published yet. AUDIBLE is where that answer starts.
What to watch
- Results from AUDIBLE. Primary completion is estimated for August 2027.
- A second FDA submission. The 2022 release called the clearance “the first of several intended FDA submissions” and described case collection to validate its deep learning models.
- Named clinic customers and published pricing for the service model.
- The Series A the company opened in January 2026.
In their words
“My co-founder and I both lost close friends to breast cancer that was not diagnosed in time.”
Maryam Ziaei, co-founder and former CEO, 2020 investor interview · Interview
“We automate the image acquisition to take the operator dependence out of the equation for consistent accuracy.”
Maryam Ziaei, 2020 investor interview · Interview
“About half of women in the US have dense breast which means that a mammogram struggles to find early small lesions in dense breast.”
Maryam Ziaei, LSI USA ’23 interview · Interview
“We are putting the power of a world-class radiology suite into the hands of local clinicians.”
Neda Razavi, CEO, January 2026 launch release · Company release
“Wearable, operator-independent ultrasound technologies have the potential to dramatically improve access, speed, and accuracy, especially for women with dense breasts.”
John R. Scheel, MD, PhD, MPH, Vanderbilt University Medical Center, quoted in the January 2026 release · Company release
“In developed countries, ultrasound has been proven effective as an adjunct to mammography to improve breast cancer diagnosis in women with dense breasts.”
Mohammad Eghtedari, MD, PhD, breast radiologist, UC San Diego, quoted in the 2022 release · Company release
“I come from a country with excellent healthcare and preventive services, but I know this is not the global standard.”
Simona Kijonková, founder, JSK Investments, to Vestbee, 2025 · Investor
Related companies
Sources
- Public recordFDA 510(k) summary, K213620
- Public recordClinicalTrials.gov NCT07505797, AUDIBLE
- Public recordNIH RePORTER 1R44CA291498-01
- Public recordNIH RePORTER 5R44CA291498-02
- Public recordNSF SBIR Phase I award 1722432
- Public recordNSF SBIR Phase II award 1927052
- Public recordUSPSTF breast cancer screening recommendation
- Public recordFDA facility resource on MQSA rules effective Sep 10, 2024
- Public recordFDA PMA P110006 (GE Invenia ABUS) and P200040 (Delphinus SoftVue)
- InterviewFounder’s Lessons: Dr. Maryam Ziaei, CEO of iSono Health
- IndependentTsingyuan Ventures rebrands to Foothill Ventures
- IndependentWearable, AI-powered whole-breast ultrasound system cleared by the FDA
- IndependentiSono launches point-of-care breast ultrasound system
- IndependentiSono Health launches wearable 3D breast ultrasound platform, opens Series A
- IndependentiSono Health team wins the Arab Health Innov8 competition
- IndependentJSK Investments backs US startup iSono Health
- InterviewMaryam Ziaei, iSono Health, LSI USA ’23 partnering interview
- CompanyFDA clears iSono Health’s ATUSA
- CompanyiSono Health unveils ATUSA commercial launch and opens Series A
- CompanyiSono Health appoints Neda Razavi as CEO and chair
- PartnerAbdul Latif Jameel Health and iSono Health distribution agreement
- AwardFrost & Sullivan 2023 New Product Innovation Award
- CompanyiSono Health website and team page
- CompanyiSono Health about page, 2019 archive
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
