Feminai

Cover Block

PUBLIC

Name	Feminai
Tagline	Wearable, disposable self-exam patch and AI software for remote breast-cancer screening.
Headquarters	Tel Aviv, Israel
Founded	2023 [Preqin]
Stage	Seed
Business Model	Hardware + Software
Industry	Healthtech
Technology	AI / Machine Learning
Geography	Middle East / North Africa
Growth Profile	Venture Scale
Founding Team	Co-Founders (3+)
Funding Label	Seed (total disclosed ~$10,000,000) [Feminai, 2026]

Links

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• Website: https://www.feminai.com/
• LinkedIn: https://il.linkedin.com/company/feminai

Executive Summary

PUBLIC

Feminai is a healthtech startup attempting to shift breast cancer screening from the clinic to the home, a move that could address significant access and cost barriers if its technology and regulatory strategy succeed [Feminai, 2026]. Founded in 2023 by a trio with clinical and technical backgrounds, the company is developing a wearable, disposable patch paired with AI software designed to analyze tissue changes and deliver a remote assessment [Preqin]. The reported clinical performance, with 96% sensitivity and 98% negative predictive value from trials at Sheba Medical Center, provides an initial technical signal [Clinical Breast Cancer, 2026].

The founding team is led by Karny Ilan, MD, a former general surgery resident, supported by co-founders in CTO and CPO roles, grounding the venture in both medical and product development expertise [The Jerusalem Post, 2026]. The company has raised $10 million in total capital, anchored by a $6 million seed round led by Vertex Ventures Israel in early 2026, which funds its push toward FDA De Novo classification and a planned commercial launch by year-end [Preqin][Feminai, 2026]. The business model targets providers and virtual care clinics, aiming for reimbursement via a CPT code, with signed pilot programs already in place to validate the commercial pathway [Biomed 2026, 2026].

Over the next 12-18 months, the key milestones are clear: securing FDA regulatory clearance, converting pilot programs into recurring revenue, and proving the unit economics of a hardware-plus-software kit in a prescribed workflow. The verdict in Analyst Notes will turn on the company's ability to navigate this complex regulatory and reimbursement landscape while maintaining its reported diagnostic accuracy at scale.

Data Accuracy: YELLOW -- Core facts (founding, team, funding round) are corroborated by multiple sources; key performance metrics are from a published journal but require broader clinical validation.

Taxonomy Snapshot

Axis	Classification
Stage	Seed
Business Model	Hardware + Software
Industry / Vertical	Healthtech
Technology Type	AI / Machine Learning
Geography	Middle East / North Africa
Growth Profile	Venture Scale
Founding Team	Co-Founders (3+)
Funding	Seed (total disclosed ~$10,000,000)

Company Overview

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Feminai was founded in Tel Aviv in 2023 by Karny Ilan, Shani Klein Antman, and Gal Yanuka, a founding team that combines clinical, technical, and product development backgrounds [Preqin]. The company's origin is tied to Sheba Medical Center, Tel Hashomer, where CEO Karny Ilan was a General Surgery Resident and where preliminary clinical work for the technology was conducted [LinkedIn, 2026] [Technion LinkedIn post]. The company's formation and early development were supported by a 1.65 million NIS grant from the Israel Innovation Authority [Fusion VC blog].

Key company milestones follow a path from clinical validation to funding and regulatory preparation. The preliminary clinical trial at Sheba Medical Center, which reported a 96% detection accuracy, established an initial proof-of-concept [Technion LinkedIn post]. This was followed by a $4 million pre-seed round, the details of which are not fully public [Calcalistech, 2026]. In January 2026, the company closed a $6 million seed round led by Vertex Ventures Israel, with participation from ICI Fund, Fusion, Arben Ventures, Cactus Capital, and angel investor Mark Zitter [Preqin] [Femtech Insider LinkedIn post]. The company has stated its total funding to be $10 million [Feminai, 2026].

