Timeline

January 2025

First Concussed Subject Enrolled in the DISCOVERY Study: "DetectIon of ConcusSion and ReCOVERY" to Validate the Confirmation of Concussion and Objective Management of Concussion Recovery Including Subjects 4+ Years of Age

November 2024

Dr. Wade Smith Presents Key Details from the EPISODE Family of Studies at the 2024 Society of Vascular and Interventional Neurology Meeting in a Roundtable focused on a Multidiscplinary Approach to Advance Stroke Care

October 2024

Results from the Pilot Phase of EPISODE Presented by Dr. Wade Smith MD, PhD, and Dr. James Paxton, MD at American College of Emergency Physicians Annual Conference

April 2024

Results from the Pilot Phase of EPISODE Published by Academic Emergency Medicine. Results Reveal Harmony Can Reliably Identify LVO Stroke in the Prehospital Setting

December 2023

Successful Completion of Enrollment in EPISODE-VS hEadpulse for Ischemic StrOke DEtection Prehospital Study

October 2023

Dr. Wade Smith MD, PhD, Presents HeadPulse Sleep Burst Data at the World Sleep Congress Meeting in Rio de Janeiro

October 2023

FDA grants Breakthrough Device Designation for Harmony

October 2023

Best Abstract of the Year Awarded to Dr. James Paxton MD, Primary Investigator of “hEadPulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic by American College of Emergency Physicians

August 2023

"Analysis of HeadPulse Biometric Measures Following Concussion In Young Adult Athletes" Published in JAMA Network Open

June 2023

First Patient Enrolled in Pivotal FDA Portion of EPISODE Prehospital LVO Stroke Triage Study

March 2023

Validation of HeadPulse in Recently Concussed Athletes Manuscript Submitted For Publication Officially Entitled:

"Analysis of HeadPulse Biometric Measures Following Concussion in Young Adult Athletes"

March 2023

Preliminary Results Published in Journal of Stroke Vascular Interventional Neurology of EPISODE-The First Prehospital Study of a Stroke Device

January 2023

Pilot Phase of EPISODE Prehospital Stroke Triage Study Completed

November 2022

Preliminary Results of EPISODE Prehospital Study Presented at SVIN

August 2022

EPISODE Prehospital Stroke Study on Stroke Triage Site Expansion to UCSF and CPMC Approved

June 2022

Generation 5.0 Harmony Headset Introduced to EPISODE Prehospital Stroke Study on Stroke Triage

January 2022

EPISODE Prehospital Stroke Study on Stroke Triage Site Expands to Western Michigan and Kalamazoo

October 2021

Second Generation 5.0 Headset Designed with Enhancements Informed by User Feedback from Pilot Phase of EPISODE Study

April 2021

First Patient Enrolled in EPISODE Prehospital Stroke Study on Stroke Triage

March 2021

FDA Strategy and Device Development with MRC Global and Starfish Group

February 2021

Pilot Phase of EPISODE Prehospital Stroke Study on Stroke Triage Begins in Detroit at Wayne State University

January 2021

Formation of Board

Corey Goodman appointed Chairman

December 2020

Executed License Agreement with UCSF for Research and Commercialization in Stroke

November 2020

Completion of Generation 4.0 Headset

July 2019

MindRhythm Incorporated

EPISODE Family of Studies Principal Investigator Dr. James Paxton Featured on Skeptics’ Guide to Emergency Medicine

By Beth Johnson | October 14, 2024

On October 2, 2024, hosts of the Skeptics’ Guide to Emergency Medicine podcast featured EPISODE principal investigator, Dr. James Paxton to discuss the qualities and results of the pilot phase of the EPISODE study. The SGEM podcast is affiliated with the Society of Academic Emergency Medicine has a 12 year international following, and is 4.5 star rated. The podcast is part of the Free Open Access to Meducation, providing medical education to anyone, anywhere, anytime. Opening the episode, the hosts reminded the audience that prehospital identification of stroke remains a significant challenge in stroke care. Effective tools to address this…

Read More

Pilot Results from EPISODE Family of Studies Published in Academic Emergency Medicine Reveals Harmony Can Reliably Detect LVO in the Prehospital Setting

By Beth Johnson | April 23, 2024
Read More

MindRhythm Completes Enrollment in its Multicenter Prehospital Trial for Identifying Large Vessel Occlusion Stroke

By Beth Johnson | December 4, 2023

December 4, 2023 MindRhythm Incorporated, a neurodiagnostic technology company based out of Cupertino, California, today announced that it reached the number of patients required to complete enrollment in its pivotal stroke trial-EPISODE. This trial was designed to validate that MindRhythm’s Harmony can accurately identify LVO stroke prehospital, with the goal of improving triage decisions. Better quality information will help EMS teams ensure a critical patient is transported to a hospital equipped with the necessary treatment resources. Proper triage can be the the difference between life, death, and debilitation.  EPISODE-hEadpulse for Ischemic StrOke DEtection Prehospital, is a large, EMS based study that…

Read More

Harmony, MindRhythm’s Innovative Device for LVO Stroke, Granted Breakthrough Device Designation by the FDA

