Point Of Care Device Manufacturers

Based in Monroe Township, NJ, Access Bio, Inc. manufactures rapid diagnostic tests (RDTs) for point-of-care medical screening. They develop and produce diagnostic kits under their CareStart™ brand, offering solutions for COVID-19, Flu A&B, and G6PD deficiency, suitable for preliminary and emergency medical use.

Based in San Marcos, CA, ACI Medical is a biomedical engineering firm specializing in the research, development, and manufacture of therapeutic medical products and technologies. The company offers contract manufacturing and custom molding services, including expertise in miniature pumps, for point-of-care device manufacturers.

ACON Laboratories, Inc. is a San Diego, CA-based medical device manufacturer specializing in point-of-care testing (POCT). They provide diagnostic devices such as urine reagent test strips, blood glucose meters, and handheld devices for cholesterol, coagulation, and hemoglobin. ACON also develops rapid lateral flow tests for infectious diseases.

American Diagnostic Corporation (ADC) manufactures diagnostic instruments for healthcare professionals and institutions. They produce devices like Adcuff Plus reusable cuffs and clock face gauges, known for their design and quality. Over 50% of their products are assembled, tested, and packaged in New York, serving customers for over 40 years.

Based in Houston, TX, AggreDyne, Inc. develops and manufactures medical diagnostic tools, including the FDA-cleared AggreGuide A-100 for on-demand platelet function testing. Utilizing patented light scattering technology, their in-vitro diagnostic products serve hospital and physician office laboratories, improving patient care.

Alfa Scientific Designs, Inc., based in Poway, CA, specializes in the development and manufacturing of rapid immunoassay point-of-care tests. The company offers comprehensive product development and manufacturing services, providing solutions for the diagnostic industry. They focus on delivering high-quality, efficient testing devices.

Alliance Tech Medical, Inc. manufactures and distributes a comprehensive line of respiratory disease management products. Their offerings include various peak flow meters, electronic PEF and FEV1 monitors, inhaler technique training devices, and pMDI holding chambers for both professional and home use.

Based in Shreveport, LA, American Screening Corp manufactures and supplies rapid on-site drug and alcohol test kits. They offer various point-of-care devices such as drug testing cups, dip cards, saliva tests, and breathalyzers. The company serves workplaces, clinics, and programs nationwide.

Based in Parsippany, NJ, Ascensia Diabetes Care is a global company dedicated to improving the health of people with diabetes. The company manufactures and provides a range of blood glucose monitoring systems, including its renowned CONTOUR® portfolio. These point-of-care devices support individuals in managing diabetes effectively.

Based in Santa Barbara, CA, Atomica Corp. specializes in rapid prototyping and scalable production of microfabricated components and microfluidic building blocks. They offer expertise in complex material integration for molecular diagnostics, drug delivery, and biotechnology applications, making them a crucial supplier for point-of-care device manufacturers.

Based in Austin, TX, Attogene Corporation specializes in end-to-end lateral flow assay (LFA) development and manufacturing. They offer universal LFA products, including Quantum Dots, Gold, and Europium-based kits, alongside human IgG/IgM serology kits. Attogene also provides a range of cyanotoxin test kits and comprehensive testing services.

Baebies develops and manufactures the FINDER® multifunctional diagnostic platform, enabling rapid, near-patient molecular, immunoassay, coagulation, and chemistry tests. Powered by digital microfluidics, their compact system delivers fast and reliable results for all ages, facilitating timely clinical interventions.

Based in Morrisville, NC, BioMedomics Inc. is a point-of-care diagnostics company. The firm develops and provides novel, rapid point-of-care tests to aid in the diagnosis of critical diseases. They focus on creating innovative diagnostic solutions for healthcare professionals.

Based in Irvine, CA, Biomerica specializes in developing and manufacturing rapid lateral flow assays and point-of-care in vitro medical devices. They provide contract development and manufacturing services, taking products from concept through regulatory compliance to final production for the healthcare industry.

