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THE TAPE
Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register
The Directory // Imaging & Radiology

Imaging & Radiology

Ultrasound, MRI, CT, optical imaging and image analysis. 15 companies listed.

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.

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.

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.

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.

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.

Bengaluru, India  ·  Est. 2017  ·  Unknown

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

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.

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.

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.

Kitchener, ON, Canada  ·  Est. 2016  ·  Series A  ·  510(k) cleared

Makes a very small forward looking camera on a catheter for imaging inside blood vessels during neurovascular procedures.

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