Digital Health & SaMD

Sells FDA-cleared AI triage and quantification software for CT and X-ray through its aiOS platform, now built on the CARE foundation model. More than 30 510(k) clearances since 2018.

Sells SwiftMR, software that shortens MRI scan times and improves image quality on existing scanners, plus SwiftSight quantitative imaging. Works with Siemens, GE, Philips and Canon systems without hardware changes.

Allurion makes a swallowable gastric balloon that needs no endoscopy or anesthesia and passes on its own after about four months. It pairs the balloon with a remote care app and scale.

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.

Builds a voice-first clinical AI agent for cardiovascular care that pairs a language model with a deterministic decision engine. First target is heart failure medication titration.

Beacon Biosignals makes the Waveband EEG headband and AI sleep-staging software, and sells brain-function biomarkers to drug developers.

Bunkerhill Health develops FDA-cleared AI algorithms that find cardiovascular and bone disease on imaging and ECGs ordered for other reasons. Hospitals run them through its Carebricks platform.

Builds aprevo, patient-specific spinal interbody implants made from preoperative planning software, plus the single-use instruments that place them. Cleared for lumbar and cervical fusion.

Virtual reality platform for eye exams, covering visual fields, pupillometry, ocular motility, contrast sensitivity and color vision, with EMR integration for clinics.

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.

Develops prescription software treatments for psychiatric and neurological conditions. Its cleared product, Motivista, treats the negative symptoms of schizophrenia as an adjunct to antipsychotic therapy.

Builds vision language models that read imaging studies and draft radiology reports. Acquired by Radiology Partners' Mosaic Clinical Technologies in November 2025.

Builds Spectris, a prescription home-use device that delivers gamma frequency light and sound stimulation for Alzheimer's disease. The device holds Breakthrough Device designation and is in the HOPE trial ahead of an FDA submission.

Builds Brain Interchange, a fully implantable wireless brain-computer interface that records cortical activity and delivers stimulation in a closed loop. In FDA-authorized clinical evaluation for motor rehabilitation after stroke.

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.

Builds FIZE kUO, a digital urine output monitor for fluid management in intensive care, plus a predictive platform called FIZE Optima in development.

Flow Neuroscience makes a home-use tDCS headset paired with a behavioral therapy app for depression. It has sold in the UK and Europe since 2019.

Makes InSightVR, a virtual reality tool that uses a cataract patient's own biometry to simulate vision with different intraocular lenses before surgery. Carrot agreed to acquire the company in October 2026.

The Happy Ring is a sensor ring cleared to diagnose obstructive sleep apnea at home. The company is building a home care platform around it.

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.

Software that connects to a hospital EHR, reads clinical notes with language models alongside labs and vitals, and writes a daily risk score into the care team's workflow. Screens for malnutrition and delirium.

Builds a cuffless blood pressure wearable that estimates pressure from optical signals at the wrist, calibrated by a connected upper-arm cuff. Sold as a membership with a band, an app and the cuff.

Remote monitoring platform that pulls data from cardiac implants made by different manufacturers into one system and flags the patients who need attention. Two of its algorithms are FDA-cleared Class II software.

Runs a cloud platform for computational modeling and in silico trials, including credibility assessment of models and FDA-ready documentation. Joined the ARPA-H CIRCLE team in September 2026 to build validation infrastructure for critical illness digital twins.

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.

Remote prenatal and postpartum monitoring. The M•care System uses the M•wrap wearable and abdominal electrodes to capture fetal and maternal heart rate at home and send it to clinicians.

Israeli software startup whose CPETWise platform automates analysis, interpretation and reporting of cardiopulmonary exercise tests. FDA cleared CPETWise under K260242 on August 20, 2026, 206 days after receiving the traditional 510(k).

Builds software based therapeutics delivered through healthcare providers for gastrointestinal conditions such as irritable bowel syndrome.

Combines physiologic sensor data with electronic health record data to predict and prevent hospital-acquired pressure injuries.

Builds Quicktome, software that turns MRI and resting state functional MRI into patient specific maps of brain networks for surgical planning and deep brain stimulation.

Builds Connexus, a fully implanted intracortical brain-computer interface that records single-neuron activity across hundreds of channels and sends it wirelessly through intact skin.

Builds PMcardio, an ECG interpretation platform whose Queen of Hearts model reads 12-lead ECGs for heart attack patterns. FDA granted it a De Novo under DEN250044 in September 2026.

Builds the Layer 7 Cortical Interface, a thin-film electrode array that rests on the surface of the brain instead of penetrating it, so people with paralysis can control digital devices. Owns a MEMS fab in Texas that makes the arrays.

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.

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.

Consumer smart ring that tracks sleep, activity, stress and recovery, with FDA-cleared non-invasive blood oxygen measurement added in October 2026.

Makes the Accuro handheld ultrasound system for spinal anesthesia guidance and SpineNav-AI, machine learning software that identifies lumbar spine structures and the spine midline in ultrasound images.

Building phone based monitoring and management for heart rhythm medications, founded by electrophysiologist and bioengineer Rachita Navara.

A conformity assessment body for software and AI medical devices. It is designated as a notified body under EU MDR, an approved body for the UK MHRA, and a third party review organization recognized by FDA, and sells review and surveillance as a subscription.

Software-only cancer imaging company that combines biophysical modeling and machine learning. Its products are TumorSight Viz, TumorSight RISK and the research tool PhenoScope.

Cloud-native radiology platform that combines PACS, diagnostic viewing, reporting and worklist in a single system. Also sells Sirona Cortex, an agentic AI layer for radiology workflow.

Builds DERM, an AI tool that triages suspected skin cancer referrals from lesion images. It is used across NHS dermatology pathways in the UK.

Sells an AI assistant for clinical documentation, coding and decision support to European care providers. Three of its products hold Class IIa certification under the EU Medical Device Regulation.

AI guidance software that walks a clinician without sonography training through a cardiac ultrasound exam. Sold as the EchoSystem platform.

UpDoc makes prescription software that collects diabetes data from patients through a voice and chat agent. It issues insulin dosing instructions within parameters set by the prescriber.

Berlin AI company whose software reads screening mammograms inside Germany's national breast cancer screening program. In September 2026 it received CE certification for a Class IIb autonomous triage function that reports clearly normal exams without a radiologist.

vMap reads a standard 12-lead ECG and localizes arrhythmia sources before an ablation procedure. Cleared for seven arrhythmias and two pacing types.

Builds AI software that detects suspected disease on medical images and physiological data and routes the case to a specialist. Its Viz HCM device led FDA to create a new Class II regulation for cardiovascular machine learning notification software.

Runs the Spire remote patient monitoring system with wearable Health Tags for continuous cardiopulmonary tracking, aimed at catching COPD deterioration before symptoms appear.

Samsung SDS spinoff selling the S-Patch wearable ECG monitors and cloud analysis software, including the S-Patch CardioAI arrhythmia analysis software licensed to monitoring providers and testing facilities.

Device-agnostic ECG analysis software that turns Holter and wearable patch recordings into beat and rhythm reports, including atrial fibrillation detection.