Based in Big Lake, MN, Bionote USA Inc. manufactures advanced Point-of-Care (POC) diagnostic devices for veterinary medicine. Their Vcheck F and Vcheck H analyzers deliver rapid, quantitative results for biomarker tests across canine, feline, and equine care, leveraging europium technology for high sensitivity.

Biotex Inc., based in Houston, TX, is an ISO-certified, FDA-registered medical device CDMO. They specialize in the design, development, and manufacturing of life-changing medical devices. With over 25 years of expertise, Biotex offers comprehensive services, transforming novel ideas into groundbreaking solutions for patient care.

Based in El Cajon, CA, Calbiotech is an FDA-registered and ISO 13485-certified CDMO. They specialize in custom assay development for IVDs, covering ELISA, molecular, and multiplex formats. The company provides end-to-end IVD production, including reagent formulation and filling services.

ClearChem Diagnostics manufactures powerful and reliable benchtop immunoassay analyzers for various medical applications. Their devices feature a space-saving design, user-friendly interfaces, and support a comprehensive menu of more than 50 diagnostic tests, serving the point-of-care and laboratory diagnostics market.

Based in San Diego, CA, Dexcom specializes in manufacturing Continuous Glucose Monitoring (CGM) systems. The company develops glucose biosensing technology, providing devices like the Dexcom G7 that deliver real-time glucose readings. These systems help individuals manage diabetes and track their overall health with accurate data.

Based in Coralville, IA, Digital Diagnostics develops FDA-cleared AI diagnostic platforms for point-of-care medical testing. Their LumineticsCore AI diagnoses diabetic retinopathy without physician input, increasing patient access to specialty services and expediting referrals. The company pioneers AI-driven healthcare, enhancing accessibility and quality.

EKF Diagnostics develops and manufactures point-of-care in-vitro diagnostic devices and tests, providing quick, accurate results for rapid decisions at the patient’s location. The company also supplies high-quality reagents, enzymes, and components for research, biotech, and pharma, supporting industrial and life sciences applications.

Based in San Diego, CA, Epitope Diagnostics Inc. is a medical device manufacturer specializing in in-vitro diagnostics. They develop and produce niche immunoassays, including ELISA kits and rapid tests, utilizing CLIA chemiluminescence and automated ELISA platforms. The company offers diagnostic solutions to the global healthcare community.

Based in Irvine, CA, Fluxergy Inc. manufactures an all-in-one benchtop lab platform for rapid, multimodal point-of-care assay. It features a scalable ecosystem supporting molecular (PCR), immunochemistry, cytometry, and electrochemistry, enabling diverse diagnostic capabilities on a single test card for human and animal health.

GE HealthCare Technologies Inc. develops and manufactures patient-focused medical technologies and integrated solutions. Specializing in precision care, the company provides diagnostic ECG, ultrasound, anesthesia delivery, patient monitoring, and maternal & infant care systems to enhance hospital efficiency and patient outcomes.

Abbott Point of Care manufactures advanced diagnostic devices for rapid testing directly at the point of care. They offer solutions such as the i-STAT hs-TnI CARTRIDGE for myocardial infarction diagnosis, BinaxNOW™ for COVID-19/Flu A&B, and ID NOW™ COVID-19 2.0 ASSAY. These devices deliver quick, accurate results to aid real-time clinical decision-making.

Based in Malvern, PA, Philips Ambulatory Monitoring and Diagnostics delivers smart, comprehensive, and connected solutions for patient monitoring and diagnostics. They specialize in ECG solutions, cardiac ambulatory monitoring, and implantable devices, transforming workflows and enabling proactive patient management across care settings.

Based in Horsham, PA, Gold Standard Diagnostics Horsham manufactures rapid environmental, food, and life sciences test systems. The company develops immunochemistry products and methods, including rapid test kits, to serve research, industry, and environmental monitoring. They provide solutions for water quality and food contaminant testing.

Based in Santa Maria, CA, Hardy Diagnostics manufactures rapid lateral flow antigen and antibody tests, serving laboratory partners with accessible diagnostic tools. The ISO-certified company specializes in clinical diagnostics, pharmaceutical microbiology, and food safety testing, producing its solutions in the USA.

