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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 // Imaging & Radiology

Imaging & Radiology

Ultrasound, MRI, CT, optical imaging and image analysis. 49 companies listed.

Halifax, Nova Scotia  ·  Est. 2012  ·  Series C  ·  In development

Clinical-stage developer of Eye90 microspheres, an yttrium-90 radioembolization device made from a glass composition that stays visible during the procedure. Indicated work targets benign and malignant hypervascular tumors, including liver cancer.

San Francisco, CA  ·  Est. 2023  ·  Seed  ·  In development

Redesigned MRI hardware for mobile cancer screening and runs the scanners itself as trailer-based imaging clinics billed per scan, starting with prostate imaging before biopsy.

Tel Aviv, Israel  ·  Est. 2016  ·  Series D+  ·  $500M+ raised  ·  510(k) cleared

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.

Seoul, South Korea  ·  Est. 2018  ·  Series B  ·  510(k) cleared

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.

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.

Chicago, IL  ·  Est. 2014  ·  Series D+  ·  $148M raised  ·  510(k) cleared

Builds xvision, an augmented reality navigation system for spine surgery that projects CT anatomy onto a headset the surgeon wears. Its second generation X2 headset was cleared in 2025.

Suzhou, China  ·  Series B  ·  Not a regulated device

Develops ophthalmic imaging hardware and AI diagnostic software, including the MIAS-3000 OCT analysis system cleared as a Class III device in China.

San Francisco, CA  ·  Est. 2019  ·  Series B  ·  $55M raised  ·  510(k) cleared

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.

Oxford, UK  ·  Est. 2018  ·  Series A  ·  De Novo granted

Develops AI software that quantifies coronary inflammation and plaque from coronary CT angiography to predict cardiac risk. University of Oxford spinout with a U.S. office in Stamford, Connecticut.

Boston, MA  ·  Series B  ·  $43M raised  ·  De Novo granted

Sells Clairity Breast, FDA-authorized software that estimates a woman's five-year breast cancer risk from an existing screening mammogram. Now also offered directly to patients through Everlywell.

Est. 2024  ·  Acquired  ·  Breakthrough designation

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

Toronto, Canada  ·  Public  ·  510(k) cleared

The Novasight Hybrid system images coronary arteries with intravascular ultrasound and optical coherence tomography at the same time, co-registered in one pullback.

Natick, MA  ·  Est. 2014  ·  Unknown

Curadel Surgical Innovations develops near-infrared fluorescent contrast agents for image-guided surgery, led by ZW800-1 for visualizing the ureters during abdominal and pelvic procedures.

Bothell, WA  ·  Seed  ·  $8M+ raised  ·  In development

Remote robotic ultrasound platform that lets a sonographer run a diagnostic imaging exam on a patient in another location.

Grenoble, France  ·  Est. 2009  ·  Acquired  ·  510(k) cleared

Builds the Op.n surgical platform, which combines 2D and 3D imaging, navigation and robotic guidance for spine and orthopedic procedures, and is open to third party implants and applications. Enovis agreed to acquire the company in September 2026.

Boston, MA  ·  Est. 2013  ·  Series D+  ·  $185M raised  ·  510(k) cleared

Builds PlaqueIQ, FDA-cleared software that quantifies plaque composition from coronary CT angiography, and a BioIntegrated FFR-CT product under FDA review.

Chengdu, China  ·  Est. 2025  ·  Seed  ·  Not a regulated device

Works on ultrasound based brain computer interfaces, neuromodulation and functional ultrasound imaging, all without an implant. Registered in September 2025 and announced its launch in January 2026.

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.

Minneapolis, MN  ·  Growth  ·  De Novo granted

HistoSonics makes the Edison histotripsy system, which uses focused ultrasound to destroy liver tumors without incisions, heat or radiation.

London, UK  ·  Est. 2021  ·  Series A  ·  510(k) cleared

King's College London spinout selling HyperSnap, a hyperspectral imaging system that shows tissue oxygenation and composition during surgery. Cleared under K250268 in June 2025 with product code SFE.

Los Angeles, CA  ·  Est. 2021  ·  Unknown

Makes Skylight, a system that projects medical images onto the patient during procedures so surgeons do not use a headset or look away at a monitor. Aimed at spine surgery, pain management and interventional radiology.