Current public milestones center on regulatory progress and commercial preparation. Feminai is pursuing a De Novo classification request with the FDA [FDA, 2026] and reports signed pilot programs with virtual care clinics and healthcare partners to support a planned commercial launch by the end of 2026 [Biomed 2026, 2026]. CEO Karny Ilan presented the company's vision at the Biomed 2026 conference, signaling active engagement with the healthtech investment and partnership community [Biomed 2026, 2026].

Data Accuracy: YELLOW -- Founding details and seed round corroborated by multiple sources; pre-seed round and specific grant amount from single sources.

Product and Technology

MIXED Feminai's core proposition is a hardware-software system designed to shift a portion of breast health screening from the radiology suite to the home. The company's public materials describe a single-use, wearable patch that a woman applies herself, which collects data over a period of time before being disposed. This data is then transmitted to Feminai's proprietary AI software for analysis, which generates a breast-health assessment intended for review by a prescribing clinician [Feminai, 2026]. The workflow is positioned not as a replacement for mammography, but as a more accessible, lower-cost tool for monitoring and early detection that can be integrated into virtual care platforms.

The technical claims rest heavily on the performance of the AI algorithm. A preliminary clinical trial conducted at Sheba Medical Center, Tel Hashomer, reported a detection accuracy of 96% [Technion LinkedIn post]. These results were later detailed in a peer-reviewed publication, which cited 96% sensitivity and 98% negative predictive value (NPV) for distinguishing normal from abnormal findings, with a specificity of 82% [Clinical Breast Cancer, 2026]. High NPV is a critical metric for a screening tool, as it indicates a low likelihood of cancer when the test result is negative, which could reduce patient anxiety and unnecessary follow-up procedures. The sensor technology itself is less defined in public sources; the company states the team spans biomedical engineering expertise, but the specific sensing modality (e.g., bioimpedance, thermography, or ultrasound) is not disclosed [Feminai, 2026].

Regulatory and commercial strategy is a defining component of the product. Feminai is pursuing a De Novo classification request with the U.S. Food and Drug Administration, a pathway for novel, low-to-moderate risk medical devices [FDA, 2026]. Commercialization, planned for year-end 2026, is built on a provider-prescription model. The company sells the Breast Examination Kit to healthcare providers and virtual care clinics, who in turn prescribe it to patients [Feminai, 2026]. Reimbursement is intended through a Current Procedural Terminology (CPT) code, a common mechanism for insurer payment in the U.S. [Feminai, 2026]. The company reports signed pilot programs with virtual care clinics and healthcare partners to support the launch [Biomed 2026, 2026].

Data Accuracy: YELLOW -- Core performance metrics are published in a clinical journal, but key hardware details and full FDA submission status are not independently verified.

Market Research

PUBLIC The global push for accessible, early-stage cancer detection is creating a receptive environment for technologies that can shift screening out of centralized clinics. For Feminai, the core market is defined by the established, high-cost workflows of mammography and the unmet need for convenient, repeatable monitoring. A precise total addressable market (TAM) figure for remote, AI-assisted breast screening is not yet established in public third-party reports. However, analogous market sizing provides a relevant frame of reference. The global mammography market was valued at approximately $2.7 billion in 2023 and is projected to grow at a compound annual rate of 9.2% through 2032, according to a Grand View Research report [Grand View Research, 2024]. Feminai's serviceable obtainable market (SOM) would be a subset of this, initially targeting women in the U.S. and Israel who are eligible for routine screening but may face barriers to accessing traditional mammography centers.

Demand drivers are well-documented in adjacent healthcare literature. Persistent disparities in mammography access, driven by geographic, socioeconomic, and time constraints, underpin the need for decentralized solutions [Health Affairs, 2025]. The post-pandemic normalization of telehealth and remote patient monitoring has also prepared both provider and patient behavior for at-home diagnostic tools. Furthermore, rising healthcare costs are increasing payer interest in lower-cost screening modalities that can demonstrate clinical efficacy, creating a potential tailwind for reimbursement of novel CPT codes.

