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Patient Monitoring Equipment Manufacturers

Last updated: February 2026

This directory lists 76 patient monitoring equipment manufacturers across the United States, from specialized vital signs module developers to full-stack telemetry system providers.

Buyers are often solving for enhanced patient safety, improving clinical workflow efficiency, or enabling remote care models. This demands manufacturers capable of integrating advanced physiological parameter algorithms, ensuring robust electromagnetic compatibility (EMC) in diverse clinical environments, and developing user interfaces optimized for human factors engineering (HFE).

Suppliers range from original design manufacturers (ODMs) specializing in specific components like pulse oximetry sensors or capnography modules, to full-service contract manufacturers handling everything from design control to final assembly and regulatory submission for complete bedside monitors or ambulatory monitoring devices. Some focus solely on disposable accessories or integrated software solutions.

Buyers should come prepared with detailed clinical requirements, target patient populations, desired regulatory clearances (e.g., FDA 510(k), CE Mark), and specific data integration needs, including preferred communication protocols like HL7 or FHIR for electronic health record (EHR) interoperability.

A significant trend is the shift towards connected health and remote patient monitoring (RPM), driving demand for manufacturers with expertise in secure wireless communication, cloud-based data platforms, and robust cybersecurity frameworks that comply with evolving data privacy regulations.

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Company Directory

76 companies nationwide

American Diagnostic Corporation

American Diagnostic Corporation (ADC) manufactures diagnostic instruments and medical devices for healthcare professionals and institutions. Specializing in stethoscopes, digital blood pressure monitors, and thermometry, ADC has provided high-quality equipment for 40 years. Their products are designed for exceptional performance and durability.

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AliveCor

AliveCor develops and manufactures AI-enabled, machine learning-powered ECG sensors that deliver medical-grade heart data. The company offers innovative products like the Kardia 12L, a portable 12-lead ECG device designed for healthcare professional use. AliveCor's doctor-recommended personal ECG devices support millions of users globally.

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Ambulatory Monitoring, Inc.

Ardsley, NY

Based in Ardsley, NY, Ambulatory Monitoring, Inc. is an FDA registered medical device manufacturer. The company provides unique instruments for long-term physiological and environmental monitoring, documenting sleep, activity levels, fatigue, circadian rhythm, and respiration in ambulatory subjects for research and clinical use.

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Ambu Inc.

Ambu Inc. develops and manufactures single-use medical devices, including endoscopy, anesthesia, and patient monitoring & diagnostics products. Headquartered in Columbia, MD, the company provides essential solutions for healthcare professionals in hospitals and critical care environments. Their product range supports improved patient care and operational efficiency.

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Ascensia Diabetes Care

Parsippany, NJ

Ascensia Diabetes Care is a global company dedicated to manufacturing blood glucose monitoring systems. Based in Parsippany, NJ, the company provides the CONTOUR® portfolio of devices specifically designed for individuals managing diabetes. They focus on improving health through their range of patient monitoring equipment.

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Baxter

Baxter is a global medical technology company manufacturing essential medical devices. They offer connected solutions for healthcare delivery in hospitals and care sites, including patient monitoring equipment like the Welch Allyn Connex Spot Monitor for accurate vital signs measurements, aiming to deliver smarter, personalized patient care.

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Bentec Medical

Santa Barbara, CA

Bentec Medical specializes in custom silicone fabrication and OEM contract manufacturing for medical devices. The company also designs, manufactures, and distributes proprietary FDA and CE approved silicone medical devices under its own label. These devices serve various fields including oncology, cardiology, urology, and pediatrics.

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Bionet America

Bionet America manufactures medical and veterinary technology and equipment, including fetal monitors. The company offers easy-to-use, reliable, and safe devices designed to provide quality patient care in healthcare settings.

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Biotricity

Redwood City, CA

Based in Redwood City, CA, Biotricity develops advanced cardiac monitoring systems and remote health monitoring solutions. The company empowers healthcare providers and individuals with clinically superior heart data for early diagnosis, personalized treatment plans, and proactive care, supporting chronic care management.

