Cardiac Monitors in New Jersey

Avertix Medical Inc. manufactures Guardian, the FDA-approved implantable cardiac alert system designed for early detection of acute coronary occlusion and myocardial infarction. Guardian is the world's first and only heart attack warning system approved by the FDA and represents a breakthrough device filling an unmet medical need in post-infarction patient management. The Guardian system provides continuous 24/7 monitoring and detection of abnormal changes in cardiac activity, including silent myocardial infarctions that would otherwise go undetected by symptom-based assessment. Upon detection of coronary occlusion onset, the device delivers real-time alerts to the patient through an emergency alarm comprising loud beeping, red flashing light, and chest vibration, prompting immediate emergency care activation. Key clinical benefits supported by peer-reviewed research include significant reduction in pre-hospital delay—Guardian patients arrived at the emergency department an average of 6.3 hours earlier than those relying on symptoms alone in the ALERTS study. This accelerated care is critical because approximately 45% of myocardial infarctions are silent or asymptomatic, and patients with prior myocardial infarction face a 20% elevated risk of recurrent events within five years, with substantially higher risk in diabetic, smoking, or multi-vessel coronary disease populations. The device targets secondary prevention in high-risk populations with prior myocardial infarction history and provides continuous peace of mind through automated detection, addressing the significant clinical and psychological burden associated with fear of unrecognized recurrent cardiac events. Clinical data demonstrate meaningful reduction in myocardial damage and improved outcomes through rapid intervention enabled by early warning detection.

Caregility Corporation is an enterprise telehealth and virtual care platform provider serving healthcare systems, hospitals, and care facilities across inpatient, outpatient, and home settings. Founded in 2011, the company delivers the Caregility Connected Care™ Platform, a cloud-based ecosystem that integrates AI-powered clinical workflows, virtual nursing, bedside sensors, and secure video collaboration tools. The platform enables virtual care delivery across emergency departments, ICUs, operating rooms, observation units, behavioral health, neonatal care, and long-term care environments. With deployments in over 1,100 hospitals across 85+ health systems, Caregility facilitates more than 6 million virtual sessions annually. The platform addresses critical healthcare challenges including clinician shortages, geographic access barriers, and operational inefficiency through features such as real-time clinical collaboration, remote patient monitoring, automated workflow support, and integrated analytics. Caregility emphasizes 99.99% platform availability, HIPAA compliance, ISO 27001/27701 certification, and 24/7 expert support, positioning itself as a mission-critical infrastructure provider for hospital networks seeking to scale virtual care at enterprise scale.

Clario (formerly Bioclinica) is a global clinical trial endpoint technology platform and services provider with 50+ years of expertise supporting drug development. The company delivers comprehensive solutions for efficacy, safety, and patient quality-of-life assessments across decentralized, hybrid, and site-based clinical trials in over 100 countries. Clario's integrated platform combines clinical trial management software, connected medical devices, and AI-powered solutions spanning cardiac safety monitoring, electronic clinical outcomes assessment (eCOA), medical imaging with imaging core lab services, precision motion analysis, and respiratory endpoints. With experience managing 30,000+ trials contributing to 700+ FDA/EMA new drug approvals, Clario employs 3,900+ professionals including 200+ therapeutic area specialists. The platform emphasizes regulatory compliance, patient-centric design, global multilingual deployment, and 24/7 operational support to simplify trial processes for sponsors, contract research organizations (CROs), and research sites.

iMedrix Diagnostics Corp. is a medical device company headquartered in Northern New Jersey specializing in mobile cardiac care solutions. The company develops and markets KardioScreen™, a US FDA 510(k)-cleared, medical-grade mobile 12/6-lead ECG system that enables real-time cardiac monitoring and diagnosis. KardioScreen™ is cloud-connected, fully digital, and designed for bedside and remote monitoring applications, allowing clinicians to diagnose and manage cardiac conditions within minutes. The platform serves hospitals, clinics, and care providers seeking portable, economical alternatives to traditional fixed ECG systems. iMedrix targets both acute care settings and remote/home-based monitoring environments. The company emphasizes patient-centric design, regulatory compliance (FDA 510(k) clearance), and accessibility of cardiac diagnostics through innovative digital technology.

