Saranas

Houston, TX All United States companies → — Founded 2011

Medical Device / Hardware Point-of-Care Diagnostics

Cardiology Interventional Radiology Vascular Surgery

Cardiology AI Clinical Decision Support & Reference

Acquired — $30.3M

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Products

Saranas Early Bird Bleed Monitoring System

Saranas

Cardiology AI

The Saranas Early Bird Bleed Monitoring System offers real-time detection and monitoring of transcatheter intervention vascular access site bleed complications.

See all 1 product →

About Saranas

Saranas Inc. is a privately held medical device company dedicated to improving patient outcomes by providing real-time detection and monitoring of internal bleeding complications associated with vascular access procedures. The company’s flagship product, the Early Bird® Bleed Monitoring System, is the first and only FDA-approved system of its kind for early bleed detection during endovascular procedures.

The Early Bird system integrates a bleed detection array with embedded electrodes into a fully functional vascular access sheath. This innovative technology measures changes in bioimpedance to detect and monitor extravascular fluid accumulation, signaling potential bleeding from vessel injury during complex interventions such as transcatheter aortic valve replacement (TAVR), mechanical circulatory support (MCS) device placement, and other procedures where the femoral artery or vein is used for access. Visual and audible indicators alert clinicians to the onset and progression of bleeding events, enabling immediate intervention to mitigate downstream consequences, reduce costly complications, and enhance patient safety and experience.

Recent clinical data from the SAFE-MCS study, presented in March 2024, demonstrated a significant reduction in bleeding academic research consortium (BARC) type III or V access site bleeds among patients monitored with the Early Bird system compared to historical controls. This highlights the system’s potential to establish early bleed detection and monitoring as a standard of care for patients undergoing endovascular procedures.

What Physicians Need to Know

Specialization

Saranas specializes in the early detection and real-time monitoring of internal bleeding complications, particularly during and after large-bore endovascular procedures such as transcatheter aortic valve replacement (TAVR) and mechanical circulatory support (MCS) device placement.

Key Product

Their flagship product is the Early Birdu00ae Bleed Monitoring System, which is the first and only FDA-approved device for early bleed detection.

Technology & Differentiators

The Early Bird system utilizes a patented bioimpedance technology embedded within a fully functional vascular access sheath. It measures changes in electrical resistance across the blood vessel to detect and monitor bleeding in real-time, providing immediate visual and audible indicators to clinicians. This contrasts with traditional methods that rely on symptom development, enabling earlier intervention.

Clinical Impact

Clinical studies have demonstrated a high level of agreement with CT scans (the gold standard) for bleed detection, showing nearly perfect concordance and 100% sensitivity.

Physician Tip

For physicians, Saranas's Early Bird system offers a critical advantage by providing real-time, objective data on internal bleeding. This enables immediate intervention, which can significantly mitigate the severity of bleeding complications, improve patient outcomes, reduce hospital length of stay, and lower overall healthcare costs. The system's integration into a standard vascular access sheath and clear visual/audible alerts simplify its use in complex endovascular procedures, allowing for proactive bleed management rather than reactive treatment of symptoms.

The Early Bird Bleed Monitoring System is primarily a self-contained medical device integrated directly into the vascular access sheath. While it provides critical real-time data to the clinician, the design prioritizes immediate feedback through visual and audible indicators, rather than extensive external data connectivity or complex IT system integrations.

At a glance

Founded 2011

HQ Houston, TX · United States

Team size 10-20

CEO Mike MacKinnon

Funding Acquired — $30.3M

Products 1

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Products by Saranas

1 product in the directory

Saranas Early Bird Bleed Monitoring System

Saranas

Cardiology AI

The Saranas Early Bird Bleed Monitoring System offers real-time detection and monitoring of transcatheter intervention vascular access site bleed complications.

What the Web Says

Saranas is a medical device company based in Houston, Texas, specializing in innovative solutions for real-time monitoring of patients' vascular health. Their primary product, the Early Birdu00ae Bleed Monitoring System, is designed for vascular access procedures to detect and monitor internal bleeding complications early, aiming to improve patient outcomes and lower healthcare costs. The company has received positive feedback for its professionalism, reliability, and responsive staff.

Overall: Positive

Strengths

Innovative technology for real-time monitoring of vascular health.
Early detection of internal bleeding complications.
Potential to reduce bleeding complications and healthcare costs.
Professional and reliable in the medical device sector.
Responsive and supportive staff.
Great people with a clear vision and knowledgeable.

Limitations

Limited public reviews available on major platforms like G2, Glassdoor, Capterra, and Reddit.
Only one employee review found on Indeed, dating back to 2015.
Only one employee review found on Comparably, with no specific pros or cons mentioned.
No specific product reviews from healthcare IT reviewers or Reddit were found.

Based on reviews from: Trustima, Indeed.com, PitchBook, iData Research, Medical Device Network, Saranas Press Release, Saranas Website, Comparably

Last updated: 2026-07-19

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Press & Coverage

BioSpace

Saranas Successfully Completes Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

Saranas, Inc. announced the successful completion of enrollment in its SAFE-MCS clinical trial, which evaluates the Early Birdu00ae Bleed Monitoring System in patients undergoing complex high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS). The Early Bird system is the first and only FDA-approved bleed detection system.