Based in Houston, TX, Healgen develops and manufactures in-vitro diagnostics (IVD) devices. The company specializes in point-of-care products, including FDA-cleared rapid antigen tests for COVID-19/Flu A&B, multi-drug urine screen cups, and accurate fentanyl rapid tests.

Hologic is a medical technology company specializing in molecular diagnostics, oncology, and women's health. They develop and manufacture innovative screening technologies, diagnostic systems, and collection devices. Hologic provides direct point-of-care and laboratory solutions, focusing on improving patient outcomes through advanced medical products.

Based in San Clemente, CA, ICU Medical manufactures medical devices for point-of-care IV therapy. Their product portfolio includes infusion pumps, safety software, IV solutions, needlefree IV connectors, and vascular access catheters. They also offer solutions for pharmacy preparation and airway management.

Based in Seattle, WA, InBios International, Inc. designs, develops, and manufactures superior immunodiagnostics for infectious diseases. They provide FDA-cleared, CLIA-waived point-of-care respiratory diagnostics, including tests for COVID-19, Flu A&B, and Strep A. All products are made in their US-based, GMP-compliant facility.

Based in Austin, TX, International Biomedical designs, manufactures, and distributes innovative neonatal and perinatal products. The company focuses on developing specialized medical devices for critical care in infants and newborns.

Kephera Diagnostics specializes in developing immunoassays using both lab-based and point-of-care technologies. Based in Framingham, MA, the company focuses on delivering advanced diagnostics for a range of infectious diseases, providing crucial tools for rapid and accessible health assessments.

Based in Kirkland, WA, Kestra Medical Technologies develops wearable medical devices for cardiac patients. They integrate digital healthcare, smart wearables, and mobile connectivity to provide diagnostic and therapeutic technologies. Their innovative ASSURE System focuses on protecting and supporting at-risk patients with intuitive, lifesaving technology.

Based in Brisbane, CA, LeeMAH Electronics is a custom contract manufacturer of electronic assemblies. The company provides end-to-end manufacturing solutions including PCBA, cable assembly, box build, and testing services. They specialize in high-mix, low-to-medium volume needs for various sectors, notably the medical device industry.

Based in Bedford, MA, Medica Corporation manufactures simple-to-use, highly reliable diagnostic blood testing analyzers. They develop clinical chemistry, blood gas, and electrolyte systems designed to enhance productivity and quality of care in small to medium-size in vitro diagnostic laboratories, focusing on global healthcare cost reduction.

Based in South Jordan, UT, Merit Medical Systems, Inc. manufactures proprietary disposable medical devices. They specialize in products for interventional, diagnostic, and therapeutic procedures across cardiology, radiology, oncology, critical care, and endoscopy. The company serves hospitals and physicians worldwide with patient care solutions.

Based in Saint Paul, MN, MGC Diagnostics is a medical technology company specializing in cardiorespiratory diagnostic systems. They develop and provide products for pulmonary function tests, metabolic tests, indirect calorimetry, and stress ECG. Solutions also include remote patient monitoring and asthma management.

Based in Austin, TX, Nanohmics Inc. is an R&D and engineering firm. They specialize in innovative materials, advanced instrumentation, and custom-engineered sensing technologies. Their multidisciplinary team designs and develops measurement platforms for detection, identification, and quantification, providing smart solutions for point-of-care device manufacturers.

Natus Medical Incorporated provides innovative solutions for screening, diagnosing, and treating disorders of the brain, neural pathways, and sensory nervous systems. Specializing in medical devices and neuro/sensory products, they aim to simplify complex care and research for healthcare professionals.

Norwood Medical specializes in precision medical device manufacturing and medtech innovations. The company offers services like post-processing and assembly, supporting demanding markets including cardiovascular, minimally invasive surgery, orthopedics, and robotic-assisted surgery. They provide reliable performance and quality for advanced medical technology solutions.

