- No public price. The vendor says Kosmos Plus costs less than $20k.
- Attested
- Type II
- —
- 2016
- US
Radiology
EchoNous
by EchoNous Inc. · founded 2016 · US
Kosmos handheld ultrasound with AI bladder volume, ejection fraction, Doppler gate and FAST view guidance.
On this page
78/100
Editorial rating 5.0 / 5
- Regulatory & Compliance28/28
FDA cleared (4 K-numbers on record)
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength26/26
5 peer-reviewed papers
- Vendor & Market9/18
Founded 2016 (10 years)
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (4 K-numbers on record)
- HIPAA / SOC2 / BAA10/10
HIPAA + (SOC2 or BAA) attested
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers18/18
5 peer-reviewed papers
- RCT / meta-analysis / systematic review8/8
1 RCT/Meta-Analysis/Systematic Review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market6/6
Founded 2016 (10 years)
- Pricing transparency3/5
Pricing on request, no public amounts
Kosmos handheld ultrasound with AI bladder volume, ejection fraction, Doppler gate and FAST view guidance.
No public price. The vendor says Kosmos Plus costs less than $20k. HIPAA + SOC 2 Type II attested.
Evidence record
510(k)K242321 (opens in new tab)April 25, 2025
Kosmos
510(k)K233826 (opens in new tab)August 29, 2024
Kosmos
510(k)K212100 (opens in new tab)August 6, 2021
Kosmos
510(k)K193518 (opens in new tab)March 26, 2020
KOSMOS
5 studies on PubMed: 2 observational, 2 other, 1 RCT, published 2024 to 2026. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, EchoNous record, https://medaiverdict.com/tools/echonous, version November 2, 2026
Bottom line
EchoNous Inc. of Redmond, Washington, makes Kosmos, a handheld ultrasound that the vendor says helps novices scan and simplifies workflows for experts. FDA's records show four Kosmos clearances, from March 2020 to April 2025, all listed simply as Kosmos. The vendor's AI tools cover bladder volume, ejection fraction, Doppler gate placement and FAST views. It fits a service that wants guided scanning and automated measurements on a handheld. The price comes through a quote.
What does EchoNous say the Kosmos AI does?
The vendor lists five AI features. Kosmos Bladder AI gives real-time guidance and volume. Kosmos Ejection Fraction returns automated EF, stroke volume, cardiac output and heart rate, with manual override. Auto Doppler places pulsed-wave and tissue Doppler gates at the LVOT, mitral, pulmonic and tricuspid valves. AI FAST identifies and labels views and locates fluid areas, and Auto Preset switches between lung, abdominal and cardiac presets. Partner software comes from Us2.ai and 19 Labs, and some features are marked "not available in all markets".
For data, the vendor lists DICOM export and USB-C export in formats such as JPEG, and its FAQ says Kosmos supports a Modality Worklist once a DICOM profile is created. An SDK and API integration page exists, and no PACS or EHR vendor is named. The home page says the device is "HIPAA and SOC2 compliant for data protection and privacy" and lists SOC2 Type II and Cyber Essentials.
Which Kosmos clearances cover the AI?
FDA's records under EchoNous, Inc. include K181574, the Uscan bladder scanner, dated July 10, 2018, which is a different product. The four Kosmos clearances run from K193518, dated March 26, 2020, to K242321, dated April 25, 2025, all under product code IYN. Wikipedia says the 2021 clearance covered the Lexsa linear probe and later ones added AI tools. FDA's names read only "Kosmos," so which clearance covers Bladder AI, Auto EF, Auto Doppler or AI FAST is not itemized.
What does it cost?
EchoNous publishes no list price as of November 2026. Its FAQ says pricing depends on the configuration and the buyer's location and points to a quote request. The vendor calls Kosmos Plus the "best price performance system on the market for less than $20k" and mentions a five year warranty.
Where does EchoNous come from?
The About page confirms a 2016 founding in Redmond, and the home page says Kosmos is manufactured in the US. Wikipedia, whose figures the vendor's pages do not confirm, names Kevin Goodwin and Niko Pagoulatos as founders and reports $35M from KKR in 2017, $60M from Kennedy Lewis Investment Management in 2021, a $57M Series D in 2022 and a further $7M in 2023. The site names no customers and carries physician testimonials.
Who has tested Kosmos?
PubMed returns 12 results for Kosmos and EchoNous. PANES-HF (PMID 38866831) tested point-of-care AI-supported echocardiography by novices for heart failure screening. Other studies had oncology staff evaluate cardiac function with AI assistance during chemotherapy, followed Army medic trauma sonography with AI assistance, and validated a handheld device for aortic stenosis. Several papers put Kosmos among four to six handheld devices in expert comparisons.
