Cardiology in Minnesota

Saluda Medical is a global neuromodulation company headquartered in Bloomington, Minnesota, specializing in advanced spinal cord stimulation (SCS) therapies for chronic pain management. The company's flagship product, the Evoke® System, is the first FDA-indicated closed-loop SCS system that directly senses and measures the spinal cord's physiologic response using Evoked Compound Action Potentials (ECAPs), enabling real-time adjustment of stimulation parameters for optimal therapeutic efficacy. Founded in 2011, Saluda Medical has developed over 15 years of research and clinical experience, with published clinical evidence demonstrating long-term pain relief outcomes extending to 36 months. The company operates across North America, Australia, the United Kingdom, and the Netherlands, serving clinicians and patients seeking alternatives to opioid-based pain management for chronic intractable pain conditions affecting over 540 million people globally.

Forj Medical is a global contract design and manufacturing organization (CDMO) specializing in advanced medical device development and high-volume manufacturing. The company operates 450,000+ square feet of manufacturing space across six global facilities (U.S., Costa Rica, Singapore, Indonesia) and assembles 250+ million devices and components annually. Core competencies include electromagnetic sensors and navigation systems, surgical energy systems, fluid and gas management solutions, optical systems, stimulation and active wearables, and consumables and components. Forj Medical provides end-to-end services from concept and full medical device system development through commercialization, including custom electromechanical system design, design for manufacturing (DFM), design for automation and scale, custom prototyping, and process and test development. Manufacturing capabilities are vertically integrated, encompassing PCBA manufacturing, precision molding, cable assembly, cleanroom operations, polymer and metal 3D printing, and automation. The company maintains ISO 13485 certification and holds five FDA Establishment Registrations. Quality management systems include robust QMS, traceability protocols, risk management, and audit readiness. Supply chain and operational services include supply chain management, service and maintenance, sustaining engineering, packaging and shipping, and international logistics. Clients span Fortune 500 medical device manufacturers and emerging medtech companies. The organization combines 4+ million combined hours of medical device engineering expertise across its portfolio.

Waters Medical Systems is a transplant technology company specializing in organ preservation and perfusion systems. The company manufactures the RM4® platform, a hypothermic oxygenated machine perfusion system designed to improve kidney transplant outcomes by maintaining organ viability for up to 24 hours. The RM4® features pulsatile pressure delivery mimicking physiological cardiac waveforms, active in-cassette oxygenation, dual-kidney capacity, and WiFi-enabled remote monitoring via the IGL-App. Waters also produces preservation solutions: the IGL® Pulsatile Perfusion Solution for machine perfusion of kidneys, IGL® Cold Storage Solution for kidney, liver, and pancreas preservation, and Celsior® cold storage solution for heart preservation. The IGL-App provides secure cloud-connected remote monitoring of critical perfusion parameters including flow rate, pressure, temperature, and time, enabling transplant teams to maintain oversight during organ transport and preparation. The company serves transplant centers globally with clinically validated technologies supported by peer-reviewed research demonstrating improved graft survival rates and reduced adverse events, particularly in donation after circulatory death (DCD) cases. Waters Medical Systems positions itself as a trusted partner in advanced transplantation technology with decades of research and clinical experience.

BioMedix (Collaborative Care Diagnostics, LLC) is a vascular diagnostics company founded in 2004 specializing in non-invasive physiologic assessment systems for identifying peripheral artery disease (PAD) and managing population health in value-based care settings. The company's primary product line includes PADnet, a flexible and customizable vascular assessment system designed for clinical settings to detect hidden peripheral vascular disease through non-invasive testing, and PADnet Xpress, a portable, rapid screening solution optimized for population health management. BioMedix Xchange is a population health management platform that aggregates test results and patient history for centralized analysis and specialist review. The company enables secure remote transmission of test data and patient information to specialists for interpretation, supporting distributed care models and reducing patient travel burden. PADnet systems are used by podiatrists, primary care physicians, vascular surgeons, cardiologists, and interventional specialists across physician practices, hospitals, and health systems. Products integrate with multi-specialty groups to streamline workflow and improve care coordination between primary physicians and specialists. The company emphasizes training and support for clinical staff to ensure proper testing protocols and diagnostic confidence. Applications include screening high-risk populations (diabetics, smokers, patients over 65), evaluation of intermittent claudication and limb pain, identification of candidates for revascularization procedures, and ongoing management of vascular disease in value-based payment models. The platform supports seamless sharing of diagnostic results across care networks and remote specialist interpretation via secure internet-based systems.

