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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 // Cardiovascular

Cardiovascular

Structural heart, electrophysiology, vascular access and cardiac monitoring. 85 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.

Shenzhen, China  ·  Est. 2020  ·  Series A  ·  Not a regulated device

Develops and sells robots for vascular interventional surgery, covering cardiovascular, cerebrovascular, peripheral vascular and tumor intervention. Building a next generation pan-vascular system.

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.

Marin, CA  ·  Est. 2015  ·  Unknown  ·  Submission pending

Builds funnel catheters used alongside stent retrievers during thrombectomy for large vessel occlusion stroke. Its ANA Funnel Catheter is in the 327-subject ATHENA IDE trial in the US.

Birmingham, AL  ·  Series A  ·  $2.2M raised  ·  In development

Developing Barostent, a catheter-delivered implant placed in the aortic arch to induce the baroreflex. The target is severe hypertension that drugs and renal denervation have not controlled.

Boston, MA  ·  Unknown  ·  In development

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.

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.

Chicago, IL  ·  Acquired  ·  De Novo granted

Makes ensoETM, a device that regulates esophageal temperature to protect the esophagus during cardiac ablation. Acquired by Haemonetics, and its De Novo grant became 21 CFR 870.5720 in September 2026.

The Woodlands, TX  ·  Est. 2014  ·  Public

A catheter with a microchip sensing array that detects individual nerve signals from inside a blood vessel, ablates the overactive ones and checks the result during the procedure. First clinical work is in pancreatic cancer pain.

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.

Carlsbad, CA  ·  Est. 2019  ·  Acquired  ·  510(k) cleared

Laser-based intravascular lithotripsy. The SEISMIQ system generates acoustic pressure waves inside a balloon catheter to fracture calcium in coronary and peripheral arteries.

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.

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.

Santa Cruz, CA  ·  Est. 2020  ·  Series C  ·  In development

Pairs catheter delivered heart valve implants with a robotic platform for minimally invasive structural heart procedures. Its devices are for clinical investigation only.

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.

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.

Burlington, MA  ·  Est. 2016  ·  Series C  ·  $70.5M raised  ·  In development

Builds a high density electrical mapping platform that looks for the cardiac sites driving atrial fibrillation, so electrophysiologists can target them during ablation.

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.

Cantu, Italy  ·  Est. 2020  ·  Series A  ·  In development

Builds arteriovenous grafts for hemodialysis vascular access from Silkothane, an electrospun blend of silk fibroin and polyurethane. Its first graft is in a first-in-human study at four Italian centers.

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.

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.

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.

Santa Cruz, CA  ·  Series D+  ·  $55M+ raised  ·  510(k) cleared

Makes the Emboliner, a dual-layer filter placed in the aorta to capture embolic debris during transcatheter aortic valve replacement.

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.

Shanghai, China  ·  Est. 2023  ·  Series A  ·  $12M raised  ·  In development

Develops OpusOne, a percutaneous ventricular assist device designed to deliver higher flow from a smaller catheter profile. Running a registration trial in China.

Minneapolis, MN  ·  Unknown  ·  In development

Develops laser and electric intravascular lithotripsy systems for calcified artery disease. Its Sola coronary laser IVL system reported 96.4 percent procedural success in a 30-patient first-in-human study.

Cardiff-by-the-Sea, CA  ·  Series B  ·  Breakthrough designation

Building the FieldForce contact force focal pulsed field ablation catheter for ventricular tachycardia and atrial fibrillation. Founded by Farapulse founder Steven Mickelsen.

Enschede, Netherlands  ·  Pre-seed  ·  In development

Builds magnetic navigation technology that steers catheters through blood vessels. Spun out of the University of Twente.

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.

Toronto, ON, Canada  ·  Unknown

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

Paris, France  ·  Est. 2010  ·  Growth  ·  CE mark

Develops a two-component transcatheter mitral valve replacement system for patients with mitral regurgitation who are not surgical candidates. The system and its Clarity Valve carry CE marks granted in 2026.

Neuchatel, Switzerland  ·  Est. 2018  ·  Series B  ·  $119M raised  ·  510(k) cleared

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.

Paris, France  ·  Est. 2016  ·  Growth  ·  $63M raised  ·  510(k) cleared

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.

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.

Dallas, TX  ·  Unknown  ·  510(k) cleared

Makes the CLEAR aspiration platform, a pump and single-use catheter system that uses cyclical aspiration to remove clots. Cleared in the US for peripheral vessels and CE marked in the EU.

Galway, Ireland  ·  Est. 2018  ·  Seed  ·  $5.3M raised  ·  510(k) cleared

Makes the InVera Infusion Device, a 5Fr catheter with a helical coil that delivers sclerosants into diseased leg veins without heat. Spun out of the BioInnovate Ireland program and formerly named Venari Medical.

Santa Rosa, CA  ·  Est. 2026  ·  Unknown  ·  Submission pending

Formed in 2026 to take over the Laminar left atrial appendage program from Johnson & Johnson. The catheter-based device closes the appendage using rotational motion and leaves little implant material exposed in the left atrium.

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.

Paris, France  ·  Seed  ·  3 million euros raised  ·  In development

Mechanical thrombectomy for acute ischemic stroke, aimed at clot removal and revascularization. Still preclinical.

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.

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.

Yakum, Israel  ·  Est. 2024  ·  Pre-seed  ·  510(k) cleared

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).

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.

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.