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Bruin Biometrics

Los Angeles, CA

Bruin Biometrics manufactures biometric sensor technology for early risk assessment, monitoring, and prevention of chronic conditions. They are world leaders in pressure injury prevention, inventing sub-epidermal moisture (SEM) assessment device technology. The company focuses on digital solutions for preventable conditions in healthcare.

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Cadwell Industries Inc.

Cadwell Industries Inc. engineers and innovates neurodiagnostic, neuromonitoring, and sleep diagnostic neurology equipment. The company provides solutions for EEG brain monitoring, EMG, EP, NCS, Ultrasound, IONM surgical monitoring, PSG, and HSAT sleep diagnostics, focusing on intuitive usability and quality.

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Cirtronics

Milford, NH

Based in Milford, NH, Cirtronics is a contract manufacturer specializing in high-reliability, complex medical devices. The company manufactures Class II devices, including imaging systems, surgical equipment, and medical robotics, serving the patient monitoring equipment industry with precision manufacturing.

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CMI Health

Alpharetta, GA

Based in Alpharetta, GA, CMI Health manufactures innovative patient monitoring devices, including pulse oximeters, smart spirometers, and vital sign monitors. They provide accurate measurements to track vital signs and manage health effectively. Their offerings also include secure cloud-based software solutions, empowering both medical professionals and home users with proactive healthcare management.

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Dexcom

San Diego, CA

Based in San Diego, CA, Dexcom manufactures continuous glucose monitoring (CGM) systems. The company specializes in biosensing technology, providing devices that deliver accurate, real-time glucose readings. Their innovative solutions empower individuals to simplify diabetes management and proactively control their overall health.

Email availablePhone available

Edan USA

Edan USA provides quality diagnostic medical equipment, specializing in patient monitoring solutions for healthcare facilities. Their product range includes advanced patient monitors like the Edan X10 with WiFi and CO2 options, as well as fetal and maternal monitors, EKG machines, and vital sign monitors.

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Eversense

Eversense manufactures the Eversense 365 Continuous Glucose Monitoring (CGM) system, offering individuals taking insulin a year-long implantable sensor that provides real-time glucose readings. This medical device aims to minimize frustrations associated with traditional short-term CGMs.

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GE HealthCare

GE HealthCare manufactures patient monitoring equipment and associated supplies, specializing in precision care for hospitals. The company delivers innovative, patient-focused technologies, including ECG, cardiac-output, invasive-pressure, and temperature monitoring systems. These integrated solutions enhance clinical efficiency, optimize therapies, and improve overall patient health.

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Philips Ambulatory Monitoring and Diagnostics

Based in Malvern, PA, Philips Ambulatory Monitoring and Diagnostics provides smart, comprehensive, and connected patient monitoring and diagnostic solutions. They enable healthcare providers to transform workflows, proactively manage patient populations, and deliver care across the continuum, from home to hospital.

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HDA Technology

Forest, CA

HDA Technology creates and builds medical devices for clients across the country. Specializing in custom medical device manufacturing, the company develops sophisticated equipment for the healthcare industry. Their expertise includes various medical technology solutions, pertinent to patient monitoring systems and diagnostics.

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Hi-Tech Medical Products

Buena Park, CA

Based in Buena Park, CA, Hi-Tech Medical Products manufactures medical devices, including diagnostic equipment and wearable sensor technologies for patient monitoring. They offer precision die cutting for complex components, catheter securement, and diabetes CGM/insulin delivery solutions. The company is ISO 13485:2016 Certified.

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Hillrom

Chicago, IL

Based in Chicago, IL, Hillrom manufactures advanced patient monitoring equipment, including Welch Allyn's Connex Vital Signs Monitors. These wireless solutions offer EMR connectivity for real-time patient data, supporting healthcare in various settings like hospitals, physician's offices, and home care.

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ICU Medical

San Clemente, CA

ICU Medical manufactures life-saving and enhancing medical devices, offering innovative patient care solutions. Their product portfolio includes infusion therapy, pharmacy preparation, and airway management tools designed to capture vital signs. The company focuses on simplifying complexity, streamlining workflows, and reducing risks for clinicians and caregivers.

