HEALTH TECHNOLOGY

HeartBeam Announces FDA Submission of HeartBeam AIMI™ Product

HeartBeam, Inc. | August 17, 2022 | Read time : 02:00 min

HeartBeam Announces

HeartBeam, Inc. a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection,  announced it has submitted a 510(k) application to the US Food and Drug Administration for its HeartBeam AIMI™ platform technology for use in diagnosing heart attacks.

The 510(k) submission of our first product, based on our platform technology, is an important milestone toward commercialization and underscores our continued progress toward making the HeartBeam AIMI platform widely available to help Emergency Department physicians correctly and expeditiously diagnose patients with chest pain or other symptoms of a heart attack. I am proud of the HeartBeam team for their commitment to achieving this critical step in bringing the Company’s technology to market. We look forward to working through the FDA review process toward our goal of clearance for the US market.”

Branislav Vajdic, PhD, HeartBeam CEO and founder

The HeartBeam AIMI platform technology is anticipated to assist health care professionals 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. The goal of HeartBeam’s technology is to offer more accurate heart attack detection to triage patients and expedite treatment.

HeartBeam AIMI is software as a medical device with a 510(K) regulatory pathway. The HeartBeam algorithm used in an emergency department setting slots into existing physician workflow, leverages existing 12-lead ECG hardware and provides the attending physician with an instant comparison of the patient’s baseline and symptomatic ECG for their consideration in the patient’s diagnosis. This will allow physicians to quickly determine if a patient needs intervention or can be discharged which helps manage patient flow.

Jon Hunt, PhD, HeartBeam Executive Vice President and Chief Business Officer, added, “Our FDA approval process doesn’t require any human or animal trials, so there is good reason to believe that we will receive FDA clearance for a limited market release by end of 2022 and full commercial roll-out in Q1 2023. While the FDA conducts its regulatory review, our team will focus on executing key components of its commercialization plan and subscription revenue model. We continue to engage in positive discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize our products. We look forward to approval and offering our HeartBeam AIMI platform in an expected $500 million total addressable market.”

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

Centene is a leading healthcare enterprise committed transforming the health of the community, one person at a time. The company offers high-quality, affordable health insurance coverage to nearly 1 in 15 individuals across the nation.

Spotlight

Centene is a leading healthcare enterprise committed transforming the health of the community, one person at a time. The company offers high-quality, affordable health insurance coverage to nearly 1 in 15 individuals across the nation.

