Medical devices & diagnostics · Cardiac monitoring

HelpWear

A Toronto company building an arm worn ECG monitor meant to be kept on for months rather than days. Licensed for sale in Canada since 2022, still labelled investigational in the United States, and still running the studies that would settle how well it performs.

A broken leg at the bottom of the stairs

Frank Nguyen came home from school and found his mother at the bottom of the staircase with a broken leg. Doctors worked out that a minor cardiac event had caused the fall. There was almost nothing in the record to show what that event had been.

Nguyen was a Grade 12 student at Danforth Collegiate Institute in Toronto. He took the problem to his classmate Andre Bertram. Both were 17. Nguyen had been picked for a summer entrepreneurship program at Ryerson University, was handed $1,000, and built a team. The first prototype was a chunky yellow box strapped to the wrist with velcro, reading blood flow with a green light.

Eleven years on, the device is worn on the bicep, reads a real electrocardiogram off metal electrodes, and holds a Canadian licence. The company has still not published a peer reviewed validation study.

The gap it is aimed at

Ambulatory ECG monitoring has a shape problem. Holter monitors, patches and mobile cardiac telemetry stick to the skin and come off within about thirty days, because adhesive eventually fails. Implantable loop recorders last years, but require a procedure and a device under the chest wall.

In between sits the patient HelpWear aims at: discharged after a stroke with no identified cause, or fainting without explanation. Guidelines recommend rhythm monitoring for both, because atrial fibrillation moves a stroke patient onto anticoagulants, and a pause or a block puts a syncope patient in line for a pacemaker. The company argues on its site that only extended monitoring can document the arrhythmia or rule one out.

That framing is the company’s. The engineering claim underneath it is testable: a dry metal electrode on the arm, with no adhesive, should stay on far longer than a patch, and the signal should still be good enough for a cardiologist to measure intervals on.

Two teenagers and a trialist

Bertram went on to Systems Design Engineering at Waterloo, Nguyen to Computer Engineering. They ran the company out of the Biomedical Zone, an incubator inside St. Michael’s Hospital, won a string of student competitions, went through Y Combinator in Summer 2017, and pitched on CBC’s Dragons’ Den, asking $100,000 for 10 percent. All six Dragons invested.

The decision that mattered more came in May 2019, when Dr. Derek Exner joined as chief medical officer and third co-founder. Exner is a practising electrophysiologist, Canada Research Chair in Cardiovascular Clinical Trials, and associate dean at the University of Calgary’s Cumming School of Medicine. The clinical work moved to Calgary, and every registered study since runs at Foothills Medical Centre or the University of Calgary.

From a watch to a medical device

The early pitch was consumer shaped: a wrist device with a SIM card that would call an ambulance when it detected a heart attack. The patent granted in June 2022 still describes that system. The product sold today is narrower and more defensible: a prescription ECG recorder worn on the upper arm, paired to a phone app for symptom tagging, with recordings read afterward by certified cardiac technicians and reported to a physician.

Health Canada issued licence 108443 on October 24, 2022, covering HEARTWATCH and HEARTWATCH STRAP as a Class II system. It was still issued and active at the database refresh of September 22, 2026, with no cancellation date. The United States is a different story, and the company says so on every product page.

Who runs it now

The company site in September 2026 lists Scott Klein as chief executive, a biomedical engineer with 25 years in cardiology medtech at Medtronic and Abbott, with Exner as chief medical officer. A March 2025 association profile adds Bertram as chairman and Owen Gillett as vice president of engineering. Nguyen, Ascend Canada’s Innovator of the Year in 2019 as chief technical officer, is on neither list. Headcount was tracked at 18 in August 2026.

What is proven, and what is still claimed

Read plainly: a licensed Canadian device with a clear regulatory footing at home, an active clinical programme, and no published evidence. Three of the four registered studies compare the HeartWatch signal against a Holter or a standard tracing, the right question for a new electrode design, and none has posted a result. The distance between the 2018 talk of imminent FDA approval and the empty FDA record today is worth holding in mind when reading anything the company says about timing.

What to watch

• Primary completion of NCT06164808, the 300 patient telemetry comparison, estimated for December 31, 2026.
• A first peer reviewed publication, or posted results from the completed 144 patient feasibility study.
• Any FDA submission at all. Until one appears, the US pages keep the investigational caution.
• CLONE data. Collection finished in March 2026; completion is estimated for August 1, 2027.

In their words

HelpWear funding profile on HVCFHealthcare Venture Capital Fund

Related companies

• Zeit Medical: Also in Medical Devices. A soft EEG headband built to notice a stroke while its wearer is asleep and raise the alarm before anyone else can
• Makani Science: Also in Medical Devices. A bandage-sized strain sensor that reads breathing off the chest and the belly
• Revolve Surgical: Also in Medical Devices. A Toronto company building a laparoscopic robot that clamps to the operating table instead of filling the room
• Standard Cyborg: Also in Medical Devices. A Y Combinator startup that printed shower legs for amputees, became the software prosthetists used to design sockets, then became a computer vision SDK

Sources

1. Public recordHealth Canada MDALL licence 108443, HEARTWATCH and HEARTWATCH STRAPHealth Canada · queried Sep 23, 2026
2. Public recordHealth Canada MDALL company record, HELPWEAR INC.Health Canada · queried Sep 23, 2026
3. Public recordopenFDA 510(k), PMA, registration and UDI queries, all with no matchopenFDA · Sep 23, 2026
4. Public recordClinicalTrials.gov NCT05821465, ALERT FeasibilityFirst posted Apr 20, 2023
5. Public recordClinicalTrials.gov NCT06164808, Conventional vs HeartWatchFirst posted Dec 11, 2023
6. Public recordClinicalTrials.gov NCT07624435, CLONEFirst posted Jun 3, 2026
7. Public recordUS Patent 11,363,958, plus applications 20200029840 and 20210345932USPTO · granted Jun 21, 2022
8. IndependentThe boys with the heart of goldThe Eyeopener, David Lao · Sep 16, 2015
9. IndependentSAGE World Cup 2016 winners: HelpWear TechMAKO Design · Aug 17, 2016
10. IndependentDuo backed by all 6 DragonsMAKO Design · Feb 13, 2018
11. IndependentHow to be a medtech entrepreneur before leaving your teensFinancial Post, Denise Deveau · May 10, 2018
12. IndependentTorontonians who are shaking up the tech sectorToronto Life · May 28, 2018
13. IndependentHelpWear taps Canada Research Chair Derek ExnerBetaKit, Isabelle Kirkwood · May 13, 2019
14. IndependentIntroducing the TMCx Spring 2020 cohortTexas Medical Center · Apr 24, 2020
15. Independent2019 Ascend Canada leadership award winnersAscend Canada · May 13, 2019
16. IndependentHelpWear company profile, incorporation and headcountTracxn · accessed Sep 23, 2026
17. CompanyHelpWear website, product and company pageshelpwear.ca · accessed Sep 23, 2026
18. CompanyIngenuity meets heart health with the HeartWatchHospital News, Andre Bertram · Jun 27, 2018
19. PartnerHelpWear portfolio profileUCeed, University of Calgary
20. PartnerHelpWear Inc. member profile, leadership listCanadian Medtech Alliance · Mar 3, 2025
21. CompanyHelpWear company pageLinkedIn · accessed Sep 23, 2026