Fasikl Inc. is a neurotechnology company developing AI-based therapeutic devices for neurological conditions. The company's flagship product, Felix NeuroAI™ Wristband, is a non-invasive wearable device that has received FDA clearance for the treatment of essential tremor. Felix operates through advanced AI technologies that decode and modulate neural signals, delivering all-day symptomatic relief without surgery or medication. The device represents a breakthrough in AI therapeutics, combining cloud-based artificial intelligence with real-time neural signal processing. Fasikl also develops the Fasikl-X™ Nerve-Computer Interface platform for broader neural interfacing applications. The company has invested over 20 years of R&D in neural signal processing and AI-driven treatment modalities. Products are designed for direct patient use and clinical settings, with support for both individual patients and healthcare providers. FDA clearance indicates regulatory approval for the Felix device as a Class II or higher medical device. The company targets essential tremor patients and related neurological indications, positioning itself at the intersection of wearable medical devices, neurotechnology, and artificial intelligence therapeutics.

ThermaSolutions LLC is a global leader in hyperthermic cancer treatment systems, headquartered in White Bear Lake, Minnesota. The company manufactures and distributes the ThermoChem HT series (HT-2000 and HT-2500) of integrated hyperthermic intraperitoneal chemotherapy (HIPEC) devices for adjunctive surgical oncology. These systems heat and circulate perfusate solutions to therapeutic temperatures (42–43°C) within the intraperitoneal cavity during cytoreductive surgery for peritoneal surface malignancies, including pseudomyxoma peritonei and ovarian cancer. ThermaSolutions also offers the HurriChem device line—FDA-approved (HurriChem Device Kit for laparoscopic irrigation) and CE-marked (HurriChem Nebulizer for pressurized intraperitoneal chemotherapy/PIPAC)—which aerosolizes fluids for delivery via minimally invasive ports during laparoscopic procedures. Additional product offerings include disposable HIPEC procedure kits, whole-body hyperthermia systems (HEATT, in partnership with Verthermia), isolated limb perfusion products, the SurgiChem Dual Injector Pump, thermal insulators, lasso tubing drains, and chemo waste management products. The company maintains FDA 510(k) clearance for select devices and CE marking for international markets. ThermaSolutions provides comprehensive training, clinical support, and educational resources through the HIPEC Program Support initiative and partnerships with oncology organizations. Founded in 1999, the company operates a US headquarters in White Bear Lake, MN, and an international office in Breda, The Netherlands, serving hospitals and surgical centers globally through a distributor network.

MeKo Manufacturing e.K. is a contract manufacturer of precision medical components and implants for the interventional and surgical device industry. Founded in 1995, the company pioneered stent manufacturing and is now among the largest contract manufacturers of medical components globally. MeKo specializes in laser cutting, laser welding, and advanced processing of materials including stainless steel (316L, 316LVM), cobalt alloys (L605, Phynox, MP35N), nitinol (NiTi), magnesium alloys (Resoloy®), nickel-free alloys (Vasculoy®), and polymers (PolyMediX®, PLLA, PGA). The company manufactures implants for cardiology, neurology, radiology, ophthalmology, and urology applications, with product lines including metal stents, NiTi stents, hypotubes, retrieval baskets, bone nails, heart valve frames, orthopedic devices, surgical instruments, microcomponents, and drug-delivery balloon catheters. Manufacturing capabilities include CAD/CAM design, precise laser cutting (tolerances below ±5 μm), laser welding, mechanical processing, heat treatment, shape setting, electropolishing, 3D metal printing, polymer coating, marker crimping, and rapid prototyping. The company operates ISO-certified quality management with 100% visual inspection using over 100 specialized high-end microscopes and maintains ISO 8 cleanrooms (Class 100,000). MeKo offers finite element analysis (FEA) simulation services, prototype-to-series production capabilities, and operates 24/7 manufacturing. The company maintains facilities in Germany (Sarstedt, near Hannover), the USA (Bloomington, Minnesota), California, and Costa Rica.

