MIMOSA Imager
Regulatory Status Disclosed
Overview
MIMOSA Pro is a handheld, portable imaging device that uses advanced multispectral imaging technology, leveraging near-infrared and infrared light, to non-invasively assess tissue health. It captures critical physiological biomarkers such as tissue oximetry, temperature, and wound measurements, along with HDR digital images, in less than one second without requiring patient contact. The device provides AI-driven insights in real-time at the point-of-care, aiding clinicians in making informed decisions about patient care. Images and data are uploaded to a secure, cloud-based web portal, enabling remote monitoring, tracking of patient progress over time, and collaboration among healthcare professionals. MIMOSA Pro is designed for ease of use by any healthcare professional across various settings, including hospitals, group practices, home care, and in the field. A key differentiator is its ability to accurately measure tissue health across all skin tones, promoting equitable healthcare access. The technology aims to improve patient outcomes through early detection of tissue compromise and proactive adaptation of care plans, ultimately saving limbs and lives.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Handheld, portable, pocket-sized imaging device
- Non-contact, multispectral imaging (near-infrared and infrared light)
- Captures tissue oximetry, temperature, wound measurement, and HDR digital images in less than one second
- AI-driven insights for real-time point-of-care decisions
- Secure web portal for remote monitoring, patient progress tracking, and clinician collaboration
- Effective across all skin tones and melanin levels
- US FDA 510(k) cleared and Health Canada Approved
- Reimbursable
- Ease of use for any healthcare professional
Use Cases
- Early detection of tissue compromise
- Wound care management (including diabetic foot ulcers and pressure injuries)
- Screening and assessment for Peripheral Vascular Disease (PVD)
- Bedside tissue assessment in hospital settings
- Remote tissue assessment for home care and rural areas
- Risk triaging in various field settings
- Monitoring post-operative surgical complications
What Physicians Need to Know
Key Capabilities
Pocket-sized, non-invasive device utilizing near-infrared light to capture tissue oximetry, temperature, wound measurements, and HDR digital images in under one second. It makes sub-surface biomarkers visible, aiding in early detection of tissue compromise. Future iterations are planned to include AI-driven insights for predicting patient outcomes.
Clinical Utility
Enables early intervention for improved patient outcomes by visualizing physiological biomarkers below the skin's surface, which can lead to saving limbs and lives. It supports proactive adaptation of care plans, enhances access to expert care in various settings (including home care), and facilitates remote monitoring and collaboration. Particularly beneficial for identifying early-stage pressure injuries, especially in patients with darker skin tones.
Integration Options
Images are uploaded to a secure, cloud-based web portal for immediate review and remote viewing, accessible via a smartphone app connected through Wi-Fi. This architecture supports asynchronous telemedicine and seamless collaboration among healthcare professionals.
Compliance Status
The MIMOSA Pro is US FDA 510(k) cleared as a Class II medical device and is Health Canada Approved. Its web portal is HIPAA compliant, ensuring patient data security and privacy.
Pricing Model
The product is offered on a monthly subscription basis, described as a Software as a Service (SaaS) model with a hardware component (Hardware as a Service - HaaS), priced at $600 per device per month.
User Experience
Designed as a pocket-sized, handheld, and portable device, it is intended for easy use by any healthcare professional. Image capture is quick (less than one second) and managed via a user-friendly smartphone app interface.
Support Quality
Mimosa Diagnostics provides a dedicated Customer Success Team to assist users in maximizing the value of the MIMOSA Pro.
Implementation Complexity
Described as easy to set up and use, becoming operational in seconds after connecting the device app to Wi-Fi. Its portability and handheld design suggest low complexity for deployment across various healthcare settings.
Evidence Base
The technology is rooted in multispectral imaging, initially developed for burn depth detection. Bench data supports its accuracy and precision for StO2 estimation compared to gold standards. The company is actively building an AI tool to predict patient outcomes using anonymized data, with current clinical use in North America demonstrating improved outcomes.
Physician Tip
Leverage the MIMOSA Pro for early detection of tissue compromise, particularly in high-risk patients (e.g., those with diabetes or limited mobility), to enable proactive care plan adjustments. Utilize its remote viewing capabilities for efficient multidisciplinary collaboration and to extend expert care to remote or home care settings. The objective data provided (tissue oximetry, temperature, wound measurement) is invaluable for monitoring treatment efficacy and can be especially helpful for assessing early-stage injuries in patients with darker skin tones where visual cues may be less apparent.
The MIMOSA Pro integrates seamlessly with a secure, cloud-based web portal via a smartphone application. This setup facilitates remote access to patient images and physiological data, supporting asynchronous telemedicine workflows and enhancing collaboration among distributed care teams.
Details
| Category | Dermatology AI, Radiology & Imaging AI |
| Pricing | Unknown |
| Deployment | Handheld device with a smartphone app interface and a secure cloud-based web portal. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The device, referred to as MIMOSA Imager (K190334), received US FDA 510(k) clearance on November 1, 2019. It is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that maps tissue oxygen saturation (StO2) values to a spatially registered heat-map, indicated for monitoring patients during circulatory or perfusion examinations or when compromised circulation is suspected. |
| Integrations | |
| EHR | Not specified |
| Specialties | Dermatology, General Surgery, Plastic Surgery, Vascular Surgery |
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Press & Coverage
Kern Venture Group
MIMOSA Diagnostics completes latest raise to accelerate north american commercialization
MIMOSA Diagnostics successfully closed its latest financing round, led by Kern Venture Group and other investors, to fuel commercial expansion and organizational growth in North America. This funding follows the launch of their MIMOSA Pro product in the US market and Health Canada approval.