Impulse Dynamics USA Inc manufactures the Optimizer® Smart Mini system, a minimally invasive implantable cardiac device that delivers Cardiac Contractility Modulation (CCM®) therapy for patients with moderate to severe chronic heart failure. The device is indicated for NYHA Class III heart failure patients with LVEF 25–45% who remain symptomatic despite guideline-directed medical therapy and are not candidates for cardiac resynchronization therapy (CRT). The Optimizer® Smart Mini senses cardiac electrical activity and delivers precisely timed, non-excitatory electrical pulses throughout the day to improve functional capacity, exercise tolerance, quality of life, and 6-minute walk distance. The system has no pacemaker or ICD functions. As of the company's reporting, the device has been implanted in over 9,000 patients. Medicare National Coverage Determination (NCD) was issued for CCM® therapy, covering all FDA-indicated patients age 18 and older who have not undergone heart transplant. The company provides physician finder and patient education resources to support treatment access. Impulse Dynamics serves the global heart failure market, targeting the growing patient population (64+ million adults worldwide; 5.7 million in the US, projected to exceed 8 million by 2030).

Soterix Medical is the global leader in non-invasive neuromodulation and integrated brain monitoring technology. The company designs, manufactures, and markets advanced research and clinical-grade systems for transcranial electrical stimulation (tDCS, tES, HD-tES), transcranial magnetic stimulation (TMS, MEGA-TMS), transcranial focused ultrasound stimulation (tFUS), and related modalities. Research platforms include 1x1 tDCS/tES systems, high-definition HD-tES platforms, temporal interference stimulation (TI), taVNS (transcutaneous auricular vagus nerve stimulation), galvanic vestibular stimulation, and fully integrated multimodal solutions combining stimulation with EEG, fMRI, PET, and fNIRS. Clinical systems target depression (tDCS-LTE), pain conditions (PainX tDCS and TENS), and major depressive disorder (SPRY TMS). The company also offers neurotargeting software (HD-Explore, HD-Targets, tDCS-Explore), mobile EEG systems, and animal pre-clinical stimulation systems. Soterix holds FDA 510(k) clearances for multiple products including Depression tDCS-LTE, SPRY TMS, IontoDC, MEGA-IOM intraoperative neuromonitoring, and Neural Navigator TMS neuronavigation. CE Mark approvals exist for 1x1 tDCS depression and PainX pain treatment. The company serves academic research centers, clinical institutions, and specialized neurology and psychiatry practices worldwide. Manufacturing and quality standards reflect commitment to precision, usability, and regulatory compliance across research and clinical applications.

NeuroMetrix, Inc. is a neurotechnology company specializing in non-invasive medical devices for diagnosing and treating pain and neurological disorders. The company develops point-of-care neuropathy diagnostic tests and FDA-approved wearable neurostimulation devices. Its Quell® platform is a wearable neuromodulator designed for chronic pain management and fibromyalgia symptom reduction. DPNCheck provides rapid nerve conduction testing for peripheral neuropathy evaluation. NeuroMetrix targets healthcare professionals including endocrinologists and podiatrists, as well as direct consumers. Founded in 1996 and based in Woburn, Massachusetts, the company is a wholly-owned subsidiary of electroCore, Inc. and is publicly traded on Nasdaq (NURO). The company emphasizes innovation in digital medicine and neurostimulation through clinical feedback and research.

Princeton BioMeditech Corporation (PBM) is a world leader in rapid, point-of-care diagnostic products. The company manufactures and distributes an extensive portfolio of over 70 different one-step rapid diagnostic tests utilizing patented immunoassay technologies. PBM serves both consumer in-home and professional on-site/point-of-care markets with FDA-cleared and ISO 13485:2016 certified products. Product lines include rapid antigen detection tests for COVID-19/Flu, cardiac markers, infectious disease diagnostics, fertility testing, drugs of abuse screening, tumor markers, and food/environmental pathogen detection. The company offers OEM services, point-of-care analyzer systems, research and development capabilities, and comprehensive product support. Based in Princeton, New Jersey, PBM maintains USA manufacturing operations and serves healthcare providers, clinical laboratories, and consumers globally.

VectraCor designs and manufactures portable diagnostic medical devices that enable primary care, urgent care, and telemedicine environments to perform cardiac and pulmonary testing. The company specializes in ECG systems, Holter monitoring, and spirometry platforms that integrate with standard tablets and laptops, reducing infrastructure costs while maintaining clinical-grade diagnostics. The VectraplexECG system uses patented 5-electrode technology to derive 15–22 lead ECG traces and detect changes suggestive of acute coronary events via the proprietary Cardiac Electrical Biomarker (CEB®). The V300 Holter monitor provides continuous ambulatory cardiac monitoring with cloud-based data transfer and EMR integration. The Orbit™ Spirometer delivers pulmonary function testing with mobile deployment. All devices are FDA-cleared, CE-marked, and manufactured under ISO 13485 certification. VectraCor products emphasize durable, portable design for point-of-care diagnostics and remote monitoring workflows, with integrated EMR connectivity to major health systems and email-based report distribution.