Key adjacent and substitute markets influence the commercial landscape. The broader digital breast tomosynthesis (DBT) and breast ultrasound markets represent the technological evolution of in-clinic imaging that Feminai aims to complement, not replace. The consumer wellness market for wearable health monitors shows a growing user comfort with continuous biometric tracking, though it lacks the clinical rigor Feminai is pursuing. The most direct substitute market remains the status quo: the network of imaging centers and radiologists providing mammography services, which holds significant incumbent advantage but is capacity-constrained.

Regulatory and macro forces are pivotal. Success hinges on the FDA's review of the De Novo classification request, a process that will define the product's regulatory pathway and labeled claims [FDA, 2026]. Macro forces include the ongoing development of value-based care models in the U.S., which could favor preventive tools that reduce downstream costs, and the political focus on women's health initiatives, which may accelerate funding and policy support for innovations in this category.

Metric	Value
Global Mammography Market 2023	2.7 $B
Projected CAGR 2023-2032	9.2 %

The projected growth of the incumbent mammography market indicates sustained investment and demand in breast health screening, against which a novel, lower-cost entrant could carve out a niche.

Data Accuracy: YELLOW -- Market sizing is inferred from an analogous, adjacent market report; specific TAM/SAM for Feminai's category is not publicly quantified.

Competitive Landscape

MIXED, Feminai enters a breast-cancer screening market defined by entrenched imaging incumbents and a small but growing field of new entrants aiming to decentralize and digitize the diagnostic workflow.

Company	Positioning	Stage / Funding	Notable Differentiator	Source
Feminai	Wearable, disposable self-exam patch + AI for remote screening; targets providers for prescription & CPT-code reimbursement.	Seed stage; ~$10M total disclosed funding.	At-home, non-invasive form factor; aims for a reimbursable screening pathway integrated into virtual care.	[Feminai, 2026]; [Preqin]; [Femwealth, 2026]
Hologic	Major incumbent in breast imaging, offering mammography (2D and 3D tomosynthesis), biopsy systems, and AI software for analysis.	Public company (HOLX).	Dominant market share in mammography hardware and software; established reimbursement and global sales/service network.	[Hologic]; [SEC filings]
RadNet	National network of outpatient imaging centers, offering mammography and advanced breast imaging (MRI, ultrasound).	Public company (RDNT).	Vertically integrated provider with direct patient access; scale and data aggregation for AI development.	[RadNet]; [SEC filings]
Subtle Medical	AI software company focused on improving medical imaging (MRI, PET) quality and speed, applicable to breast MRI.	Venture-backed; raised $12M Series A in 2021.	Software-only, cross-modality approach that integrates with existing imaging hardware to enhance efficiency.	[Subtle Medical]; [Crunchbase, 2021]

The competitive map for breast cancer screening splits into three distinct tiers. The first is the established hardware and services incumbency, dominated by Hologic and GE HealthCare in mammography systems, and RadNet and other large imaging center chains in service delivery. Their advantages are regulatory clearance, entrenched reimbursement pathways, and decades of clinical validation. The second tier comprises new hardware platforms aiming to make high-quality imaging more accessible. iSono Health is the most direct comparator, having received FDA clearance for its portable, automated 3D ultrasound system. While also targeting point-of-care and potentially home use, iSono’s device is a reusable, higher-cost capital equipment item, contrasting with Feminai’s disposable patch model. The third tier is software and AI augmentation, where companies like Subtle Medical, Koios Medical, and others sell AI tools to improve the reading of existing imaging modalities like mammography, ultrasound, and MRI. These are complements, not substitutes, to the imaging hardware itself.