By Beth Johnson | November 1, 2023

The FDA has awarded a Breakthrough Device Designation for MindRhythm’s Harmony headset embedded with HeadPulse technology. The function of MindRhythm’s Harmony device is to aid in the assessment of suspected stroke patients in the prehospital setting to determine whether the patient may have a large vessel occlusion (LVO) stroke. LVO strokes are among the most debilitating types of strokes. The FDA describes the Breakthrough Devices Program as “a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” The program considers the potential for…

Read More

MindRhythm Announces Publication in JAMA Network Open of Novel Headset for Return to Play Decisions in Concussion

By Beth Johnson | September 1, 2023

CUPERTINO, CALIFORNIA, UNITED STATES, August 11, 2023/EINPresswire.com/ — MindRhythm Inc, in collaboration with the University of California San Francisco (UCSF), announces publication of the manuscript titled “Analysis of HeadPulse Biometric Measures Following Concussion in Young Adult Athletes” released today in the journal, JAMA Network Open. The findings indicate that digital measurement of the HeadPulse, using MindRhythm’s proprietary headset, provides an objective measure of concussion status. The HeadPulse, discovered by MindRhythm and researchers at UCSF, provides evidence of normal and abnormal brain function in a variety of neurological conditions. Results suggest that HeadPulse is the first digital biometric that can be used to…

Read More

EMS World: How a Simple Headset Can Solve the Triage Problem in Stroke

By John Keane | July 20, 2023

In an article published by EMS World back in June of 2021, it was postulated that MindRhythm’s rapid, disposable, noninvasive Harmony headset could detect Large Vessel Occlusion strokes in the field.  At the time, MindRhythm had preliminary, hospital-based data suggesting the device could accurately identify LVO strokes.  However, the company felt strongly that it was important to engage in a prehospital trial to demonstrate efficacy in the arena in which the device would be used. Since that time, MindRhythm has partnered with EMS facilities in multiple states as well as their respective receiving hospitals to collect initial data to support its hypotheses…

Read More

MindRhythm Announces First Patient Enrolled in Pivotal Study of Novel Harmony™ Device for Rapid Detection of Stroke

By Beth Johnson | June 20, 2023

CUPERTINO, CALIFORNIA, USA, June 20, 2023/EINPresswire.com/ — MindRhythm Inc, in partnership with Wayne State University School of Medicine in Detroit, Michigan, today announced that the first patient has been enrolled in the pivotal portion of its HeadPulse for Ischemic Stroke Detection Prehospital Study (EPISODE-VS). EPISODE-VS is designed to validate that the use of MindRhythm’s proprietary Harmony headset can rapidly identify large vessel occlusion (LVO) ischemic strokes in the prehospital setting to optimize triage and improve stroke outcomes.  “Stroke is the leading cause of sudden disability and the fifth leading cause of death in the US,” said John Keane, Co-Founder and CEO of…

Read More

CEO John Keane Featured on NPR for Comment on SVB Crisis and Its Impact on Emerging Businesses

By Beth Johnson | April 3, 2023

Days after Silicon Valley Bank’s collapse prompted customers to line up in order to get their money out, the California bank is asking them to come back. “The number one thing you can do to support the future of this institution is to help us rebuild our deposit base, both by leaving deposits with Silicon Valley Bridge Bank and transferring back deposits that left over the last several days,” said Tim Mayopoulos, the bank’s new CEO, in a note posted on the company’s LinkedIn page. WBUR is a nonprofit news organization. Our coverage relies on your financial support. If you value articles like the…

Read More

The Journal of Stroke Vascular and Interventional Neurology Publishes EPISODE-PS Initial Trial Results

By Beth Johnson | March 16, 2023

CUPERTINO, CALIFORNIA, UNITED STATES, March 16, 2023 /EINPresswire.com/ — MindRhythm Inc, in partnership with Wayne State University School of Medicine in Detroit, Michigan, today announces the first publication of results from the hEadPulse for Ischemic StrOke DEtection Prehospital Study (EPISODE-PS) trial.  The EPISODE-PS trial was designed to evaluate the use of MindRhythm’s proprietary Harmony headset technology for identifying large vessel occlusion (LVO) ischemic strokes in the prehospital setting. It is believed that the EPISODE-PS study is the first stroke device study to target patients in the prehospital environment, testing the theory that this device can detect LVO ischemic strokes even…

Read More

MindRhythm Initiates Pivotal Portion of Prehospital Stroke Trial

By Beth Johnson | February 15, 2023

CUPERTINO, CALIFORNIA, UNITED STATES, February 14, 2023 /EINPresswire.com/ — MindRhythm Inc, in partnership with Wayne State University School of Medicine in Detroit, Michigan, today announces the conclusion of phase I and initiation of the pivotal portion of its hEadPulse for Ischemic StrOke DEtection Prehospital Study (EPISODE-VS). The EPISODE trial is designed to evaluate the use of MindRhythm’s proprietary Harmony headset technology for identifying large vessel occlusion (LVO) ischemic strokes in the prehospital setting. In previous studies, cranial accelerometry, the primary technology used in the Harmony headset, has been shown to reliably detect LVO in hospitalized patients suspected of experiencing an ischemic stroke.…

Read More