Based in Alpharetta, GA, Nox Medical manufactures advanced portable polysomnography (PSG) and home sleep testing (HST) devices. The company develops user-friendly solutions, integrating AI to simplify sleep diagnostics and expand access to care. Products like the Nox A1s™ PSG System and Nox T3s HST Device support modern sleep medicine.

Based in Austin, TX, Nuclein, LLC develops and manufactures the DASH Rapid PCR System, a point-of-care platform. This FDA-cleared and CLIA-waived system provides lab-quality, sample-to-answer PCR results for tests like SARS-CoV-2 & Flu A/B in just 15 minutes.

Based in Cortlandt Manor, NY, Polymedco, LLC manufactures the PATHFAST point-of-care analyzer. This bench-top chemiluminescent immunoassay system provides core-lab quality results from whole blood or plasma samples in under 17 minutes. It supports cardiac biomarker testing for quick, accurate diagnostics, enhancing patient care.

Based in Monmouth Junction, NJ, Princeton BioMeditech Corporation develops and manufactures advanced rapid, point-of-care diagnostic products. They offer an extensive menu of one-step tests for professional and in-home use, covering infectious disease, cardiac care, tumor markers, drugs of abuse, fertility, and veterinary applications.

Phamatech, Inc., based in San Diego, CA, is a US manufacturer of rapid diagnostic devices and on-site testing products. They provide comprehensive drug testing solutions, including laboratory services for medication monitoring, illicit drugs, alcohol, and genetics. The company ensures accurate results through in-house manufacturing and high certification levels.

Based in Rocklin, CA, Precision Medical Products manufactures innovative tubeless and cordless mobile DVT prevention devices. Solutions like VenaOne® and Circul8 Pro® facilitate active patient recovery and seamless care transitions from hospital to home, incorporating connected data technology.

Based in Livermore, CA, POC Medical Systems Inc. develops and manufactures point-of-care (POC) diagnostic systems. Their Pandora CDx™ platform offers rapid, accurate, and portable disease screening using miniaturized lab-in-a-box microfluidic technology. MammoAlert™, a breast cancer pre-screening tool, provides high sensitivity from a few blood drops.

Based in Cortlandt Manor, NY, Polymedco develops and provides a portfolio of Point-of-Care (POC) diagnostic devices, like the PATHFAST Analyzer. The company focuses on enabling early detection of life-threatening diseases, partnering with healthcare systems to make diagnostics more accessible, affordable, and effective for faster patient care decisions.

QuidelOrtho manufactures diagnostic platforms and a diverse range of on-demand tests, providing vital health information and actionable intelligence across various settings. Their offerings include the SOFIA™ Platform, a next-generation benchtop diagnostic testing analyzer for rapid results.

Resonetics offers advanced engineering, product development, prototyping, and micro-manufacturing services for the MedTech and Life Sciences industries. They specialize in medical devices and diagnostics, including bioelectronics, sensors, and microfluidic laminates. Capabilities encompass laser processing, Nitinol processing, metal fabrication, and battery development for complex point-of-care devices.

Based in Bland, MO, Roberson Machine Company specializes in precision CNC machining, including milling, turning, wire EDM, and 3D printing. They provide comprehensive manufacturing from prototype to production for medical devices, aerospace, automotive, and various other industries across the United States.

Roche is a research-based healthcare company dedicated to advancing science and bringing lab-quality solutions to point of care and patient self-testing. They focus on innovation to enable timely treatment decisions and a healthier future.

Based in San Diego, CA, Sekisui Diagnostics is a global partner developing and manufacturing highly accurate diagnostic solutions. For over 40 years, they have innovated biochemistry products and rapid tests for conditions like Influenza and Strep, improving patient outcomes worldwide.

Based in San Antonio, TX, Seno Medical develops the Imagio® Breast Imaging System, an innovative diagnostic device. It utilizes non-invasive laser light and sound to provide real-time functional imaging, aiding in the differentiation of malignant tissue. This system aims to simplify breast cancer diagnostics for patients and clinicians.

