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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 // Cardiovascular

Cardiovascular

Structural heart, electrophysiology, vascular access and cardiac monitoring. 26 companies listed.

Los Gatos, CA  ·  Series C  ·  $113M raised  ·  Submission pending

Akura Medical is developing the Katana saline-jet thrombectomy system for pulmonary embolism, now in the QUADRA-PE trial under an FDA IDE.

Waltham, MA  ·  Acquired  ·  Submission pending

Develops Pulse IVL, an intravascular lithotripsy system that uses pulsed pressure waves generated from carbon dioxide inside a balloon catheter to fracture calcium in arteries.

Cardiff by the Sea, CA  ·  Acquired  ·  510(k) cleared

Makes the Hotwire radiofrequency guidewire, which crosses the atrial septum and then serves as the working wire for left heart procedures such as atrial fibrillation ablation. Johnson and Johnson agreed to acquire the company in April 2026.

Petah Tikva, Israel  ·  Series B  ·  510(k) cleared

Biobeat makes a chest-worn patch that measures blood pressure and other vitals without a cuff, cleared for 24-hour ambulatory monitoring.

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.

Chicago, IL  ·  Series A  ·  De Novo granted

Builds a chest-worn cardiac sensor and AI software that noninvasively estimate hemodynamic pressures for heart failure management.

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.

Houston, TX  ·  Est. 2021  ·  Unknown

Developing a catheter that performs targeted nerve ablation in the upper abdomen to treat chronic heart failure, with a probe designed to limit damage to surrounding tissue.

Brentwood, TN  ·  Unknown  ·  PMA approved

Develops bioabsorbable vascular closure devices for femoral arterial access sites after catheter procedures.

Menlo Park, CA  ·  Est. 2019  ·  Series C  ·  510(k) cleared

Makes the Hēlo Thrombectomy System, a catheter that combines aspiration with mechanical clot disruption for venous thromboembolism. Cleared under K252956 in December 2025.

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.

Herzliya, Israel  ·  Acquired  ·  PMA approved

Developed the NEXUS off-the-shelf stent graft for endovascular repair of the aortic arch. Distributed in Europe by Artivion, which held an option to acquire the company on FDA approval.

Toronto, ON, Canada  ·  Unknown

Makes HeartWatch, a wearable for continuous at home heart monitoring with an emergency contact function.

Menlo Park, CA  ·  Est. 2020  ·  Series C  ·  $115M+ raised  ·  510(k) cleared

Inquis Medical makes the Aventus aspiration thrombectomy system with blood reinfusion and tissue sensing for deep vein thrombosis and pulmonary embolism.

Irvine, CA  ·  Est. 2006  ·  Growth  ·  PMA approved

Develops the Trilogy transcatheter heart valve, approved in the U.S. in 2026 for severe aortic regurgitation. Backed by Bain Capital Life Sciences, Andera Partners and Valiance.

Menlo Park, CA  ·  Est. 2024  ·  Series B  ·  510(k) cleared

Jupiter Endovascular builds the Vertex catheter system, which uses pressurized transforming fixation to hold position in the pulmonary arteries for clot removal.

Burnaby, BC, Canada  ·  Est. 2007  ·  Growth  ·  PMA approved

Makes the Globe Pulsed Field System for atrial fibrillation ablation. Its catheter carries 122 individually selectable electrodes, so mapping and ablation run from the same device.

Marietta, GA  ·  Est. 2016  ·  Growth  ·  510(k) cleared

Builds spine and orthopedic implants from molybdenum-rhenium alloys, with 24 510(k) clearances, and is developing SIEGEL, a nickel-free balloon-expandable TAVR valve in the STAR trial. Boston Scientific owns about 34% after a $1.5B investment in May 2026.

Aliso Viejo, CA  ·  Est. 2017  ·  Growth  ·  510(k) cleared

Okami Medical makes the LOBO braided vascular occluder and Sendero delivery catheters for peripheral embolization.

Galway, Ireland  ·  Series A  ·  €44.5M raised  ·  510(k) cleared

Makes aspiration and access catheters for mechanical thrombectomy in ischemic stroke, including the 0.088-inch Millipede88.

Newport Beach, CA  ·  Est. 2019  ·  Series D+  ·  PMA approved

Makes the Minima Stent System, a balloon-expandable growth stent for pulmonary artery stenosis and coarctation of the aorta in neonates and infants. Approved under PMA P240003 in August 2024.

San Francisco, CA  ·  Est. 2021  ·  Unknown

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

Paris, France  ·  Unknown  ·  Submission pending

Developing a pressure driven perfusion system that holds vascular pressure during procedures that obstruct blood flow, aimed at acute limb ischemia. Built inside Sofinnova's MD Start accelerator.

Irvine, CA  ·  Est. 2019  ·  Unknown

Makes an adhesive sensor that monitors blood pressure continuously, validated first in operating room settings.

Houston, TX  ·  Est. 2017  ·  Series A  ·  Breakthrough designation

Makes a bioabsorbable wrap placed around a blood vessel during dialysis access and bypass surgery to reduce the chance the connection fails.

Costa Mesa, CA  ·  Est. 2025  ·  Seed  ·  In development

inQB8 Medical Technologies spinout developing TVARC, a transcatheter valved aortic root conduit for aortic root and ascending aortic disease. Preparing for first-in-human use.

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