HeartBeam Archives - Medical Design Sourcing

HeartBeam unveils AI program for cardiac insights

HeartBeam (Nasdaq:BEAT) announced today that it made significant developments in the AI applied to its proprietary ECG technology.

Santa Clara, California-based HeartBeam develops its proprietary vectorelectrocardiography (VECG) technology. The company aims to provide diagnostic and prognostic insights about cardiac health beyond what standard 12-lead ECGs provide.

HeartBeam’s VECG technology collects 3D signals of the heart and converts them into an easy-to-interpret 12-lead ECG. The company designed it for use with portable, patient-friendly devices. Its first planned application comes in the form of the AIMIGo credit card-sized device.

The company leverages AI to analyze data-rich signals captured by the VECG, hoping to improve diagnostic accuracy and extract unique information. That includes complex heart rhythms, subtle signs of deteriorating health and potentially missed cardiac events.

According to a news release, the data collected c…

HeartBeam names Deborah Castillo VP of regulatory affairs

HeartBeam (Nasdaq:BEAT) announced today that it appointed Deborah Castillo as its VP of regulatory affairs.

Castillo, an experienced biomedical engineer, brings with her knowledge of the FDA, EU and Health Canada regulations, HeartBeam says. Her experience spans cardiovascular diseases, neuroscience and medical devices that support these functions.

Before joining HeartBeam, Castillo served as director of regulatory affairs for neuromodulation at LivaNova. From 2012 to 2018, she held a number of roles at the FDA including acting branch chief, senior lead reviewer and lead scientific reviewer.

In her role at Santa Clara, California-based HeartBeam, Castillo holds responsibilities for interactions with regulatory agencies worldwide. She also supports the company’s clinical development and commercialization efforts for HeartBeam AIMIGo. That platform technology for ECG monitoring remains under review by the FDA.

Castillo said she looks forward t…

HeartBeam adds duo of medtech veterans to its board

HeartBeam (Nasdaq:BEAT) announced today that it appointed Ken Nelson and Mark Strome to its board of directors.

The appointment of Nelson and Strome became effective on June 5, 2023. HeartBeam develops a proprietary 3D-vector ECG platform intended for patient use at home.

Nelson, 48, brings with him 20 years of experience in digital health, medical devices and remote patient monitoring. Over the past decade, he led commercial efforts for companies including BioTelemetry, iRhythm and Bardy Diagnostics. Most recently, he served as head of digital health, diagnostics and monitoring for Biotronic. Nelson currently chairs the CardiaCare board and serves as an active board member for a handful of other startups.

Strome, 66, offers HeartBeam more than 40 years of experience in investment management and securities. He serves as founder, chief investment officer and chair at Strome Investment Management and Strome Group. Previously, Strome served as portfolio man…

HeartBeam partners with Samsung to boost at-home cardiac care

HeartBeam has announced a strategic alliance agreement (SAA) with global tech giant Samsung.

The alliance, announced today, builds upon an existing SAA between Samsung and Livmor, whose assets HeartBeam acquired earlier this year.

Livmor created the FDA-cleared wearable Halo atrial fibrillation detection system — an FDA-cleared, Samsung-Galaxy-watch-based arrhythmia detection tool. Meanwhile, HeartBeam recently secured a pivotal patent related to artificial intelligence capabilities for its AIMIGo system — a personal, portable vector electrocardiogram (VECG) system. Also, this month, HeartBeam submitted AIMIGo for FDA 510(k) clearance.

This collaborative venture between HeartBeam and Samsung will explore opportunities to leverage HeartBeam’s proprietary technology and expertise in cardiac symptom assessment and monitoring. The two companies think their technologies could boost the standard of cardiac diagnostic capabilities.

HeartBeam’…

HeartBeam wins AI-related patent for handheld vector ECG

[Image courtesy of HeartBeam]HeartBeam (Nasaq:BEAT) announced today that it received a key patent relating to AI capabilities for its AIMIGo system.

The U.S. Patent and Trademark Office (USPTO) issued the allowance for a patent titled “Hand Held Device for Automatic Cardiac Risk and Diagnostic Assessment.” The patent describes a system that combines recorded cardiac signals from AIMIGo with the patient’s symptoms and cardiac risk factors. Together, this calculates a cardiac risk score to provide simplified diagnostic information and actionable instructions.

Santa Clara, California-based HeartBeam said this aims to replicate the decision-making process of a physician assessing cardiac symptoms. However, with AIMIGo, it occurs remotely and in an automated manner.

HeartBeam developed AIMIGo as a personal, portable vector electrocardiogram (VECG) system. It assists patients and clinicians in assessing cardiac symptoms. It utilizes a reusable, credit card-…

HeartBeam submits AIMIGo vector ECG for FDA 510(k) clearance

[Image courtesy of HeartBeam]HeartBeam (Nasdaq:BEAT) announced today that it submitted a 510(k) application to the FDA for its AIMIGo system.

AIMIGo, a personal, portable vector electrocardiogram (VECG) system assists patients and clinicians in assessing cardiac symptoms. It utilizes a reusable, credit card-sized VECG recording device and cloud-based software. The system can deliver critical data to clinicians in real-time outside of a medical setting.

HeartBeam’s 12-lead 3D vector electrocardiogram (ECG) device pairs with a smartphone app and cloud-based diagnostic software system. It can facilitate remote heart attack detection.