Based in Newton, MA, Sherlock Biosciences develops rapid, accurate, and affordable diagnostic tools for DNA and RNA detection. Leveraging CRISPR and synthetic biology, the company creates point-of-need devices that enable decentralized testing to democratize access to health decisions.

Based in Eden Prairie, MN, Smart Diagnostic Devices specializes in manufacturing portable, touch-screen audiometers and compliant diagnostic devices. These solutions are specifically designed for occupational health professionals, featuring cloud storage and ensuring reliable diagnostic capabilities.

Based in Vernon Hills, IL, Snap Diagnostics, LLC manufactures home sleep test kits for diagnosing sleep apnea. These point-of-care devices measure six essential sleep data channels: airflow, respiratory effort, oximetry, heart rate, body position, and sound. Data is analyzed by software and technicians.

Based in Santa Maria, CA, SNS Biosystems is an FDA and California FDA registered facility that manufactures, sells, and services the SNS Biosensor™. The company specializes in producing point-of-care devices, ensuring compliance and validation for its medical diagnostic products.

Based in Eden Prairie, MN, Surmodics, Inc. manufactures medical devices. They offer contract development and scalable manufacturing for complex medical devices, including customized hydrophilic and drug-delivery coatings for intravascular devices. Additionally, Surmodics supplies chemical components for in vitro diagnostic immunoassay tests and microarrays.

Based in Anaheim, CA, Teco Diagnostics develops and manufactures private-label, over-the-counter medical test kits and IVD solutions. The company provides FDA-registered and CE-marked products for global distribution, specializing in urinalysis, rapid tests, clinical chemistry, and instrumentation for diagnostic companies.

Based in Carlsbad, CA, True Diagnostics, Inc. specializes in the research, development, and manufacturing of advanced rapid in-vitro diagnostic tests. The company develops innovative solutions for preventing, diagnosing, and treating medical conditions, offering lab-quality results for point-of-care testing. They also provide assay development services.

Truvian Sciences Inc., based in San Diego, CA, manufactures the FDA-cleared TruVerus™ automated benchtop analyzer. This multimodal device delivers lab-accurate, comprehensive blood test results from a single small sample in minutes. It integrates clinical chemistry, immunoassay, and hematology for use in decentralized, point-of-care settings.

Diasorin specializes in immunodiagnostics and molecular diagnostics, providing in vitro diagnostic kits and reagents. The company develops solutions such as the LIAISON PLEX assays for faster, more accurate triage and bloodstream infection diagnostics, serving the lab diagnostics market.

Based in Plano, TX, Virtex provides precision-engineered, compliant manufacturing of high-reliability electronic solutions for Class I-III medical devices. Services encompass engineering, testing, PCB assembly, and full system integration. Virtex supports the medical device, aerospace, defense, space, and industrial markets from six U.S. facilities.

Based in Pullman, WA, VMRD, Inc. manufactures veterinary diagnostics. The company produces USDA-licensed test kits, reagents, and Point-of-Care products like readers for detecting various animal diseases. VMRD's portfolio includes ELISA kits and FA reagents, complementing their comprehensive biologics testing services.

Wainamics specializes in the design and manufacturing of microfluidic cartridges. These essential components are tailored for in vitro diagnostic (IVD) tests, enabling rapid, accurate, and reliable results in various Point of Care applications and life science research platforms.

EKF Diagnostics USA (Stanbio Laboratory) manufactures medical devices, including point-of-care hemoglobin analyzers like DiaSpect Tm, hematocrit testing centrifuges, and specialized reagents. They produce β-Hydroxybutyrate LiquiColor® tests for diabetes care under the Stanbio Chemistry brand, supplying various medical facilities.

Based in Houston, TX, IntelliGenome develops decentralized CRISPR-based diagnostic devices for point-of-care use. Their breakthrough technology platform provides ultra-sensitive, rapid test results for early pathogen detection and monitoring treatment response, including solutions like CRISPR-TB.

Based in Malvern, PA, LifeScan is a direct manufacturer of point-of-care medical devices. The company specializes in developing and providing products under its OneTouch® brand, focused on improving the quality of life for people managing diabetes. LifeScan offers diagnostic tools designed for personal use.