Related News

DIGITAL HEALTHCARE, MEDICAL DEVICES

Sofwave Medical Announces FDA Clearance of SUPERB™ Technology For Cellulite

SofWave Medical, Ltd. | December 20, 2022

Sofwave Medical Ltd an emerging leader in energy-based non-invasive, aesthetic medical devices announced the U.S. Food and Drug Administration’s clearance of Sofwave’s SUPERB™ technology to be used for the short-term improvement in the appearance of cellulite. Dr. Shimon Eckhouse, Chairman & Co-Founder commented on the occasion, “We are pleased to receive FDA clearance to use the Company's proprietary SUPERB™ technology to improve the appearance of cellulite in the short term. Non-invasive treatment of cellulite is one of the most desired body treatments in medical aesthetics because of the high prevalence of cellulite in women of all ages and the lack of effective and safe solutions with no patient down-time. Sofwave has shown once again that its investment in the development of the SUPERB™ technology to treat highly prevalent aesthetic indications bears significant fruit and will support the continued rapid growth of the Company. Our disruptive SUPERB™ technology was designed to be efficient and easy to use, and the Company invests and plans to continue investing in bringing innovative solutions to the growing aesthetic technology market generating great ROI to our physician customers.” In the clinical trials submitted to the FDA as part of the 510(k) application in support of the cellulite FDA clearance, the Company conducted a multi-site clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic improvement in cellulite appearance. A total of 68 women were treated at 4 sites in the United States. Eligible patients received 2 treatments using SUPERB™ technology on one side (right or left) of the lateral / posterior upper thigh or buttocks. Serial clinical photographs were collected under standardized conditions before treatment and at the 3-month follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). Improvement was also evaluated using the Global Aesthetic Improvement Scale (GAIS) and Laxity Scale (LS). Safety assessments included evaluation of adverse events via physician examination during and after the treatment. Post-study, the blinded reviewers correctly identified the post treatment images for 89% of the subjects. No serious or unanticipated adverse event was reported during the study. “The FDA's clearance of SUPERB™ for use in cellulite could not have come at a timelier moment. Our dedicated U.S. direct sales force is positioned to expand our growing presence and market share of the aesthetic medical device market in the U.S. In addition, our recent regulatory clearance in Brazil further extends our global footprint, letting us immediately launch sales in this important and sizeable market. Furthermore, our partnership in China with HTDK, one of Asia's strongest healthcare solutions providers, covers our expansion in that territory. Our focused commitment across these major markets, will go a long way towards further accelerating global sales and brand-recognition of our devices in the upcoming new year.” Lou Scafuri, Sofwave's CEO In 2021, the FDA cleared additional indications for SUPERB™ technology, for lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental neck regions. In addition, the Sofwave SUPERB™ technology is also cleared by the U.S. FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles. About SUPERB™ Sofwave’s state-of-the-art SUPERB™ Technology addresses the growing demand for non-invasive treatments that deliver noticeable results in non-invasive treatment of highly desired aesthetic indications. The device’s cooled transducers are directly coupled to the epidermis, creating a unique 3D array of volumetric thermal zones that deliver parallel energy simultaneously, heating precisely at the right depth in the mid-dermis. A single Sofwave treatment reduces facial wrinkles in a fast 30 to 45 minute non-invasive treatment with no interruption to a patient’s daily routine or post-treatment discomfort. About Sofwave Medical Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction lifting and cellulite using proprietary breakthrough technology. SUPERB™, Synchronous Ultrasound Parallel Beam technology is FDA-cleared to improve facial lines and wrinkles, lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue and the short term improvement in the appearance of cellulite providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients.

Read More

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

HEALTHTECH SECURITY, DIGITAL HEALTHCARE

CHA Hollywood Presbyterian Medical Center Launches Fetal Surgery Program

CHA Hollywood Presbyterian Medical Center | January 23, 2023

Hollywood Presbyterian Medical Center (CHA HPMC), a member of CHA Health Systems, recently announced a new partnership with Los Angeles Fetal Surgery to provide life-saving and revolutionary fetal surgery to pregnant women and their unborn babies with birth defects. It will be the only fetal surgery center in the U.S. Los Angeles Fetal Surgery, a joint program between USC and Children's Hospital Los Angeles, offers minimally invasive fetal treatments to reduce or cure adverse outcomes due to fatal conditions, which would otherwise result in the baby's death or irreversible organ damage. Dr. Ramen Chmait, an international expert in minimally invasive fetal surgery, will direct the program. He has produced over 200 manuscripts and book chapters in fetal medicine and surgery over the past 20 years. "The goal of the Los Angeles Fetal Surgery Program at CHA Hollywood Presbyterian is to treat unborn babies with innovative treatments while providing families with emotional support," said Ramen Chmait, MD, who also serves as an OB-GYN with Keck Medicine of USC. (Source- Business Wire) "Our collaborative structure ensures our patients have access to a wide variety of services and specialists. This affiliation with CHA HPMC only strengthens our commitment to successful outcomes,” he further added. (Source- Business Wire) According to the CDC, 1 in 33 U.S. newborns is born with a serious condition. The program will treat Spina Bifida, Vasa Previa, and Twin-Twin Transfusion Syndrome. CHA HPMC, Los Angeles' second-largest maternity center, provides excellent prenatal and postpartum care. Fetal surgery will help CHA HPMC serve its community and improve results for expectant families. About CHA Hollywood Presbyterian Medical Center CHA Hollywood Presbyterian Medical Center (CHA HPMC) is a full-service hospital, providing acute care to the multicultural population of Hollywood and its neighboring regions since 1924. CHA Bio Group is known worldwide for its high-quality health care and advances in reproductive medicine. CHA HPMC has 469 acute care beds and 89 skilled nursing beds. The hospital employs about 550 doctors from 69 disciplines and 75 nationalities. It treats its various multicultural patients with kindness and compassion. CHA Health Systems, a dynamic global healthcare corporation with 86 hospitals and clinics, 30 research and 14 education institutes, along with 31 bio/pharmaceutical/healthcare enterprises, provides a wide range of services in seven countries.

Read More