“The 510(k) submission of our HeartBeam AIMIGo VECG device is an important milestone for the company,” said Branislav Vajdic, HeartBeam CEO and founder. “We believe that our patented VECG technology holds tremendous promise to provide timely and actionable information to patients and their clinicians. This submission is the …

HeartBeam raises $23.2M

[Image courtesy of HeartBeam]HeartBeam (Nasdaq:BEAT) announced on Wednesday that it closed a secondary offering of common stock worth $23.2 million.

Santa Clara, California-based HeartBeam offered more than 16.6 million shares of its common stock. The offering amounts to net proceeds of $23.2 million after deducting placement agent discounts, commissions and offering expenses. Public Ventures LLC acted as placement agent for the offering.

HeartBeam said it expects the funds to support its upcoming clinical and regulatory milestones related to its AIMIGo system. The company aims to commercialize AIMIGo in 2024.

AIMIGo, is a credit card-sized, 12-lead 3D vector electrocardiogram (ECG) device. It pairs with a smartphone app and cloud-based diagnostic software system to facilitate remote heart attack detection. HeartBeam has yet to pick up FDA clearance for the platform.

HeartBeam has big goals for the near future

The company said it adjusted its strateg…

HeartBeam acquires patient monitoring assets from Livmor

The Livmor Halo system acquired by HeartBeam. [Image from Livmor]HeartBeam (Nasdaq:BEAT) announced today that it acquired substantially all assets from Livmor, which develops remote monitoring technology.

Livmor, a digital health solutions company, provides a patient-engaging remote monitoring system for critical physiological biomarkers.

HeartBeam said in a news release that the acquisition extends its reach in remote monitoring and detection. It now has full ownership of Livmor’s Halo AFib detection system. Livmor received FDA 510(k) clearance for the Halo wearable AFib detection system in October 2020.

The Halo system provides continuous monitoring of pulse rhythms to detect AFib on-demand during the day and automatically overnight.

HeartBeam and Livmor partnered last month to build a HeartBeam-branded version of the Halo cloud-based software platform. This collaboration allowed HeartBeam to meet its schedule for FDA submission of its AIMI s…

HeartBeam appoints new president

Rob Eno. [Image courtesy of HeartBeam]HeartBeam (Nasdaq:BEAT) announced today that it appointed Robert Eno to its newly created position of president.

Eno’s responsibilities include the company’s strategic direction, commercialization efforts and day-to-day operations. His role includes these responsibilities over the HeartBeam AIMI and HeartBeam AIMIGo platforms.

The Santa Clara, California-based company designed AIMIGo as a credit card-sized, 12-lead 3D vector electrocardiogram (ECG) device. It developed AIMI for acute care settings. AIMI provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack.

Eno said in a news release that he feels “privileged” to join HeartBeam as it prepares for a new phase of commercialization. The company said last month that it expects FDA approval for its AIMI platform this year.

“I am impressed with what the team has accomplished, and I believe th…

HeartBeam expects FDA to approve AIMI system for acute care settings in 2023

[Image courtesy of HeartBeam]In a letter to shareholders, HeartBeam (Nasdaq:BEAT) founder and CEO Branislav Vajdic laid out potential regulatory timelines for 2023.

Calling 2022 “a transformative year,” Vajdic updated the expectations for HeartBeam’s AIMIGo and AIMI systems.

The company designed AIMIGo as a credit card-sized, 12-lead 3D vector electrocardiogram (ECG) device. It developed AIMI for acute care settings. AIMI provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack.

“I could not be more enthusiastic about the future for HeartBeam, the rapid pace of our product timeline, and our team’s ability to scale our commercialization path,” Vajdic wrote.

He added that the company believes its AIMI and AIMIGo solutions can “transform” heart attack detection.

Vajdic said the company expects the FDA to approve AIMI for use in acute care settings “…

HeartBeam names new chief medical officer

[Image from Stanford University]HeartBeam (Nasdaq:BEAT) announced today that it appointed Dr. Peter Fitzgerald as its new chief medical officer (CMO).

Santa Clara, California-based HeartBeam develops a 3D-vector electrocardiogram (ECG) platform for heart attack detection.

The company said in a news release that Fitzgerald joins with “world-renowned” expertise in interventional cardiology. HeartBeam also referred to him as an “accomplished inventor, entrepreneur and investment fund founder.”

“We are thrilled to have Dr. Fitzgerald, one of the world’s preeminent opinion leaders in cardiology and digital health, join the HeartBeam leadership team and play a major role in defining best paths to adoption, clinical strategies, and partnerships to advance our products in the market,” said Branislav Vajdic, founder and CEO of HeartBeam. “In addition to his cardiovascular clinical and research expertise, Dr. Fitzgerald has a rich history of d…

HeartBeam enables smartwatch connectivity for heart monitoring

HeartBeam (Nasdaq:BEAT) announced today that it expanded its product portfolio to add arrhythmia detection capabilities to wearables.

Santa Clara, California-based HeartBeam said in a news release that it aims to serve the growing cardiac device wearable market. The pipeline advancement allows for the addition of arrhythmia detection capabilities for AFib and other arrhythmia monitoring.

The company’s broader product portfolio builds on recently issued patents, HeartBeam said. Its 12-lead electrocardiogram (ECG) patch picked up a patent last month.

HeartBeam introduced a three-lead 3D vector ECG (VECG) credit card-sized HeartBeam AIMIGo 3L device. The device records cardiac activity and displays signals for clinician review. It provides the regulatory foundation for subsequent products in the company’s portfolio. HeartBeam plans to submit to the FDA for 510(k) clearance in the fourth quarter of this year.

Additionally, the company leve…