Medtronic is a global medical technology company manufacturing a wide range of devices, including acute care and monitoring technologies. These innovations support clinicians in predicting and preventing adverse patient events. Medtronic directly provides point-of-care medical device manufacturing services with extensive operations across the United States.

Orange Biomed manufactures a portable, lab-accurate A1C point-of-care device for diabetes monitoring. Their innovative device provides precise results unaffected by hemoglobin variants, enhancing diagnostic reliability for diverse patient populations. It offers rapid testing and supports earlier prevention and treatment options.

Based in San Jose, CA, Precigenome develops and manufactures microfluidic platforms and diagnostic devices. Their offerings include portable mini PCR and digital PCR machines, which are suitable for point-of-care applications. They also produce microfluidic controllers for flow/pressure control, droplet applications, and single-cell studies.

Based in San Diego, CA, REAGEN INC develops and manufactures diagnostic kits. Specializing in PCR, NGS, ELISA, and lateral flow rapid test kits, their products support human and animal infectious disease diagnostics, food safety, and drug of abuse testing. They also supply raw materials.

Siemens Healthineers USA manufactures advanced multi-parameter point-of-care analyzers, such as the DCA Vantage Analyzer, for monitoring glycemic control in diabetes and detecting early kidney disease. The company provides a range of innovative healthcare solutions and diagnostic technologies aimed at improving patient care.

Based in Weston, FL, Stryker is a global medical technology company manufacturing a wide array of innovative products. They develop and supply medical devices and technologies that impact over 150 million patients annually worldwide, including solutions relevant for point-of-care applications for healthcare professionals.

Portable Diagnostic Systems LLC (PDS) is a biotech startup that specializes in developing a next-generation microfluidics-based drug testing platform. This innovative technology is designed for rapid, point-of-care diagnostics, primarily targeting applications and needs within law enforcement agencies for efficient testing.

Based in Richmond, TX, Velentium Medical designs and manufactures Class II and Class III medical devices. The company transforms intellectual property into safe and secure products, offering comprehensive services including R&D, manufacturing, cybersecurity, and test systems for the medical device industry.

Advin Biotech is a U.S. manufacturer specializing in premium quality in-vitro diagnostic (IVD) point-of-care devices. The company produces a complete line of drugs of abuse tests, including urine and oral fluid tests in cup or dipcard formats, as well as COVID-19 antigen tests for home use. They leverage innovative R&D and FDA-registered manufacturing capabilities.

Based in Carlsbad, CA, Argonaut Manufacturing Services is a contract manufacturing organization (CMO) for pharmaceutical, diagnostic (IVD), and life science products. They provide aseptic drug fill finish, lyophilization, and drug-device combination product manufacturing. Services also include non-aseptic fill finish and analytical & quality control support for complex medical devices.

Avioq, Inc., based in Durham, NC, is an in-vitro diagnostic medical device company specializing in IVD product development, production, and distribution. It offers flexible IVD contract manufacturing services within an FDA licensed and ISO 13485 certified environment, guiding clients to commercialize quality IVD products.

Based in Medford, NY, Chembio Diagnostic Systems, Inc. specializes in the development, manufacturing, and commercialization of rapid and accurate point-of-care diagnostic solutions. The company provides easy-to-use products for detecting and monitoring infectious diseases, including tests for Preeclampsia, Syphilis, and HIV.

Based in York, PA, Conductive Technologies (CTI) specializes in manufacturing sensors and biosensors, offering expertise in conductive printing, ablation, and membrane switches. The company provides precise processing and extensive product development services, making them a crucial supplier for components used in advanced point-of-care diagnostic devices.

Based in Tustin, CA, DeviceLab Inc. is a medical device development and product design firm. They specialize in engineering and prototyping in-vitro diagnostic instruments and clinical laboratory systems. Services encompass industrial design, mechanical, systems, electronics, software engineering, UI/UX, and pilot production.