Atlanta, GA  ·  Series A  ·  $20M raised  ·  In development

Developing the CARLEN transcatheter mitral valve repair system, a single-leaflet implant that restores coaptation in functional mitral regurgitation. First-in-human data came from centers in Georgia, Paraguay and Uzbekistan.

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.

Maple Grove, MN  ·  Unknown  ·  510(k) cleared

Makes linerless neurointerventional access catheters, including the NeuGlide and NeuFlex lines, for introducing devices into neuro, coronary and peripheral vasculature.

Est. 2020  ·  Seed  ·  De Novo granted

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.

Baltimore, MD  ·  Unknown  ·  510(k) cleared

Baltimore company developing a transseptal puncture device for left-heart access, cleared by FDA in April 2026.

Mountain View, CA  ·  Series B  ·  $87M raised  ·  In development

Develops the Magnitude drug-eluting bioresorbable scaffold for below-the-knee peripheral arterial disease, built from ultra-high molecular weight polylactic acid. The scaffold is in the ELITE-BTK trial under an FDA investigational device exemption.

Miami, FL  ·  Series B  ·  $58.5M raised  ·  In development

Builds a cyclic aspiration system for mechanical thrombectomy in acute ischemic stroke, running the TURBO IDE study toward a US submission.

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.

Or Yehuda, Israel  ·  Series B  ·  Breakthrough designation

Develops ContraBand, a minimally invasive transcatheter implant intended to rebalance hemodynamics in heart failure. Clinical stage, with European feasibility studies running and a US trial in preparation.

West Jordan, UT  ·  Growth  ·  510(k) cleared

Builds neurovascular access and aspiration catheters for ischemic stroke, including the FreeClimb and HiPoint reperfusion systems and the Tenzing delivery catheter.

Ohio  ·  Est. 2017  ·  Unknown  ·  De Novo granted

Makes esolution, a device that mechanically deviates the esophagus away from ablation energy during atrial fibrillation procedures. Its De Novo grant became 21 CFR 870.5710 in September 2026.

San Francisco, CA  ·  Est. 2021  ·  Unknown

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

Kaunas, Lithuania  ·  Unknown  ·  CE mark

Robotic platform for remote endovascular procedures, pairing a bedside unit that drives guidewires and catheters with a radiation-free control suite. Also sells Inflante, a digitally controlled indeflator for balloon inflation.

San Jose, CA  ·  Unknown  ·  510(k) cleared

Makes the IMPEDE family of embolization plugs, shape memory polymer devices that are crimped for catheter delivery and self expand when they contact blood.

Lake Forest, CA  ·  Unknown  ·  Breakthrough designation

Clinical-stage neurovascular company developing BosSTENT, a braided self-expanding stent for cerebral venous sinus stenosis, and the BosCATH support catheter used to deliver it.

Chapel Hill, NC  ·  Series A  ·  $6M raised  ·  In development

Developing SonoThrombectomy, an ultrasound and microbubble system for treating venous thromboembolism in a single catheter lab procedure.

Cambridge, MA  ·  Unknown  ·  In development

Developing patient-specific soft implants delivered through a catheter, work that started at MIT.

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.

Denver, CO  ·  Series B  ·  In development

Developing Point-Guard, a cerebral embolic protection device meant to cover all three cerebral vessels during transcatheter procedures such as TAVR. It is working toward an FDA investigational device exemption after a feasibility study in Australia.

Westminster, CO  ·  Est. 2009  ·  Public  ·  510(k) cleared

Makes pressure-enabled infusion catheters for liver and pancreatic embolization procedures in interventional radiology. Its cleared devices include the TriNav Infusion System, TriNav Infusion System LV, TriNav Advance and a pancreatic retrograde venous infusion system.

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.

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.

Santa Clara, CA  ·  Series B  ·  In development

Developing the A-FLUX Reducer System, a coronary sinus implant that narrows the vessel to raise myocardial perfusion in coronary microvascular dysfunction. The SERRA-I early feasibility study plans 30 subjects across six sites.

San Jose, CA  ·  Series B  ·  510(k) cleared

Physician-founded maker of the CrossFAST delivery system, which locks a monorail microcatheter to an outer delivery catheter so the pair advances as one unit in complex coronary intervention.

Brescia, Italy  ·  Est. 2021  ·  Unknown  ·  510(k) cleared

Builds VEnice, a handheld applicator that closes superficial and perforator veins with an implantable clip delivered through a 17-gauge needle under ultrasound guidance. No thermal energy or sclerosant.

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

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

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

Builds a miniature forward-looking camera for neurovascular and peripheral procedures, plus the Balloon Distal Access Catheter for stroke thrombectomy.

Irvine, CA  ·  Est. 2019  ·  Unknown

Makes a wearable sticker that measures blood pressure continuously, using a nanosensor developed at UC Irvine. Founded by Ray Liu, Michelle Khine and Josh Kim.

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.

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.

San Jose, CA  ·  Unknown  ·  Breakthrough designation

Developing a self-expanding stent and delivery system for venous sinus stenosis, aimed at pulsatile tinnitus. Founded by UCSF neurointerventional radiologist Matthew Amans.

Seoul, South Korea  ·  Est. 2019  ·  Unknown  ·  510(k) cleared

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.

Eindhoven, Netherlands  ·  Growth  ·  Submission pending

Makes aXess, a restorative vascular access conduit for hemodialysis that the body gradually replaces with its own tissue. Commercial in Europe since July 2026 and running a US pivotal trial.

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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