2024-06
Entrevestor
MIMOSA Breaks into U.S. Healthcare System - Entrevestor
Halifax medtech startup MIMOSA Diagnostics has gained recognition for its MIMOSA Pro as an assessment tool by U.S. Medicare and Medicaid providers, allowing for reimbursement for its use in diabetic foot and venous leg ulcer treatment. CEO Karen Cross noted that this marks a significant policy change in U.S. healthcare.
2025-02
EIN Presswire
Venture Medical and MIMOSA Announce Partnership - EIN Presswire
Venture Medical, LLC announced a national partnership with MIMOSA Diagnostics to enhance wound care providers' clinical decision capabilities by integrating MIMOSA's tissue oxygenation, perfusion, and thermal analytics with Venture Medical's solutions. This collaboration aims to increase access to point-of-care tissue viability assessment.
2024-02
INOVAIT
How MIMOSA is transforming wound care - INOVAIT
MIMOSA Diagnostics has developed the MIMOSA Pro, a pocket-sized imaging device that assesses skin injuries to enable early intervention and prevent limb loss, particularly for patients with diabetes and chronic wounds. The company is also incorporating AI to identify specific tissue health qualities for even earlier intervention.
2025-03
Higher Education Press (Journal of Clinical Medicine)
The Progress and Future of Artificial Intelligence in Nursing Care: A Review
The MIMOSA Imager is highlighted as an AI-enabled device used in ambulatory care to estimate spatial distribution of oxygen saturation in tissue for patients with suspected circulatory compromise. Its applications include predicting wound risks and guiding care programs, with the potential to improve healthcare quality and reduce costs.
2024-05
Oxford Academic (Aesthetic Surgery Journal)
Growth in FDA-Approved Artificial Intelligence Devices in Plastic Surgery: A Key Look Into the Future - Oxford Academic
The MIMOSA Imager, approved by the FDA in January 2019, is listed as an AI-enabled device used in plastic surgery for monitoring tissue viability and oxygenation levels. This article discusses the increasing presence of FDA-approved AI medical devices in healthcare, including those in plastic surgery.
2024-10
Ovid (Surgery)
FDA-approved artificial intelligence and machine learningu2013enabled medical devices in general surgery: A review based on regulatory panel classification - Ovid
The MIMOSA Imager is identified as an FDA-approved AI/ML-enabled medical device, classified as a Class II oximeter for tissue saturation, with an approval date of November 1, 2019. The article reviews the landscape of such devices in general surgery.
2024-05
FDA
K190334 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification document details the MIMOSA Imager, a cordless, non-contact tissue oximeter indicated for monitoring patients during circulatory or perfusion examinations. It estimates and maps oxygen saturation in superficial tissue.
2019-11
Videos
Product demos, reviews, and walkthroughs for MIMOSA Imager.
ShortCam II Review - Testing
Frequently Asked Questions
The MIMOSA Imager is a portable, non-contact device designed for point-of-care tissue assessment in various medical settings, including physician offices, hospitals, and home care. It captures tissue oximetry, temperature, and digital images, which are then uploaded to a secure web portal for remote monitoring and collaboration. This technology is particularly beneficial for patients requiring monitoring during circulatory or perfusion examinations, those with suspected compromised circulation, and especially in wound care for conditions like diabetic foot ulcers and pressure injuries, enabling early intervention and tracking of healing progress.
MIMOSA Diagnostics is developing an AI tool to predict patient outcomes by analyzing anonymized data from devices and linking it with patient conditions over time. This machine learning approach aims to identify specific tissue health qualities for earlier intervention. The company is also actively developing algorithms to account for skin melanin content, addressing a limitation of traditional light-based optical technologies that can be less effective on darker skin tones, thereby improving care equity.
The MIMOSA Imager (MIMOSA Pro) is US FDA 510(k) cleared and Health Canada Approved, demonstrating its adherence to established medical device standards. Patient data captured by the device is uploaded to a secure, encrypted, cloud-based web portal that is HIPAA-compliant, ensuring the protection and privacy of sensitive health information.
The MIMOSA Imager stands out due to its pocket-sized, non-contact design, which miniaturizes technology traditionally found in large, stationary machines. It utilizes multispectral imaging with near-infrared light to non-invasively assess tissue oxygen saturation, temperature, and wound measurements, providing insights not visible to the naked eye. Its ability to provide objective, real-time data at the point of care, coupled with a secure web portal for remote monitoring and collaboration, offers a significant advantage for early intervention and proactive care planning.
Specific pricing for the MIMOSA Imager is not publicly available in the provided search results; direct inquiry with MIMOSA Diagnostics is recommended for cost details. However, there is a reimbursement pathway for using the MIMOSA Pro in near-infrared spectroscopy studies of skin tissue, with Category III CPT codes (0640T, 0641T, 0642T, 0859T) available for image acquisition, interpretation, and reporting. Reimbursement is determined by third-party payers on a case-by-case basis, and prior authorization is suggested.
The MIMOSA Imager is intended as an adjunctive decision aid and should not replace good clinical diagnostic practices. Its accuracy can be affected by intense physical exercise prior to assessment, artificially heated tissue, and interference from other near-infrared light sources like direct sunlight or operating room lights. Imaging hairy or tattooed regions may also lead to inaccurate StO2 values, and patient movement can result in low-quality images.
The MIMOSA Pro is designed for ease of use by any healthcare professional, featuring a smartphone-app interface for capturing spatially-resolved images. It offers intelligent guided image capture and offline functionality, with minimal lighting restrictions. This user-friendly design aims to streamline tissue health assessments and integrate seamlessly into existing workflows.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18