About our project
In our video we show an example of how Spaulding Clinical has utilized mobile ECG capture to revolutionize clinical research globally. Utilizing our existing equipment gives us an advantage of not having to start from scratch. This means the project will cost less to bring to fruition and we have a much better chance of avoiding risks and challenges faced when typically starting from scratch.
The Problem we solve:
Access. We hear day in and day out that people lack access to reliable affordable care. Our device is lightweight and inexpensive. It will empower any end user to accurately collect the proper data to allow a team of professionals help diagnose cardiovascular issues from anywhere.
Our Solution
We have developed a hand held 2 oz. electrocardiograph that will stream ECG data real time to virtually any Bluetooth device. You then have the ability to transmit that data anywhere in the world. With our device, anyone anywhere will be equipped with the ability to capture a hospital quality ECG. Utilizing our software you will have the ability to send your ECG record to your physician or have a cardiologist in the Spaulding Clinical network provide you with health recommendations.
How (your product name) Works:
Our device can use the standard lead set clinicians are used to or has a cable that will work with a third party lead set called the EKG Glove (used for lay person)
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Clinical Proof to date
The USB clinical version of our device is already in the field being used in clinical research.
FDA Status
We are currently putting togather our 510K for submission to the regulatory agency. We have to adjust our submission to meet at least IEC 60601-1-11, IEC 62366. We are in the process of scheduling a call with the agency for direction on our product.
How We Help Patients:
Cardiovascular related issues are the top killer of Americans and are truly a global issue. Our device can assist in getting proper diagnosis of cardiac related issues prior to an incident happening without the cost associated with having it completed at the hospital.
How We Help Doctors (or Other Care Givers)
Although our device will work in the hospital and clinical setting. It will really help doctors and healthcare providers that are mobile. The clinicians that are in the remote areas of the country and the world. Our device will stream right to their phones or tablets and not burden them with weight.
How We Help Hospitals, Institutions, and/ or Medical Facilities:
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How We Help Our Partners:
Our device can work in any market that currently takes ECG’s for health related needs. Insurance exams, Educational institutions, Hospitals, traveling nurses, clinical research, etc.
How We Will Spend Your Contributions
We want to take our device to the next level by gaining FDA approval for use in the home and adding Bluetooth wireless capability. [Build into sentences the following]
Completion of our software and production
Testing for FDA compliance
Regulatory submissions
Production and Distribution of our device
Who We Are
[More bio info, LinkedIn profile links]
Founders : Randol Spaulding
Chief Medical Officer: Dr. Jay Mason
CTO / Engineering Lead – Brock Heinz
VP Spaulding Medical– Joe Erato
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Have a question?
If the info above does not help, you can ask the project creator directly.
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