2023-09

Business Wire

Saranas Reaches Midpoint for Enrollment in Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

Saranas, Inc. announced reaching the midpoint for enrollment in its SAFE-MCS clinical trial, evaluating the Early Birdu00ae Bleed Monitoring System for early bleed detection in patients undergoing complex high-risk PCI with MCS. The study aims to provide insights into the frequency of bleeding incidents during these procedures.

2023-03

Business Wire

Saranas Announces Over 1,200 Patients Treated with the Early Birdu00ae Bleed Monitoring System

Saranas, Inc. announced that over 1,200 patients have been treated with its Early Birdu00ae Bleed Monitoring System, the first and only FDA-approved bleed detection system. The device, launched in 2019, uses bioimpedance sensors to monitor and detect endovascular bleed complications.

2022-11

Baird Capital

Venture Capital Team Invests in Saranas

Saranas, Inc. announced a $12.8 million Series B investment led by Baird Capital and S3 Ventures. This funding will accelerate the commercialization of the Early Birdu00ae Bleed Monitoring System and support the expansion of clinical evidence.

2021-07

MedTech Innovator

Saranas snags $12.8M Series B

Houston-based Saranas Inc. closed a $12.8 million Series B investment, with funds aimed at continuing clinical trials and launching next-generation products. The company's Early Bird Bleed Monitoring System received FDA approval in 2019.

2021-07

Business Wire

Saranas Announces Peer-Reviewed Publications Highlighting Accuracy and Clinical Utility of Early Birdu00ae Bleed Monitoring System

Saranas, Inc. announced the online publication of two peer-reviewed articles in the Journal of Invasive Cardiology, highlighting the accuracy and performance of the Early Birdu00ae Bleed Monitoring System in detecting internal bleed complications.

2020-06

HMP Global Learning Network

FDA Grants Saranas De Novo Designation for the Early Bird Bleed Monitoring System

Saranas Inc. received De Novo classification from the FDA for its Early Bird Bleed Monitoring System, the first and only device for real-time detection and monitoring of internal bleeding during endovascular procedures.

2019-03

PubMed (Journal of Invasive Cardiology)

First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events

This peer-reviewed study evaluated the safety and accuracy of the Early Bird Bleed Monitoring System for detecting access-site related bleeds in humans undergoing endovascular procedures, concluding that the system was safe and highly accurate.

2020-06

Frequently Asked Questions

What is Saranas's primary product and how does it benefit patient care?

Saranas's primary product is the Early Birdu00ae Bleed Monitoring System, a medical device designed for the early detection and monitoring of internal bleeding complications during and after vascular access procedures. This system utilizes a vascular access sheath with embedded bioimpedance sensors to detect changes in electrical resistance, providing real-time alerts to clinicians about potential bleeds before they become clinically significant, thereby improving patient outcomes and potentially lowering healthcare costs.

How does Saranas's technology leverage advanced algorithms or AI to improve patient outcomes?

The Early Birdu00ae Bleed Monitoring System employs an algorithm to analyze bioimpedance changes, which are measured by integrated electrodes in the vascular access sheath, to detect and monitor extravascular fluid accumulation indicative of internal bleeding. This algorithmic processing allows for early identification of potential bleeding complications, enabling physicians to intervene proactively and mitigate adverse events.

What regulatory clearances and compliance measures does Saranas have in place for its medical devices?

Saranas received de novo classification from the U.S. Food and Drug Administration (FDA) for its Early Birdu00ae Bleed Monitoring System in March 2019, making it the first and only FDA-approved bleed detection system of its kind. The company adheres to FDA requirements for medical devices, including registration, listing, labeling, medical device reporting, and quality systems regulations.

How is the pricing structured for the Early Birdu00ae Bleed Monitoring System, and what factors influence the cost for healthcare providers?

While specific pricing details are not publicly disclosed, Saranas has secured group purchasing agreements, such as with Premier Inc., to offer special pricing and access to its Early Birdu00ae system for their network of hospitals and health systems. The overall cost for healthcare providers would typically be influenced by factors such as negotiated contracts, volume, and the potential for reduced costs associated with mitigating bleeding complications and shorter hospital stays.

What kind of clinical and technical support does Saranas offer to ensure effective integration and use of its system?

Saranas aims to ensure seamless integration of the Early Birdu00ae system into existing endovascular procedural workflows and protocols. While specific details on support programs are not extensively detailed in public information, the company's commitment to clinical evidence through trials like SAFE-MCS suggests a focus on supporting effective and safe use.

Does Saranas engage in partnerships with other healthcare organizations or technology providers?

Yes, Saranas has established partnerships within the healthcare industry, including a group purchasing agreement with Premier Inc. to expand access to its technology. Additionally, Saranas collaborates with organizations like the Cardiovascular Research Foundation (CRF) Clinical Trials Center for studies assessing the cost savings and utility of the Early Birdu00ae system.

What is the current company status and long-term stability of Saranas, particularly given the investment landscape in medical technology?

Saranas, a privately held medical device company, demonstrated stability through multiple funding rounds, raising over $30 million from investors like Baird Capital and S3 Ventures. The company was acquired on July 15, 2024, by Johnson & Johnson, indicating a strong validation of its technology and providing significant long-term stability and resources.