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ZOLL Itamar

Based in Bedford, MA, ZOLL Itamar manufactures patient monitoring equipment. They produce innovative diagnostic devices, like the FDA-cleared WatchPAT line, for home sleep apnea and cardiovascular condition detection. The company provides advanced testing solutions for healthcare providers and patients.

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Kent Scientific

Torrington, CT

Kent Scientific, based in Torrington, CT, specializes in manufacturing non-invasive blood pressure and physiological monitoring equipment. The company provides a range of products including CODA monitors, cuffs, and accessories for patient monitoring. They also offer anesthesia systems and related accessories for scientific and medical applications.

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LifeSignals

LifeSignals manufactures scalable patient monitoring solutions, including multi-parameter biosensors for ECG and vital signs. Their UbiqVue systems offer robust, wireless, and disposable monitoring for hospitals and virtual wards, delivering near real-time biodata. The company also provides cloud-based Holter ECG monitoring and analysis.

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LucidAct Health Inc.

Santa Clara, CA

Based in Santa Clara, CA, LucidAct Health Inc. offers a SMART REmote Care platform featuring FDA-approved smart medical devices for patient monitoring. The company specializes in remote patient monitoring management, chronic care management, and integrated tele-health solutions, providing real-time data syncing and personalized alerts.

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MGC Diagnostics

Saint Paul, MN

Based in Saint Paul, MN, MGC Diagnostics manufactures non-invasive diagnostic systems for cardiorespiratory disease. They provide equipment for pulmonary function testing, metabolic analysis, and stress ECG. The company also offers remote patient monitoring solutions to detect and manage cardiorespiratory conditions.

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Nasiff Associates, Inc.

Based in New York, NY, Nasiff Associates, Inc. is a medical device manufacturer specializing in PC ECG devices. The company proudly produces all its patient monitoring equipment within the United States, ensuring high quality and precision in its products for healthcare providers.

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Natus Medical Incorporated

Wayzata, MN

Natus Medical Incorporated, based in Wayzata, MN, designs and manufactures innovative equipment for screening, diagnosing, and treating neurological and sensory disorders. The company focuses on simplifying care and research for complex bodily systems, providing solutions that empower healthcare professionals to deliver exceptional patient care.

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NeuroSky

San Jose, CA

Based in San Jose, CA, NeuroSky manufactures advanced EEG and ECG biosensors, developing versatile brainwave headsets for health, education, and entertainment applications. They provide single-lead EEG sensors delivering real-time brainwave data for brain-computer interfaces and OEM applications, supporting biometric and brainwave innovation for partners.

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Neurovision Medical Products

Ventura, CA

Neurovision Medical Products, based in Ventura, CA, specializes in manufacturing advanced intraoperative neuromonitoring (IONM) systems. Their Nerveäna Plus system provides comprehensive EMG nerve monitoring for various surgical procedures, enhancing patient safety and outcomes. The company focuses on critical nerve integrity assessment medical devices.

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Newman Medical

Arvada, CO

Based in Arvada, CO, Newman Medical designs and manufactures professional fetal and vascular Dopplers. They specialize in simpleABI ankle brachial index test systems for PAD diagnosis and DigiDop arterial Dopplers for reliable blood flow detection, serving healthcare professionals.

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Nonin Medical

Nonin Medical designs and manufactures noninvasive patient monitoring equipment, including pulse oximeters, regional oximeters, and sensors. They provide the cloud-based Nonin Health® platform for remote oximetry data and the FDA-cleared TruO2® OTC fingertip oximeter, focusing on equitable and accurate readings.

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PyrAmes Health

Cupertino, CA

Based in Cupertino, CA, PyrAmes Health develops accurate, non-invasive, continuous, and wireless blood pressure monitoring equipment. Their solutions cater to patients of all ages, from newborns to seniors, with a focus on neonatal and pediatric applications. These devices support diagnostics, treatment validation, and home medical management.

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QT Medical, Inc.