The verdict
Kosmos suits a service that wants novice-friendly guidance and automated cardiac and bladder measurements on a handheld, and, per the vendor's FAQ, it supports a Modality Worklist once a DICOM profile is created. The vendor's own price claim for Kosmos Plus is "less than $20k."
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. The vendor says Kosmos Plus costs less than $20k. |
Source: vendor pricing page. Last checked November 2, 2026.
What deploys cleanly
Carries FDA 510(k), HIPAA, SOC 2 Type II per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
EchoNous (EchoNous Inc.) was founded in 2016 in US, putting it 10 years into market.
What the literature says
5 peer-reviewed studies indexed on PubMed evaluate EchoNous in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Army Medic Performance in Trauma Sonography: The Impact of Artificial Intelligence Assistance in Focused Assessments With Sonography in Trauma-A Prospective Randomized Controlled Trial. (opens in new tab)
- Hartline CPTAD, Hartvickson MAJS, Perdue CPTMJ, et al.· Mil Med· 2025
- Noncompressible truncal hemorrhage is a leading cause of preventable death in military prehospital settings, particularly in combat environments where advanced imaging is unavailable. The Focused Assessment with Sonography in Trauma (FAST) exam is critical for diagnosing intra-abdominal bleeding. However, Army medics typically lack formal ultrasound training. This study examines whether artificial intelligence (AI) assistance can enhance medics' proficiency in performing FAST exams, thereby improving the speed and accuracy of trauma triage in austere conditions. This is a prospective, randomi…
- Point-of-care AI-enhanced novice echocardiography for screening heart failure (PANES-HF). (opens in new tab)
- Huang W, Koh T, Tromp J, et al.· Sci Rep· 2024
- The increasing prevalence of heart failure (HF) in ageing populations drives demand for echocardiography (echo). There is a worldwide shortage of trained sonographers and long waiting times for expert echo. We hypothesised that artificial intelligence (AI)-enhanced point-of-care echo can enable HF screening by novices. The primary endpoint was the accuracy of AI-enhanced novice pathway in detecting reduced LV ejection fraction (LVEF) < 50%. Symptomatic patients with suspected HF (N = 100, mean age 61 ± 15 years, 56% men) were prospectively r…
- Validation of a hand-held ultrasound device in the evaluation of aortic stenosis. (opens in new tab)
- Zubiaur J, de Margarida Castro A, Pérez-Barquín R, et al.· Int J Cardiovasc Imaging· 2025
- Hand-held ultrasound devices (HHUD) are increasingly used in routine clinical practice, though they lacked continuous (CW) Doppler capability until recent times. There is limited evidence on the utility of HHUD in assessing aortic stenosis (AS) in real-world settings. Our goal was to validate a new HHUD with CW Doppler assessing AS hemodynamic severity. An observational, single-center study at the Valdecilla University Hospital, Santander, Spain between October 2022 and August 2023 was conducted. Patients previously diagnosed with AS were consecutively recruited. Following a reference echocar…
- Comparison of Six Handheld Ultrasound Devices by Pediatric Point of Care Ultrasound (POCUS) Experts. (opens in new tab)
- Leung SK, Dancel R, Soni RN, et al.· POCUS J· 2025
- Point of care ultrasound (POCUS) use is increasing among pediatric clinicians, but lack of access to ultrasound devices is a major barrier. The availability of pocket-sized handheld ultrasound devices ("handhelds") has improved access. However, no head-to-head comparative studies of handhelds in children have been performed to guide purchasing decisions. This cross-sectional study compared six handhelds: Butterfly iQ+™ (Butterfly Network Inc.), Clarius® (Clarius Mobile Health™), Kosmos™(EchoNous), TE Air™ (Mindray®), Vscan Air™ SL (General Electric…
- Feasibility and agreement study of a handheld ultrasound device with continuous-wave doppler in transcatheter aortic valve implantation patients. (opens in new tab)
- Margarida de Castro A, Zubiaur J, Pérez-Barquín R, et al.· Int J Cardiovasc Imaging· 2026
- The use of hand-held ultrasound devices (HHUD) is expanding in clinical practice, yet there is limited evidence regarding their role in evaluating transcatheter aortic valve implantation (TAVI). This study assessed the concordance between measurements obtained using an HHUD with continuous wave Doppler (CW) capability and a reference ultrasound system in patients with TAVI prostheses. A prospective, single-centre observational study was conducted in patients with TAVI prostheses. Following a reference echocardiogram by an expert operator, a second blinded evaluation was performed using a HHUD…
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