FDA Clearance & Patented Technology

Patented Technology with FDA Clearance

FDA Clearance:

The AfibAlert® is cleared by the FDA, thus you can have confidence that the device will do what we claim it to do. Some of the testing involved in preparing for the FDA review included running the algorithm used in the AfibAlert® against over 51,000 pre diagnosed ECG strips to determine the accuracy which is over 94%.

Patented Technology:

Innovation is at the heart of what we do at Lohman Technologies and supported by the patents we have been awarded.

Early on, we believed in the importance of providing patients and physicians the ability to monitor their heart rhythms on a long term basis anywhere and anytime. In addition, we felt it was equally important to provide the patient or user of the device instant feedback. We were successful in patenting our know how in this space with our Long Term Atrial Fibrillation Monitor Patent and our Long Term Cardiac Monitor patent.

As we designed devices, we are always looking for innovative ways to make it easier for patients and physicians to use them. One of our Ease of Use innovations was around the way batteries can be placed in the AfibAlert. Our engineers figured out a non-mechanical way to allow for batteries to be placed in any direction when inserted removing the need to try to see a “+” or “-“ on the inside of a battery compartment. This innovation is recognized in our Low Voltage Polarity Correcting DC to DC Converter Patent.

Our history in innovation around cardiac monitoring goes way back to when we invented memory loop recording to allow event recorders to capture the pre and post ECG recordings from when an event was detected by a patient. We felt it was also important to keep recording while this data was being transmitted to ensure both quality and accuracy in how we captured a patient’s ECG. Our innovations in this area are recognized in our Memory Loop ECG Recorder with Continuous Recording patent.

 

What patients and physicians are saying:

"It is the right kind of solution for patients, because it's a lifetime solution and Afib is a lifetime condition. I'm very impressed by the device."
Dr. Hugh Calkins, MD, Director, Cardiac Arrhythmia Service, Professor of Medicine
Physician
"I wish I had had it years ago, so I wouldn't have visited the ER so often…"
Frank (patient)
Patient
"The algorithm for detecting atrial fibrillation is extremely accurate. Another benefit to me has been the quality of the strips recorded compared to other single lead heart rhythm monitors. These high quality recordings are useful in identifying and monitoring other conditions as well as afib recurrence."
Robert Baker, MD, FACC, Nevada Cardiology Associates
Physician
"I have had the monitor for several years and have to tell you that this unit has saved my wife and I many days of anxiety and stress in knowing that I was not in Afib…"
Sherman (patient)
Patient
"The AfibAlert is beneficial in the clinical research arena to monitor for recurrence of atrial fibrillation after ablation. The quality of the ECGs it captures is excellent. In addition, patients find it extremely easy to use which yields high compliance"
John N. Catanzaro, MD, Assistant Professor of Medicine, University of Florida Health - Jacksonville
Physician
"I've had my AfibAlert for about nine months (Afib, for four years). It is easy to use and has taught me a lot about my particular Afib patterns. My meds were keeping my heart rate down most of the time and so I thought I wasn't fibrillating unless I had one of the big, obvious episodes; the monitor taught me that I was fibrillating quite often at low heart rates, too. I'm not sure I would ever have figured this out by myself. I only wish I had discovered AfibAlert a year or two earlier."
Mary (patient)
Patient
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