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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // Diagnostics & IVD

Diagnostics & IVD

Assays, point-of-care testing, sequencing and lab instruments. 44 companies listed.

Menlo Park, CA  ·  Series A  ·  $11.75M raised  ·  Submission pending

Builds CoagCare, a handheld meter and single-use test card that characterizes whole blood coagulation from a single drop in under 10 minutes.

Linkoping, Sweden  ·  Est. 2010  ·  Growth  ·  510(k) cleared

Quantitative MRI software that measures fat and muscle composition from a whole-body scan and returns body composition biomarkers for metabolic and musculoskeletal assessment.

Goleta, CA  ·  Unknown  ·  510(k) cleared

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.

Hanover, NH  ·  Est. 2016  ·  Unknown  ·  510(k) cleared

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.

San Diego, CA  ·  Series C  ·  510(k) cleared

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.

New York, NY  ·  Series A  ·  $19.4M raised  ·  Not a regulated device

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.

Richmond, VA  ·  Unknown  ·  Submission pending

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.

Austin, TX  ·  Bootstrapped  ·  De Novo granted

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.

Cork, Ireland  ·  Est. 2021  ·  Unknown  ·  Over 11 million euros raised  ·  Breakthrough designation

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.

Sunnyvale, CA  ·  Est. 2014  ·  Public  ·  510(k) cleared

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, OH  ·  Growth  ·  PMA approved

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.

South San Francisco, CA  ·  Est. 2015  ·  Acquired  ·  Not a regulated device

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.

Emeryville, CA  ·  Est. 2013  ·  Series D+  ·  $195M raised  ·  510(k) cleared

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.

Brisbane, CA  ·  Est. 2014  ·  Public  ·  PMA approved

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.

Menlo Park, CA  ·  Est. 2016  ·  Public  ·  Submission pending

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.

Sydney, Australia  ·  Est. 2018  ·  Series C  ·  $240M raised  ·  510(k) cleared

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.

Santa Clara, CA  ·  Est. 2015  ·  Public  ·  510(k) cleared

Makes a credit card sized ECG recorder that captures cardiac signals along three non-coplanar axes and synthesizes a 12-lead ECG from them.

Southlake, TX  ·  Public  ·  510(k) cleared

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.

Denver, CO  ·  Unknown  ·  PMA approved

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.

Dublin, Ireland  ·  Growth  ·  De Novo granted

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.

Durham, NC  ·  Est. 2026  ·  Unknown

Building real time 3D ultrasound systems meant to replace 2D imaging for procedures such as vascular access and central line placement.

Menlo Park, CA  ·  Est. 2023  ·  Unknown  ·  510(k) cleared

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.

Bengaluru, India  ·  Est. 2017  ·  Unknown

Builds robotic microscopes and vision guided scanning systems for cancer diagnostics and digital pathology.

Los Angeles, CA  ·  Seed  ·  510(k) cleared

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.

Unknown  ·  In development

Develops plasma and urine proteomic panels for early disease detection, and is building a wearable patch that tracks inflammation after a heart attack.

Melbourne, Australia  ·  Unknown  ·  Breakthrough designation

Builds a wearable patch with DNA-based sensors on microneedles that continuously measures drug and biomarker levels. First product targets vancomycin therapeutic drug monitoring.

Austin, TX  ·  Unknown  ·  Breakthrough designation

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.

Baltimore, MD  ·  Est. 2014  ·  Seed  ·  510(k) cleared

Develops non-invasive urine tests for lung infections. Its MycoMEIA Aspergillus Assay is a urine ELISA used as an aid to diagnosing invasive aspergillosis.

Rochester, MN  ·  Est. 2026  ·  Unknown  ·  Not a regulated device

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.

Zurich, Switzerland  ·  Est. 2024  ·  Seed  ·  In development

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.

Philadelphia, PA  ·  Acquired  ·  510(k) cleared

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.

Princeton, NJ  ·  Est. 2018  ·  Seed  ·  Submission pending

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.

Denmark  ·  Unknown  ·  510(k) cleared

Sells Arthur, a robot that captures standardized ultrasound images of hand and wrist joints, and Diana, the software that analyzes them for rheumatology.

San Marcos, TX  ·  Est. 2016  ·  Series A  ·  510(k) cleared

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.

Tel Aviv, Israel  ·  Est. 2011  ·  Unknown  ·  $124M raised  ·  510(k) cleared

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.

Paris, France  ·  Seed  ·  $18M raised  ·  CE mark

Robotic platform called Swan that captures standardized full-body dermoscopic skin images and tracks changes over time with AI.

Dehradun, India  ·  Est. 2016  ·  Series A  ·  $7M Series A in 2026 raised  ·  Submission pending

Builds the Spandan line of smartphone-connected ECG devices for personal, clinical and institutional cardiac screening, with remote physician review.

San Francisco, CA  ·  Series A  ·  $45M raised  ·  PMA approved

Sells the Teal Wand, an FDA-authorized self-collection device for at-home HPV cervical cancer screening, with samples run by a partner lab.

San Diego, CA  ·  Est. 2015  ·  Series C  ·  510(k) cleared

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.

Cambridge, UK  ·  Est. 2017  ·  Seed  ·  CE mark

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.

Miami, FL  ·  Unknown  ·  510(k) cleared

Builds SmartVertigo, a portable vestibular assessment system that records and classifies nystagmus during positional testing using a smartphone and a light-blocking headset.

Sydney, Australia  ·  Est. 2018  ·  Series A  ·  $19M raised  ·  Submission pending

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.

Utrecht, Netherlands  ·  Est. 2017  ·  Series B  ·  De Novo granted

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.

Stony Brook, NY  ·  Est. 2019  ·  Unknown  ·  510(k) cleared

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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