Based in Morgan Hill, CA, Diagnostics for the Real World (DRW) specializes in developing and manufacturing decentralized molecular diagnostic devices. The company focuses on creating accessible, rapid, and accurate testing solutions for various health conditions. They provide critical diagnostic capabilities for point-of-care applications, improving patient access to testing.

Fortis Life Sciences, based in Grand Rapids, MI, is a CDMO specializing in ultra-sensitive quantitative diagnostic assay manufacturing. They provide lateral flow device development and production, often used for Point-of-Care. The company offers integrated reagents, components, and CDMO solutions for diagnostics firms.

Abbott manufactures innovative point-of-care medical devices, specifically the FreeStyle Libre 3 Plus continuous glucose monitoring system. This advanced sensor technology provides users with real-time glucose level data, enabling confident health management and informed decision-making. Their devices support patients in reducing A1C levels effectively.

Gold Standard Diagnostics provides comprehensive diagnostic solutions, offering product development, engineering, and manufacturing services for diagnostic instruments and assays. They feature an extensive product menu designed to enhance laboratory efficiency and address various testing needs, including solutions for Lyme disease and COVID-19.

Huntleigh Healthcare manufactures innovative point-of-care medical equipment for healthcare professionals. Their Diagnostic Products Division specializes in devices for vascular assessment, treatment, obstetrics, and patient monitoring. Products include Dopplex handheld Dopplers, Sonicaid fetal monitors, and Smartsigns patient monitoring systems for efficient diagnosis.

Keller Technology Corporation specializes in the custom manufacturing of medical equipment. They build diagnostic instruments and various other devices designed for demanding healthcare and medical applications. The company provides essential services for "Point Of Care Device Manufacturers," leveraging its expertise in complex medical device production.

Based in Hudson, WI, Hudson Medical Innovations manufactures high-performance components and assemblies for the medical device industry. They specialize in wearable biosensors, microfluidics for rapid diagnostic test results, advanced wound care, and patient monitoring applications. The company offers medical device manufacturing capabilities to clients in the healthcare market.

Masimo is a global medical technology company headquartered in Irvine, CA, specializing in the development and manufacturing of innovative noninvasive patient monitoring technologies. The company provides a wide array of medical devices and sensors designed for various healthcare settings, supporting clinicians with advanced insights at the point of care.

MediPines Corporation, based in Linda, CA, specializes in developing and manufacturing point-of-care medical devices. Their flagship product, the AGM100, is a non-invasive system designed for high-accuracy assessment of respiratory impairment severity, delivering actionable results in under two minutes for early detection and management. Products are designed and manufactured entirely within the United States.

OPTI Medical Systems, Inc. designs and manufactures point-of-care and laboratory diagnostic solutions. The company leverages advanced optical fluorescence technology to develop accurate, cost-effective products. They provide solutions for infectious disease diagnostics and point-of-care blood gas and electrolyte analysis, combining accuracy with convenience.

Based in Irvine, CA, Planet Innovation is a MedTech Contract Development and Manufacturing Organization (CDMO) specializing in product development and high-volume manufacturing. They leverage innovation and strong capabilities to build medical instruments, serving global diagnostics clients from their US facility.

Based in Germantown, MD, Senseonics manufactures innovative long-term implantable continuous glucose monitoring (CGM) systems. The company specializes in developing devices like the Eversense CGM System, designed for prolonged use and improving glycemic control for diabetes management at the point of care.

Tempus is a technology company specializing in in vitro diagnostic (IVD) devices. They develop advanced RNA Next-Generation Sequencing (NGS) products, such as the Tempus xR IVD, which has received U.S. FDA 510(k) clearance. Based in Peachtree Corners, GA, Tempus focuses on creating innovative diagnostic tools.

TytoCare manufactures smart clinic solutions that enable remote physical exams for healthcare providers and families. Their devices facilitate comprehensive primary and urgent care, as well as condition management, allowing access to quality healthcare from any location.

