Diagnostics & IVD
Assays, point-of-care testing, sequencing and lab instruments. 44 companies listed.
Builds CoagCare, a handheld meter and single-use test card that characterizes whole blood coagulation from a single drop in under 10 minutes.
Quantitative MRI software that measures fat and muscle composition from a whole-body scan and returns body composition biomarkers for metabolic and musculoskeletal assessment.
Makes the Metrix handheld molecular diagnostic platform for point of care and over the counter respiratory and STI testing. Spun out of UC Santa Barbara.
Makes Neurora, software that scores video and audio from a standard pediatric behavioral assessment to aid autism spectrum disorder diagnosis in children 18 months through 12 years.
Makes Biolinq Shine, a needle-free forearm patch whose microsensor array reads glucose from the top layers of skin. A color-coded LED on the patch shows the glucose range without a phone, and the device also logs activity and sleep.
Cornell Tech spinout running sequencing-based infectious disease tests from a CLIA lab in Long Island City. Its urine panel covers 44 urogenital pathogens and 16 resistance markers.
Traumatic brain injury test that combines blood biomarkers with digital neurocognitive testing into a single composite score, built to run at the point of care.
Builds SmartRead, a handheld unit that identifies the manufacturer of a patient's implanted pacemaker or defibrillator in the emergency department. Also develops hemodynamic measurement and aerosol drug delivery devices under NIH small business awards.
Builds Wave, software that reads newborn EEG for signs of brain injury without a specialist to interpret the trace. Spun out of University College Cork's INFANT Research Centre.
Point-of-care EEG for acute care. A disposable headband and portable recorder pair with seizure detection and quantitative trending software so bedside staff can start a study without a technologist.
Cleveland Diagnostics develops blood tests that read structural changes in cancer-related proteins. Its IsoPSA test helps urologists decide whether to biopsy men with elevated PSA.
Runs the UroAmp platform, a urine-based tumor DNA test for non-muscle invasive bladder cancer, covering therapy response monitoring and post-treatment surveillance. Veracyte agreed to acquire the company in September 2026.
Makes digital stethoscopes, including the CORE 500 and the 3M Littmann CORE, paired with algorithms cleared to flag murmurs, atrial fibrillation and low ejection fraction.
Develops blood-based cancer screening tests built on cell-free DNA methylation and machine learning. SimpleScreen CRC is its first FDA-approved product; listed on Nasdaq as FRNM in July 2026.
Sequencing-based cancer screening company. Its Galleri test reads cancer-specific methylation patterns in blood to flag signals from multiple cancer types and predict the tissue of origin.
Australian medical AI company behind the Annalise radiology decision-support tools for chest X-ray, CT brain and CT chest, and the Franklin.ai pathology platform.
Makes a credit card sized ECG recorder that captures cardiac signals along three non-coplanar axes and synthesizes a 12-lead ECG from them.
Builds ECG hardware and AI-ECG software intended to detect heart disease from a standard 12-lead resting recording. Its MyoVista wavECG cleared 510(k) in October 2026 without the AI algorithm.
Develops blood tests that quantify liver function from cholate clearance to stage liver disease and guide varices screening. Runs its own CLIA laboratory in Colorado.
At-home sample collection kits tested in its own laboratories. Its Simple 2 Test for chlamydia and gonorrhea took the De Novo that FDA codified at 21 CFR 866.3385.
Building real time 3D ultrasound systems meant to replace 2D imaging for procedures such as vascular access and central line placement.
Builds airway and GI stents, cryo biopsy probes and steerable endobronchial instruments, plus molecular diagnostics for lung cancer triage. Formed under Ajax Health in 2023 and acquired Thoracent in 2025.
Builds robotic microscopes and vision guided scanning systems for cancer diagnostics and digital pathology.
Makes STEDI, a portable bioimpedance spectroscopy device that measures fluid distribution in the head to help assess cerebral fluid volume asymmetry between hemispheres at the bedside.
Develops plasma and urine proteomic panels for early disease detection, and is building a wearable patch that tracks inflammation after a heart attack.
Builds a wearable patch with DNA-based sensors on microneedles that continuously measures drug and biomarker levels. First product targets vancomycin therapeutic drug monitoring.
Runs single-cell microbiology panels that identify organisms and report antimicrobial susceptibility from a patient specimen the same day, without overnight culture. Its pneumonia and urine panels both hold FDA Breakthrough Device designations.
Develops non-invasive urine tests for lung infections. Its MycoMEIA Aspergillus Assay is a urine ELISA used as an aid to diagnosing invasive aspergillosis.
Joint venture between Mayo Clinic and Thermo Fisher Scientific that generates proteomic and genomic data from one million biospecimens and links it to longitudinal clinical records.
Runs a single-cell functional test that exposes a patient's own tumor cells to a library of treatments to see which ones work. Targets hematological malignancies and solid tumors.
Builds Concentriq, a digital pathology software platform for diagnostic laboratories and biopharma. The Concentriq AP-Dx version is FDA cleared for primary diagnosis on scanned surgical pathology slides.
Rutgers spinout building CytoTracker, a handheld device that counts white blood cells from a finger stick sample. Founded out of the university Nano Bioelectronics Lab.
Sells Arthur, a robot that captures standardized ultrasound images of hand and wrist joints, and Diana, the software that analyzes them for rheumatology.
Makes the Halo Vital Signs Monitor, a wearable that tracks pulse oximetry, heart rate, respiratory rate, temperature and posture for clinical, emergency and field use.
Built Sight OLO, a benchtop analyzer that runs a complete blood count from a small blood sample in minutes. The company laid off its remaining staff in April 2026.
Robotic platform called Swan that captures standardized full-body dermoscopic skin images and tracks changes over time with AI.
Builds the Spandan line of smartphone-connected ECG devices for personal, clinical and institutional cardiac screening, with remote physician review.
Sells the Teal Wand, an FDA-authorized self-collection device for at-home HPV cervical cancer screening, with samples run by a partner lab.
Builds TruVerus, a benchtop analyzer that runs clinical chemistry, immunoassay and hematology from one blood sample and returns results in about 30 minutes at the point of care.
Builds rapid point-of-care blood tests for time-critical conditions. Its LVOne test measures GFAP and D-dimer to identify large vessel occlusion stroke in about 10 minutes, for use by paramedics before a patient reaches hospital.
Builds SmartVertigo, a portable vestibular assessment system that records and classifies nystagmus during positional testing using a smartphone and a light-blocking headset.
Builds VxWave, a semi-autonomous robot that acquires 3D vascular ultrasound without a sonographer. First use is mapping and monitoring arteriovenous fistulas in dialysis clinics.
Builds Aletta, an autonomous robotic blood-draw device that images the vein, inserts the needle and collects the sample. CE-marked in Europe; FDA granted De Novo authorization in August 2026.
Device-agnostic ECG analysis software that turns Holter and wearable patch recordings into beat and rhythm reports, including atrial fibrillation detection.
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