Diamond Bar, CA

QT Medical, Inc. manufactures innovative 12-lead resting ECG systems, featuring the PCA 500 recorder and QHeart single-use sensors. Their solutions streamline cardiac care with simplified lead placement, improved accuracy, and HIPAA-compliant cloud management. They serve professional remote care, EMS, urgent care, clinics, and home monitoring settings.

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Sanmina Corporation

San Jose, CA

Sanmina Corporation designs and manufactures advanced medical devices, including ultrasound systems, CT, MR, nuclear medicine systems, X-Ray systems, and patient monitors. Based in San Jose, CA, the company provides comprehensive manufacturing solutions for a range of technology and medical industries.

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SNS BIOSYSTEMS

Santa Maria, CA

Based in Santa Maria, CA, SNS BIOSYSTEMS is an FDA and California FDA registered facility. The company is qualified to manufacture, sell, and service the SNS Biosensor™, providing comprehensive manufacturing services for patient monitoring equipment. They ensure product validation and compliance with stringent regulatory standards for medical devices.

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Sonic Manufacturing

Fremont, CA

Based in Fremont, CA, Sonic Manufacturing provides customized production solutions and electronics manufacturing services. They specialize in IoT and wearable devices, offering PCB assembly and system integration. Sonic is a direct provider for companies manufacturing patient monitoring equipment and other high-tech medical wearables.

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SunTech Medical, Inc.

Morrisville, NC

Based in Morrisville, NC, SunTech Medical, Inc. specializes in designing and manufacturing advanced blood pressure clinical monitoring and OEM non-invasive blood pressure (NIBP) solutions. They provide accurate, portable devices for continuous monitoring in both medical and veterinary fields, including the SunTech Vet40 for animal patients, focusing on precision and quality in BP technology.

Email availablePhone available

Tenovi

Portsmouth, NH

Based in Portsmouth, NH, Tenovi manufactures FDA-cleared hardware devices for remote patient monitoring. The company provides a plug-and-play cellular gateway that simplifies remote care by enabling patients to take readings which are automatically sent to the cloud, facilitating remote health programs.

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Wearable Sensing

San Diego, CA

Wearable Sensing, based in San Diego, CA, specializes in manufacturing advanced dry EEG systems and hybrid EEG+fNIRS devices. These innovative solutions deliver research-grade signal quality, robustness to artifacts, and comfort for extended use. Their VR-compatible systems and neurovascular coupling technology provide practical and high-quality physiological monitoring equipment.

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Wesper

York, NY

Wesper manufactures FDA-cleared at-home sleep testing platforms and devices for diagnosing and managing sleep apnea. Their innovative technology delivers lab-grade data, including respiratory effort, SPO2, and heart rate, through a comfortable, flexible patch. Wesper focuses on clinical precision and multi-night insights for improved patient care.

Email availablePhone available

Zoe Medical, Inc.

Zoe Medical, Inc. based in Topsfield, MA, manufactures patient monitoring systems. Established in 1996, they design and build advanced solutions for diverse clinical environments, including oral surgery, EMS, physician offices, and central monitoring. The company leverages R&D to introduce innovative products, with thousands of units installed worldwide.

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ZOLL Medical

Spanish Fork, UT

ZOLL Medical specializes in manufacturing technologically advanced medical products and systems for patient monitoring and critical care. They offer solutions for sleep apnea diagnosis and treatment, including products like WatchPAT and the remedē System, supporting healthcare across the continuum of care.

Email availablePhone available

iHealth Labs

iHealth Labs manufactures FDA-authorized medical devices for personal and remote patient monitoring. Their product line includes wireless blood pressure monitors and smart glucose monitoring systems, designed for home and enterprise use.

Email available

inomed

San Bruno, CA

Based in San Bruno, CA, inomed provides advanced patient monitoring equipment. The company offers the ISIS IOM system family, a comprehensive package of products for multimodal intraoperative neurophysiological monitoring. They also develop ISIS Neurostimulators, supporting critical surgical procedures in healthcare settings.

Email available

Medtronic

Medtronic manufactures advanced medical devices, specializing in patient monitoring equipment. Their offerings include the BioButton, a medical-grade wearable providing trending data on key vital signs and biometrics, serving as an early indicator of patient decline.