Zoetis is a global animal health company specializing in the development and manufacture of medicines, vaccines, and diagnostic products. They produce advanced point-of-care veterinary devices, including the i-STAT Alinity v handheld analyzer, which provides rapid blood gas, electrolyte, and chemistry testing for animal healthcare professionals.

Based in Santa Ana, CA, Autonomous Medical Devices Incorporated (AMDI) develops advanced point-of-care diagnostic devices. Their flagship product, AMDI Fast PCR, is a CLIA-waivable molecular system designed for rapid detection of key pathogens in less than 10 minutes, targeting urgent care, primary care, and retail settings.

Cepheid manufactures molecular diagnostic testing systems, like the GeneXpert, for rapid, accessible results. They specialize in multi-target tests for respiratory, women's, and global health, providing point-of-care solutions. The company aims to improve patient outcomes through widespread access to crucial diagnostics.

Based in San Diego, CA, CTK Biotech Inc. develops and manufactures innovative immunodiagnostic tools and point-of-care diagnostic test kits. Serving the global In Vitro Diagnostics (IVD) community, the company offers reliable diagnostic products designed for various healthcare applications worldwide.

Abbott Diagnostics develops and manufactures point-of-care and rapid diagnostic devices, providing solutions for key health and therapeutic areas. They deliver quick, reliable answers to users. Leveraging decades of expertise in virus detection, Abbott builds trusted diagnostic tools for today's needs and future pandemic preparedness.

Freudenberg Medical is a Contract Development and Manufacturing Organization (CDMO) for medical device and IVD products. They provide end-to-end support from ideation, design, and development to series manufacturing. Leveraging vertically integrated capabilities and deep materials expertise, the company operates facilities in Southern California.

HDA Technology is a medical device contract manufacturer based in Los Angeles, CA. They provide compliant pilot production services and on-site prototyping for various medical devices. Their expertise supports companies seeking specialized manufacturing for critical healthcare technologies, including Point of Care devices.

Based in Cherry Hill, NJ, In Vitro Diagnostic Solutions (IVDS) develops point-of-care platforms and diagnostics for rare metabolic diseases. They offer contract assay development and engineering services, featuring the IVDS Onsight platform and urine test strips. Their solutions deliver rapid, simple-to-use diagnostic capabilities for healthcare providers and patients.

MiCo Biomed USA specializes in advanced microfluidic approaches designed to dramatically improve immunoassay testing performance. They provide innovative solutions across a range of diagnostic testing platforms, directly supporting the development and manufacturing of point-of-care devices.

Abbott Molecular manufactures FDA-approved molecular diagnostic devices and systems. Their offerings include self-collection kits for HPV and STI screening, improving access to cervical cancer screening and enabling at-home sample collection. They also provide pre-analytical instruments to enhance clinical and operational efficiencies.

OraSure Technologies, Inc. pioneers non-invasive testing devices and sample collection tools. The company provides rapid, decentralized diagnostic solutions, including tests for HIV, Hepatitis C, Ebola, influenza, and adherence testing. It aims to empower individuals, healthcare providers, and researchers with actionable insights to improve health outcomes.

Phillips Medisize, a contract development and manufacturing organization (CDMO), partners with pharmaceutical, medtech, and in vitro diagnostic companies. They provide comprehensive design and manufacturing services for products like consumables and cartridges. The company assists clients with engineering challenges, supporting the development and delivery of medical devices.

Based in Carlsbad, CA, Thermo Fisher Scientific provides and manufactures a comprehensive range of diagnostic solutions, including systems for solid tumor biomarker testing. They offer instruments, high-performance antibodies, and integrated platforms designed to support clinical diagnostics and scientific research efforts.

Abbott Toxicology provides comprehensive drug testing answers through innovative technology. They offer a portfolio of screening options, including onsite point-of-collection devices, oral fluid reagents, and urine test devices. These solutions support workplace drug and occupational health screening, empowering confident decision-making.

Viant Medical specializes in complex electromechanical assemblies, thermoforming, and finished device manufacturing for leading OEMs. They offer design and development, plus extensive manufacturing capabilities for interventional and inhalation medical device solutions, aiming to move MedTech forward.