HEALTH TECHNOLOGY

HeartBeam Expands Patient Population for Emergency Department Software Technology Solution

HeartBeam, Inc. | July 04, 2022 | Read time : 2 min

HeartBeam Expands

HeartBeam, Inc. a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, announced that HeartBeam is expanding the available patient population for the Company’s Emergency Department software technology solution.

In evaluating the ECG database for the clinical validation of HeartBeam’s platform technology, a significant portion of consecutive patients fell into the category of unstable angina, a serious cardiac condition. In light of the most recent 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain and in consultation with its clinical advisors, HeartBeam elected to include the full data set for clinical validation studying in support of the 510K submission. The expanded scope of the clinical validation study will provide access to a broader patient population for HeartBeam’s technology once cleared by the FDA.

Due to the expanded available patient population, HeartBeam expects to file a 510K with the full data set for clinical validation no later than August 15, 2022 and does not affect the timeline for 510K submission of the Telehealth product.

It is important to include unstable angina as a diagnosis for analysis. Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue. Given HeartBeam’s advanced technology solution, there is potential to identify patients who cannot be diagnosed by traditional ECG capabilities but may require intervention.”

Russell Jones, MD, Interventional Cardiologist, Chair of the Ischemia Performance Improvement Committee at Phoebe Putney Health System

HeartBeam’s platform technology is anticipated to assist physicians in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatment regimen. Chest pain is the second most common reason for an emergency department visit, with high costs associated with these visits. HeartBeam’s software solution may offer more accurate heart attack detection to triage patients and expedite treatment. The HeartBeam technology platform has not yet been evaluated by the FDA and is not approved for clinical use in the USA or other global geographies.

“We believe our commercialization path is on track,” said Branislav Vajdic, PhD, CEO and founder. “The decision to include the broader patient population does not impact the scheduled submission for HeartBeam’s core technology platform for our Telehealth solution, which remains on schedule to submit in Q4 2022.”

About HeartBeam, Inc.

HeartBeam, Inc. is a development stage digital healthcare company with proprietary ECG telemedicine technology that will redefine the way high risk cardiovascular patients are diagnosed in an ambulatory setting at any time and any place. Its breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software capable of assisting a physician in diagnosing a wide range of cardiovascular disease. HeartBeam is initially focusing on a huge unmet need of helping diagnose heart attacks in patients outside of a medical institution. No single lead ECG technology can offer this value to patients and their physicians. This underserved market is several times larger than the cardiac arrhythmia detection market based on the prevalence of patients with coronary artery disease at high risk of heart attack.

Spotlight

Serverless architecture is one of the latest trends in healthcare software development. It is a new way to design, architect and deploy cloud-based applications.

Spotlight

Serverless architecture is one of the latest trends in healthcare software development. It is a new way to design, architect and deploy cloud-based applications.

Related News

HEALTH TECHNOLOGY, FUTURE OF HEALTHCARE

Compulink Receives 21st Century Cures Act Certification From ONC

Compulink Healthcare Solutions | January 03, 2023

As the market leader in specialty-specific, all-in-one EHR solutions, Compulink Healthcare Solutions has earned the ONC-Health IT 2015 Edition Cures Update Health IT certification that will come into effect in 2023. This includes the most recent interoperability standards essential for supporting compliance with the information-sharing requirements of the 21st Century Cures Act. Compulink said that getting certified early shows how committed they are to making sure that their clients' solutions are in line with the many rules that require the use of certified EHR technology. Compulink Advantage™ is an all-in-one database EHR solution that provides its clients with practice management, inventory management, patient portal, mobile patient engagement, ASC, E-Commerce, analytics, optical POS (for eyecare practices), and a billing (RCM) service option. The company offers complete EHR solutions for ophthalmology, optometry, orthopedics, otolaryngology, behavioral health, dermatology, gastroenterology, podiatry, pain management, physical therapy, audiology, and urology. Drummond Group LLC, an authorized certification body, certified Compulink's EHR products (ACB). Drummond, testing for more than 20 years, has done more than 3,000 tests and certifications for health IT since 2010. About the Certification Compulink Advantage Version 12 complies with the 2015 Edition. It has been approved as such by an ONC-ACB based on the criteria for certification set by the Secretary of Health and Human Services. This certification does not mean that the United States Department of Health and Human Services backs the product or service in question. About theCompulink Healthcare Solutions Compulink Healthcare Solutions all-in-one EHR and practice management solution has helped specialty medical practices reduce costs, increase efficiency, and simplify the delivery of excellent patient care. Compulink is the leader in fully customizable EHR solutions that adapt to your practice style and is used by over 26,000 providers in over 4,700 locations, 70 ambulatory surgical centers, and 19 colleges and universities.