Email available

Mindray

Mindray manufactures comprehensive patient monitoring equipment designed for various clinical environments. Their solutions offer advanced functionality and user-friendly displays. Mindray North America is expanding its strategic partnerships and infrastructure, providing quality healthcare products across the United States.

Email available

Nuvo Cares

Las Vegas, NV

Based in Las Vegas, NV, Nuvo Cares manufactures the FDA-cleared INVU platform for remote fetal monitoring. This system provides expectant mothers with a wearable device for self-administered nonstress tests at home. Clinicians access real-time data and integrate it into EMR, enhancing convenience and maternal care through innovative technology.

Email available

Profusa, Inc.

Garden City, NY

Based in Garden City, NY, Profusa, Inc. pioneers tissue-integrating biosensors for continuous monitoring of body chemistries. The company develops next-generation wireless devices, including the Lumee® Oxygen Platform, which is designed to enable telehealth and remote patient monitoring. Profusa's technology facilitates real-time, in-body chemical analysis.

Email available

Strados Labs

Strados Labs develops the RESP® platform, a medical-grade wearable respiratory monitor and stethoscope. This system captures high-fidelity lung sounds and coughs for continuous patient monitoring from hospital to home. It supports clinical trials, disease surveillance, and academic research.

Email available

Stryker

Weston, FL

Stryker is a prominent medical technology company manufacturing innovative products for healthcare professionals. They provide a diverse range of medical equipment, including surgical visualization and arthroscopic fluid management systems. Based in Weston, FL, the company's offerings are integral to supporting patient care and optimizing procedural outcomes in medical facilities.

Email available

TZ Medical

Tualatin, OR

Based in Tualatin, OR, TZ Medical designs and produces innovative medical devices for healthcare. They specialize in patient monitoring solutions, offering complete cardiac monitoring systems, defibrillation electrodes, and patient positioning products for clinical settings. TZ Medical also assists clients in bringing new medical device ideas to market.

Email available

Abbott

Chicago, IL

Based in Chicago, IL, Abbott manufactures advanced patient monitoring equipment for various medical conditions. The company specializes in developing continuous glucose monitoring (CGM) systems for diabetes management, providing critical health data. Abbott serves healthcare providers and patients globally with its directly manufactured medical devices.

Phone available

Advanced Brain Monitoring

Advanced Brain Monitoring is a neuro-diagnostics device company developing innovative technologies for patient monitoring. They manufacture products like Sleep Profiler and mobile EEG systems for clinicians and researchers. These devices interpret brain and physiological function to assess chronic diseases, neurodegeneration, and sleep quality.

Phone available

AMI Cardiac Monitoring

Based in Malvern, PA, AMI Cardiac Monitoring manufactures ambulatory cardiac monitoring systems. As an FDA-registered medical device manufacturer and ISO 13485:2016 certified, they produce trusted heart monitors. Their product range includes Holter, Cardiac Event, and Mobile Cardiac Telemetry (MCT) devices, supporting comprehensive patient cardiac assessment.

Phone available

CleveMed

Cleveland, OH

Based in Cleveland, OH, CleveMed manufactures home sleep testing solutions designed for sleep professionals. Their patient monitoring devices meet AASM guidelines, focusing on ease of use and cost-effectiveness. They provide professional-grade equipment for at-home diagnostic needs.

Phone available

Infinium Medical, Inc.

Largo, FL

Based in Largo, FL, Infinium Medical manufactures patient monitors and a variety of other medical technologies. The company operates from its USA – FDA registered – ISO 13485 2016 quality certified facilities, ensuring high standards in the production of equipment for healthcare providers.

Phone available

LogicMark

LogicMark provides medical alert devices and emergency response systems for senior living communities, caregivers, and healthcare providers. Their solutions feature easy-to-use devices with real-time monitoring and caregiver support tools, aiming to reduce fall risks and enhance patient safety. LogicMark is also a GSA-approved VA supplier.