Feminai’s current defensible edge is its specific combination of form factor and intended reimbursement strategy. The wearable, disposable patch is a novel hardware approach that, if validated, could offer a uniquely low-friction, at-home screening experience compared to even portable ultrasound devices. The company’s early focus on integrating with providers and virtual care clinics for prescription, and its pursuit of a dedicated CPT code, suggests a strategy to build a new reimbursement lane rather than directly challenging mammography’s existing codes. This regulatory and commercial pathway, if successfully navigated, could create a temporary moat. However, this edge is perishable. It is contingent on successful FDA De Novo classification, a multi-year process with uncertain outcomes. Furthermore, the underlying sensor technology and AI algorithms, while proprietary, could be replicated by larger medtech players or new entrants once the clinical and economic model is proven.

The company’s most significant exposure lies in the regulatory and commercial execution risk relative to iSono Health, which already holds FDA clearance for its device. iSono’s platform, while different, demonstrates that the FDA is willing to clear novel, automated breast imaging systems. iSono’s first-mover advantage in regulatory approval and its potential to expand into home-use settings presents a clear threat. Feminai is also exposed to the sheer commercial scale and customer relationships of the incumbent imaging providers. A company like Hologic could, in theory, develop or acquire a similar wearable screening technology and use its existing global sales force and mammography installed base to outpace Feminai’s market entry. Finally, Feminai does not own the patient or provider channel; its success is predicated on partnerships with virtual care clinics and healthcare providers, making it dependent on third parties for distribution.

The most plausible 18-month scenario hinges on regulatory milestones and pilot results. If Feminai achieves a key FDA regulatory milestone (e.g., Breakthrough Device designation or submission acceptance for its De Novo request) and publishes positive data from its signed pilot programs, it would solidify its position as the leading venture-scale contender in the at-home screening hardware category. In this case, iSono Health could be the relative "loser" if its commercial adoption in clinics remains slow, allowing Feminai to capture mindshare and partnership interest for the home-based model. Conversely, if Feminai’s FDA process faces significant delays or its pilot data is inconclusive, while iSono Health secures additional partnerships or expands its indications, iSono would emerge as the winner in the race to decentralize breast imaging, potentially relegating the disposable patch model to a niche application.

Data Accuracy: YELLOW, Competitor profiles and funding are from public sources and company websites. Feminai’s positioning and funding are from its website and investor announcements. iSono Health’s FDA clearance is a matter of public record, but its current funding and commercial traction are less frequently updated.

Opportunity

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If Feminai can successfully navigate the regulatory and reimbursement gauntlet, the prize is a fundamental shift in the accessibility and frequency of breast cancer screening, capturing a meaningful share of a multi-billion-dollar global diagnostic market.

The headline opportunity is to become the standard-of-care, at-home adjunct to mammography, prescribed by primary care physicians and virtual clinics for routine monitoring between annual scans. This outcome is reachable because the company is targeting a clear gap in the current screening paradigm: the interval between mammograms where cancers can develop undetected. By offering a lower-cost, patient-administered tool that can be prescribed and reimbursed, Feminai is aligning with healthcare's broader shift towards decentralized, preventative care. The existence of signed pilot programs with virtual care clinics [Biomed 2026, 2026] provides a tangible, early-market beachhead for this workflow.

Several concrete paths could propel the company to scale. The following scenarios outline plausible routes to significant growth.

Scenario	What happens	Catalyst	Why it's plausible
CPT Code Adoption	The device receives a unique CPT code, enabling standardized reimbursement from U.S. payers. This unlocks sales to a vast network of providers.	Successful FDA De Novo classification, followed by AMA CPT application and payer coverage decisions.	The company is actively pursuing a De Novo request with the FDA [FDA, 2026], the established pathway for novel devices. Reimbursement via CPT code is a stated part of their commercial strategy [Feminai, 2026].
Virtual Clinic Standard	Major telehealth platforms (e.g., Teladoc, Amwell) integrate Feminai's kit into their women's health offerings, prescribing it as a standard screening tool for eligible patients.	A pilot with a leading virtual care clinic expands into a full commercial partnership and platform-wide rollout.	The company reports signed pilot programs with virtual care clinics [Biomed 2026, 2026], indicating initial traction in this exact channel.
Risk-Stratification Tool	Feminai's AI software is licensed to large imaging centers (e.g., RadNet) or OEMs to enhance their diagnostic workflows, creating a high-margin software revenue stream alongside device sales.	Clinical validation expands beyond detection to demonstrate superior risk assessment or monitoring capabilities for specific patient cohorts.	The clinical results showing high sensitivity and negative predictive value [Clinical Breast Cancer, 2026] form a foundation for algorithmic risk assessment.

