Timeline

April 2024

Results from 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

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…

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…

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…

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…

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…

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…

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…

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…

MindRhythm Expands Stroke License to Include Diagnosis and Recovery From Concussion

By Beth Johnson | October 26, 2022 |

MindRhythm, a medical device technology company focused on preventing neurological injury, announces today the expansion of its exclusive worldwide stroke licensing agreement with University of California San Francisco (UCSF) to include concussion. The agreement was originally executed in December 2020 to support the successful development of MindRhythm’s Harmony headset for the detection of stroke following…

MindRhythm Expands EMS Stroke Trial to California

By Beth Johnson | October 11, 2022 |

MindRhythm, a medical device technology company focused on preventing neurological injury, announces today the expansion of part 1 of its first multicenter clinical trial in stroke to 2 additional sites in California. The trial is based out of Wayne State University in Detroit, in partnership with Henry Ford, Detroit Receiving, Sinai-Grace, and Ascension St. John…

Timeline

December 2023

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

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 Trial

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

Phase I of EPISODE Prehospital Stroke Triage Trial Completed

November 2022

Preliminary Results of EPISODE Prehospital Trial Presented at SVIN

August 2022

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

June 2022

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

January 2022

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

October 2021

Second Generation 5.0 Headset Designed with Enhancements Informed by Episode Trial

April 2021

First Patient Enrolled in EPISODE Prehospital Stroke Trial on Stroke Triage

March 2021

FDA Strategy and Device Development with MRC Global and Starfish Group

February 2021

Part 1 of EPISODE Prehospital Stroke Trial 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

Timeline

December 2023

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

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 Trial

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

Phase I of EPISODE Prehospital Stroke Triage Trial Completed

November 2022

Preliminary Results of EPISODE Prehospital Trial Presented at SVIN

August 2022

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

June 2022

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

January 2022

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

October 2021

Second Generation 5.0 Headset Designed with Enhancements Informed by Episode Trial

April 2021

First Patient Enrolled in EPISODE Prehospital Stroke Trial on Stroke Triage

March 2021

FDA Strategy and Device Development with MRC Global and Starfish Group

February 2021

Part 1 of EPISODE Prehospital Stroke Trial 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

Announcing MindRhythm’s $5m Seed Funding Round

By John Keane | August 24, 2021 |

We have some exciting news to share at MindRhythm today: we’ve closed our $5 million seed round! This is an important milestone for the company and sets us up strongly for success.

Discussing MindRhythm with the Mastering Medical Device Podcast

By John Keane | August 4, 2021 |
Mastering Medical Device - MindRhythm John Keane Interview

I recently had an engaging conversation with Pat Kothe, host of the Mastering Medical Device podcast, about my background, MindRhythm’s mission, and what lies ahead for the company. I’ve summarized some of what we discussed below, but I invite you to take a listen to the episode on the podcast’s website, via Apple Podcasts, on…

MindRhythm Expands Prehospital Trial on Stroke Triage to Henry Ford Hospital

By John Keane | July 29, 2021 |

MindRhythm, a medical technology company focused on preventing neurological injury in stroke, today announced the expansion of its multicenter trial to Detroit-based Henry Ford Hospital, the flagship hospital of Henry Ford Health System. The trial – based out of Wayne State University and in partnership with Detroit Receiving Hospital, Sinai-Grace Hospital, and Ascension St. John Hospital – started enrolling in April and now has active enrollees at Henry Ford Hospital.

EMS World: Can a Simple Headset Detect LVO Strokes in the Field?

By John Keane | June 28, 2021 |

At the American Stroke Association’s 2015 International Stroke Conference, researchers declared that, based on overwhelming evidence, mechanical thrombectomy should be standard of care in the treatment of all large vessel occlusion (LVO) stroke patients. For the first time in history, patients experiencing one of the most debilitating types of strokes had a treatment option that…

Stroke Awareness Month: Identifying the Signs of Stroke

By John Keane | May 13, 2021 |

More than 800,000 strokes happen each year in the United States; in fact, someone in the U.S. has a stroke every 40 seconds. When you suspect that you or another person is experiencing a stroke, quick and decisive action is critical, as strokes require immediate treatment to help minimize brain injury.  In honor of Stroke Awareness…

MindRhythm Announces Launch of the Company; Enrolls First Patient in Prehospital Trial on Stroke Triage

By John Keane | April 27, 2021 |

Clinical Trial Follows Publication of Two Papers Demonstrating the Effectiveness of MindRhythm Technology  LOS ALTOS, CALIFORNIA, APRIL 27, 2021 — MindRhythm, a medical technology company focused on preventing neurological injury in stroke, today announced the enrollment of its first patient in a multicenter trial out of Wayne State University in partnership with Detroit Receiving Hospital,…

A Simple Device to Solve One of Medicine’s Biggest Problems

By John Keane | March 30, 2021 |

By: John Keane, CEO and co-founder, MindRhythm To understand how, and why, MindRhythm came to be, we have to start with the big picture.  A stroke is a sudden interruption of the blood supply to the brain, and most are caused by an abrupt blockage of arteries leading to the brain – called an ischemic…

Stroke Monitoring: the Market Problem that MindRhythm Solves (Part II)

By John Keane | March 16, 2021 |

By: John Keane, CEO and co-founder, MindRhythm This is the second blog post in a two-part series. From a societal standpoint, consumers are increasingly utilizing health tracking devices such as wearables to monitor their well-being – but people are not at all supported if and when they have a stroke. The devastating, permanent results of…

Stroke Detection: the Market Problem that MindRhythm Solves (Part I)

By John Keane | March 2, 2021 |

By: John Keane, CEO and co-founder, MindRhythm This is the first blog post in a two-part series. Stroke detection – or lack thereof – is a well-known problem, and the medical and paramedic communities have both been searching for a solution. To better understand the significance of the stroke detection problem, consider this: hospitals equip…