Phone available

MediPines Corporation

Linda, CA

Based in Linda, CA, MediPines Corporation manufactures advanced, non-invasive patient monitoring equipment. Their AGM100® device precisely evaluates cardiorespiratory function and detects respiratory impairment severity. It provides accurate, actionable results in under two minutes, supporting early detection and management decisions in respiratory distress cases.

Phone available

Neteera

Lewes, DE

Neteera manufactures FDA-cleared Class II contactless patient monitoring systems, integrating real-time data into healthcare workflows. The Neteera System measures micro-movements to detect anomalies, aiding early prevention and improving patient outcomes. It serves post-acute care, senior living, and rehabilitation facilities with a passive, camera-free approach.

Phone available

OCP Group Inc

San Diego, CA

Based in San Diego, CA, OCP Group Inc develops reference assemblies with embedded sensors for wearable diagnostics. The company manufactures medical cables, alongside various industrial and transportation cable solutions. They serve manufacturers requiring specialized connectivity and sensor integration for patient monitoring equipment and critical applications.

Phone available

Senseonics

Based in Germantown, MD, Senseonics manufactures innovative patient monitoring equipment. They are creators of the first and only long-term implantable continuous glucose monitoring (CGM) system, the Eversense, which enhances glycemic control. The company focuses on the accuracy and safety of its advanced glucose monitoring solutions.

Phone available

Sotera Digital Health

Carlsbad, CA

Sotera Digital Health manufactures the ViSi Mobile Patient Monitoring System, offering continuous, cuff-less tracking of vital signs including BP, SpO2, ECG, and respiration. Based in Carlsbad, CA, the system uses machine learning to detect patient deterioration, streaming real-time data to EMRs for improved safety and workflow in general care settings.

Phone available

Vivalink, Inc.

Vivalink, Inc. develops clinically validated wearable sensors for patient monitoring, including ECG, temperature, SpO2, and BP monitors. These devices provide continuous cardiac monitoring and episodic data capture for digital health, hospital-at-home, and clinical research, ensuring consistent, compliant use.

Phone available

Boston Scientific Cardiac Diagnostics

Boston Scientific Cardiac Diagnostics manufactures remote patient monitoring equipment. Their BodyGuardian™ remote cardiac monitor is a comfortable, waterproof, wearable device designed for 24/7 use. It delivers powerful ECG data for physicians, aiding accurate diagnosis and allowing patients to collect essential cardiac information without disruption.

No contact on file

Huxley Medical, Inc.

Atlanta, GA

Based in Atlanta, GA, Huxley Medical, Inc. manufactures innovative patient monitoring equipment. They specialize in a bio-sensor enabled patch for simultaneous ECG and sleep apnea diagnostic testing, streamlining cardiosleep assessments. The company delivers reliable diagnostic data validated against gold standard PSG for modern, home-based medical care.

No contact on file

iRhythm Technologies

iRhythm Technologies specializes in advanced cardiac monitoring, providing the iRhythm® service featuring Zio® ECG monitors. They offer easy-to-wear, highly accurate devices for comprehensive heart rhythm detection. Their end-to-end service emphasizes patient compliance and precision care through innovative, discreet monitoring technology.

No contact on file

OMRON Healthcare

OMRON Healthcare manufactures advanced patient monitoring equipment, focusing on accurate and portable blood pressure monitors. Their devices automatically screen for AFib during routine checks, enhancing health monitoring without additional steps. The company is committed to delivering high-quality products that meet stringent clinical standards.

No contact on file

Sempulse

Sempulse manufactures the FDA-cleared Halo Vital Signs Monitor, a non-invasive device for continuous, real-time monitoring of vital signs including NIBP, SpO2, heart rate, and temperature. Its accompanying platform and app allow medical professionals to remotely manage hundreds of patients simultaneously, delivering automated alerts and detailed analyses.

No contact on file

Spacelabs Healthcare

Spacelabs Healthcare develops and manufactures advanced patient monitoring equipment and integrated solutions for healthcare systems. They provide superior measurement devices, clinical informatics, and operational strategies to enhance care team performance, including specialized fetal heart rate monitoring systems.