Read More

FUTURE OF HEALTHCARE

CareView Communications Executes Agreement with New Hospital in Pensacola, FL

CareView Communications, Inc. | November 17, 2022

CareView Communications, Inc. an information technology provider to the healthcare industry, announced the signing of an agreement with a health system building a new campus in Pensacola, FL. The new campus includes a new acute care hospital and behavioral health unit with room for future expansion. The agreement calls for the installation of the CareView Patient Safety System®, which facilitates continuous remote patient monitoring for patients who may be at risk of harm due to falls, behavioral issues, or suicidal ideation. The CareView solution leverages an in-room camera with audio capabilities and patented Virtual Bed Rails® and Virtual Chair Rails® technologies to improve patient safety. The Virtual Rails use machine learning to identify when the patient's movement indicates a fall may be imminent, and subsequently alerts the Safety Technician. Pre-recorded messages or 2-way audio allow for direct communication with the patient. The System offers a considerable impact on sitter reduction and overall patient safety. “We are pleased to be working with our newest partner and know that our System is the solution to address their needs to reduce patient falls and increase patient safety.” Sandra McRee, CareView’s Chief Operating Officer About CareView Communications, Inc. As a leader in turnkey patient video monitoring solutions, CareView is redefining the standard of patient safety in hospitals and healthcare facilities across the country. For over a decade, CareView has relentlessly pursued innovative ways to increase patient protection, providing next-generation solutions that lower operational costs and foster a culture of safety among patients, staff, and hospital leadership. With installations in more than 150 hospitals, CareView has proven that its innovative technology is creating a culture of patient safety where patient falls have decreased by 80% with sitter costs reduced by more than 65%. Anchored by the CareView Patient Safety System, this modular, scalable solution delivers flexible configurations to fit any facility while significantly increasing patient safety and operational savings. All configurations feature HD cameras, high-fidelity 2-way audio/video, LCD displays for the ultimate in capability, flexibility, and affordability. Corporate offices are located at 405 State Highway 121 Bypass, Suite B-240, Lewisville, TX 75067.

Read More

FUTURE OF HEALTHCARE, DIGITAL HEALTHCARE

Medisafe Launches New SaMD Technology to Enhance Business Solutions

Medisafe | January 05, 2023

Medisafe, a digital therapeutics firm focused on medication engagement, recently introduced SaMD technology. This announcement comes months after receiving ISO 13485:2016 accreditation for medical devices and ISO 27001:2013 certification for pharmaceutical and digital health platforms. These international registrations demonstrate Medisafe's clinical management and patient engagement leadership. With the market for disease management software growing, Medisafe's development shows that the company is committed to following the law, going above and beyond what is expected, and being at the forefront of SaMD development. The achievements made by Medisafe in the past year to better serve patients, doctors, and pharma partners have earned the company a great deal of pride. Medisafe remarked that the most recent announcement of registering as a SaMD is not only a crucial step in the company's development, but it is also essential that it anticipate and address changing customer and industry needs, both regulated and unregulated, as leaders and innovators in digital therapeutics. Medisafe continues to focus on non-regulated business-building solutions that exceed the needs of pharma, HUBs, providers, and patients. Through an interoperable, individualized, and patient-centric approach to digital patient connectivity, Medisafe's end-to-end Care Connector platform enables organizations to effectively engage with patients throughout the medication journey, supporting pharma's vision for a more digitally enhanced future. More than 10 million registrants utilize and rely on Medisafe's platform and digital drug companion to manage their medications, validating the value it brings to patients. Meanwhile, Medisafe will attend the 41st Annual J.P. Morgan Healthcare Conference, which will take place on January 9–12, 2023, in San Francisco, CA, USA. About Medisafe Medisafe® is a premier personalized medication management platform that connects users to their families (and soon, their doctors) for support, encouragement, and expertise to provide customized notifications for visits and refills, prescription updates, personalized health advice, and discounts. It monitors blood pressure and glucose to show the benefits of taking drugs as prescribed. The company improves patient happiness and care by preventing inaccurate or missed dosages.

Read More