San Francisco, CA  ·  Est. 2016  ·  Unknown

Makes a compact automated scanner that captures a 3D ultrasound volume of the breast in about a minute, with machine learning applied to flag abnormal masses.

Shenzhen, China  ·  Est. 2019  ·  Series B

Krinwave builds the kOS ultrasound imaging platform for deep tissue imaging in neurology, abdominal and cardiovascular exams.

Dublin, Ireland  ·  Est. 2017  ·  Unknown  ·  510(k) cleared

Builds VERAFEYE, a catheter-based cardiac imaging and navigation platform that produces 2D, 3D and 4D views of the heart and tracks imaging and ablation catheters during electrophysiology procedures.

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.

San Mateo, CA  ·  Est. 2020  ·  Series B  ·  $73M Series B raised  ·  510(k) cleared

Builds Focalist, a handheld robotic system that guides needle placement using real-time ultrasound. Used for vascular access, regional nerve blocks and organ access.

Brooklyn, NY  ·  Unknown  ·  510(k) cleared

Software that denoises and sharpens MRI and PET images using random matrix theory and MR-guided reconstruction. A spinout of NYU Langone Health.

Bengaluru, India  ·  Est. 2017  ·  Unknown

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

Claymont, DE  ·  Unknown  ·  510(k) cleared

Makes NextMR, software that generates 3D bone visualization of the lumbar spine and sacrum from a standard diagnostic MRI, removing the need for a separate CT scan.

Utrecht, Netherlands  ·  Unknown  ·  510(k) cleared

BoneMRI software builds a CT-like 3D view of bone from an MRI scan, so bone structures can be read and surgical plans made without the radiation dose. A University of Utrecht spin-off.

Austin, TX  ·  Est. 2022  ·  Unknown

Handheld imaging device using frequency domain near infrared spectroscopy to indicate within a week of starting treatment whether a breast cancer therapy is working.

Salt Lake City, UT  ·  Est. 2012  ·  Unknown  ·  510(k) cleared

Builds the nView s1, a low-dose 3D imaging and surgical guidance system that uses the patient's own anatomy as the navigation map, with pediatric surgery as its focus.

Sydney, Australia  ·  Est. 2019  ·  Series B  ·  510(k) cleared

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.

Bloomington, IL  ·  510(k) cleared

Makes the Inova 1 towerless hybrid endoscope system, which puts the camera, light source and display in the scope instead of a cart.

Toronto, ON  ·  Est. 2013  ·  Public  ·  PMA approved

Builds optical coherence tomography systems with AI detection for assessing surgical margins during cancer surgery. Listed on the TSX Venture Exchange as PINK.

Oakland, CA  ·  Est. 2016  ·  Growth  ·  $99M raised  ·  510(k) cleared

Makes a single-sided point-of-care MRI system for prostate procedures, cleared for MRI-guided prostate biopsy, with AI planning and robotic needle guidance still in development.

Omer, Israel  ·  Est. 2014  ·  Public  ·  De Novo granted

Pulsenmore makes a smartphone cradle that lets pregnant women perform ultrasound scans at home for remote reading by clinicians. It is listed on the Tel Aviv Stock Exchange.

Charlottesville, VA  ·  Est. 2011  ·  Unknown  ·  510(k) cleared

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.

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.

Bristol, United Kingdom  ·  Est. 2020  ·  Seed  ·  £470K equity plus an £8.4M Innovate UK contract raised  ·  In development

Builds handheld optical coherence tomography systems on a photonic chip, for retinal disease monitoring in clinics and at home.

Chicago, IL  ·  Est. 2017  ·  Unknown  ·  510(k) cleared

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

San Francisco, CA  ·  Series D+  ·  $150M raised  ·  510(k) cleared

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.

London, UK  ·  Est. 2012  ·  Unknown  ·  CE mark

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

Palo Alto, CA  ·  Series A  ·  Breakthrough designation

Develops a high intensity focused ultrasound system for non invasive treatment of pancreatic cancer, with real time guidance, cavitation bubble visualization and robot assisted positioning.

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.

Cambridge, MA  ·  Series B  ·  510(k) cleared

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

Berlin, Germany  ·  Est. 2018  ·  Series A  ·  CE mark

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.

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.

San Francisco, CA  ·  Series D+  ·  De Novo granted

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.

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