No contact on file

Sunrise

Sunrise manufactures a certified medical device for diagnosing sleep apnea. This patient monitoring equipment offers high clinical accuracy and an optimized patient experience, aiming to reduce costs for healthcare professionals. The company emphasizes truly simple, clinical, and accessible solutions for medical diagnostics.

No contact on file

Nihon Kohden America, LLC

New Orleans, LA

Nihon Kohden America, LLC provides precision medical solutions, specializing in interconnected technologies for patient monitoring, ventilation, and neurology. Their comprehensive product portfolio supports critical care, perioperative/surgical care, and sleep diagnostics across the healthcare continuum, alongside digital solutions and accessories.

No contact on file

Philips

Based in Cambridge, MA, Philips is a multinational technology company manufacturing advanced medical devices. They provide comprehensive patient monitoring equipment, enabling continuous virtual patient observation and enhanced care management across various hospital settings.

No contact on file

Viant

Viant is a medical device design and manufacturing partner for OEMs, specializing in complex medical devices. Serving various clinical markets, including interventional and inhalation devices, the company offers manufacturing capabilities to elevate product quality and performance within the MedTech industry.

No contact on file

Withings

Withings manufactures clinically validated smart health devices for patient monitoring, including easy-to-use blood pressure monitors. Their product range features advanced connected health stations like Body Scan, the BeamO family care device, and U-Scan, a toilet-embedded urine lab for home health tracking.

No contact on file

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How to Choose a Company

  • Verify the manufacturer's track record with FDA 510(k) clearances or EU MDR certifications for devices similar to your target product, especially concerning risk classification (e.g., Class II vital signs monitors) and predicate devices.
  • Assess their experience with integrating patient monitoring data into existing hospital IT infrastructure, confirming their capabilities in secure data transmission protocols (e.g., HL7, FHIR) and adherence to cybersecurity standards like IEC 81001-5-1.
  • Demand evidence of their clinical validation processes and human factors engineering (HFE) expertise, ensuring the device's usability, accuracy, and safety for the intended user environment and patient population, particularly for critical care applications.
  • Investigate their supply chain resilience for critical medical-grade components, such as biocompatible sensors, specialized PCBA components, and display technologies, to mitigate risks of component obsolescence and supply disruptions impacting devices like multi-parameter monitors.
  • Be wary of manufacturers who cannot articulate a clear, robust post-market surveillance plan, including complaint handling, adverse event reporting, and field service support, as this indicates a lack of long-term commitment to product safety and compliance.

Frequently Asked Questions

What specific regulatory clearances are critical for patient monitoring equipment?

For devices marketed in the US, an FDA 510(k) premarket notification or PMA is typically required, depending on the device's risk classification. In Europe, compliance with the Medical Device Regulation (MDR) and obtaining a CE Mark is essential. Additionally, manufacturers must operate under a Quality Management System compliant with ISO 13485 and FDA 21 CFR Part 820 (Quality System Regulation).

How do I ensure secure data interoperability for a new patient monitoring system?

Prioritize manufacturers with proven expertise in implementing secure communication protocols like HL7, FHIR, and DICOM for integration with EHR/EMR systems. Request detailed cybersecurity documentation outlining their risk management per ISO 14971, encryption methods, and compliance with standards such as IEC 81001-5-1 to protect patient health information.

What's the difference between an OEM and a contract manufacturer for patient monitoring devices?

An Original Equipment Manufacturer (OEM) typically designs, manufactures, and markets their own branded patient monitoring products, carrying full regulatory responsibility. A contract manufacturer (CM) builds devices designed by another company, often specializing in specific processes like PCBA, final assembly, or sterilization, following the client's design and QMS, though they may also handle aspects of design transfer and regulatory submission support.

Why is human factors engineering critical for patient monitoring equipment?

Human factors engineering (HFE) is crucial because patient monitoring devices are used in high-stakes clinical environments where user errors can have severe consequences. HFE ensures the device's interface, alarms, and workflows are intuitive, minimize cognitive load, and prevent misuse or misinterpretation of vital signs data, directly contributing to patient safety and clinical efficiency, as guided by standards like IEC 62366.

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