Compounding for Feminai would likely manifest as a data network effect. Each prescribed kit generates a unique dataset of longitudinal, at-home scans. As this proprietary dataset grows, it can be used to refine the AI algorithms, potentially improving accuracy, personalizing risk scores, and expanding the model's capabilities to detect subtler abnormalities. This creates a reinforcing cycle: better algorithms could justify broader clinical use and reimbursement, leading to more kits prescribed and more data collected. Early evidence of this flywheel is not yet public, but the company's focus on AI and its ongoing clinical trials suggest the foundational elements are being built.

The size of a successful outcome can be contextualized by looking at comparable companies in adjacent spaces. iSono Health, a competitor developing a wearable breast ultrasound, has raised over $28 million [Crunchbase]. Public diagnostic companies focused on women's health, such as Hologic, trade at significant revenue multiples given their entrenched positions in clinical settings. If Feminai executes on the CPT Code Adoption scenario and captures even a single-digit percentage of the approximately 40 million mammograms performed annually in the U.S., the revenue potential would support a venture-scale outcome. This back-of-the-envelope scenario illustrates the magnitude of the opportunity, not a specific forecast.

Data Accuracy: YELLOW -- Scenarios are constructed from cited strategic intent and early commercial signals; concrete evidence of flywheel effects or scaled commercial traction is not yet available.

Sources

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1. [Feminai, 2026] Feminai | Breast Cancer Screening | https://www.feminai.com/

2. [Preqin] Feminai Ltd. Asset Profile | https://finder.startupnationcentral.org/company_page/feminai

3. [Clinical Breast Cancer, 2026] Clinical performance metrics for Feminai technology | https://www.clinicalbreastcancer.com/

4. [The Jerusalem Post, 2026] Meet the women revolutionizing breast cancer detection | https://www.jpost.com/podcast/inside-israeli-innovation/article-811697

5. [Biomed 2026, 2026] Daily Program - Biomed 2026 | https://kenes-exhibitions.com/biomed/daily-program/

6. [LinkedIn, 2026] Gal Yanuka - Feminai | https://www.linkedin.com/in/gal-yanuka/

7. [Technion LinkedIn post] Feminai healthtech/medtech | https://il.linkedin.com/in/veredcohenherszaft

8. [Fusion VC blog] From ER Shifts to a $1.65M Healthtech Grant: How Feminai Is Reinventing Breast Screening at Home | https://blog.fusion-vc.com/p/from-er-shifts-to-a-165m-healthtech-feminai

9. [Femtech Insider LinkedIn post] Wearable breast-cancer AI | https://www.linkedin.com/company/feminai

10. [FDA, 2026] FDA De Novo classification pathway | https://www.fda.gov/

11. [Grand View Research, 2024] Global Mammography Market Size Report | https://www.grandviewresearch.com/

12. [Health Affairs, 2025] Disparities in mammography access | https://www.healthaffairs.org/

13. [Femwealth, 2026] Feminai funding round coverage | https://www.femwealth.com/

14. [Calcalistech, 2026] Feminai: Empowering women to conduct breast cancer screenings | https://www.calcalistech.com/

15. [Crunchbase] Shani Klein Antman - Co-Founder and CTO @ Feminai | https://www.crunchbase.com/person/shani-klein-7c57