Ergotron Inc. is a manufacturer of ergonomic healthcare and workspace solutions with over 40 years of operational history. The company specializes in mobile medical carts, monitor mounts, standing desks, workstations, and charging systems designed for healthcare facilities, offices, educational institutions, and industrial environments. Key product lines include the Mosaic ultra-configurable workstation with RhythmConnect fleet management software, the CareFit Combo modular care cart, and the StyleView medical cart line. Ergotron offers specialized telemedicine carts, light-duty and full-featured medical workstations, and procedure-specific cart configurations. The company manufactures monitor mounting systems (desk, wall, and multi-monitor configurations), charging cabinets and carts for Chromebooks, iPads, laptops, and tablets, and standing desk solutions. Products serve healthcare delivery, clinical workstations, medication management, and point-of-care computing environments. The company maintains a global presence with participation in major medical and healthcare trade shows (DMEA, EXPOSANITA, SAMTIT, HKTDC Medical Fair, Digital Health Festival). Ergotron's design philosophy emphasizes human-centered ergonomics and movement-enabled workspaces to reduce caregiver strain and improve workflow efficiency in clinical settings. The company provides workspace assessment tools, ergonomic planning resources, and integrated fleet management capabilities through RhythmConnect for healthcare IT asset management.

Corvascular Diagnostics, LLC manufactures the VasoGuard® Peripheral Vascular Testing System, a comprehensive family of diagnostic devices for non-invasive vascular assessment. The product line includes five modular configurations (V2, V4, V6, V8, V10) designed to support varying clinical testing protocols, from basic screening to advanced multi-parameter diagnostics. Each system integrates pressure channel monitoring (2–10 channels), photoplethysmography (PPG) probes (2–5 units), and Doppler ultrasound capabilities (8 MHz and/or 4 MHz), coupled with medical-grade touchscreen interfaces and height-adjustable carts. All units are manufactured in the USA with on-site support and service. The company provides a 5-year bumper-to-bumper warranty and optional accidental damage coverage (ADC), with on-site training included as standard. The VasoGuard line serves peripheral vascular diagnostic needs in hospital systems, vascular labs, and outpatient clinics. Hardware upgradability between models allows clinical facilities to expand testing capacity. The company emphasizes clinical accuracy, state-of-the-art pressure monitoring, and Doppler envelope technology for reliable patient assessment.

Medica USA Inc. is a vertically integrated biomedical manufacturer and technology developer based in Eden Prairie, Minnesota, with parent company operations in Mirandola, Italy since 1985. The company specializes in blood purification devices and systems, including dialysis, continuous renal replacement therapy (CRRT), and apheresis equipment and disposables. Core competencies span electromedical device design, hollow-fiber membrane technology, and disposable medical device manufacturing. Beyond renal care, Medica serves cardiology, surgical oncology, organ transplantation, urology, and gastroenterology diagnostic markets. The company operates three integrated business units: Medical (blood purification products and devices), Water Purification (industrial and hospital water treatment systems using proprietary membrane technology), and Turnkey Solutions (complete system integration and industrial automation for the biomedical sector). Medica maintains in-house R&D, manufacturing, quality assurance, regulatory affairs, sales, and after-sales service. The company holds an extensive portfolio of proprietary patents and is ISO-certified for medical device production. All products are manufactured under strict compliance with regulatory requirements for US, European, and international markets.

Radux Devices Inc. is a Minnesota-based medical device manufacturer specializing in occupational health and safety solutions for interventional healthcare professionals. The company designs ergonomic tools and radiation protection devices for interventional cardiologists, radiologists, vascular medicine specialists, electrophysiologists, and pain management practitioners. Founded by Dr. Greg Gordon, Radux focuses on reducing scatter radiation exposure and musculoskeletal fatigue through innovative shielding and arm-support systems. Their product line addresses the critical gap between patient care and provider safety, offering cost-effective solutions that improve workflow efficiency and practitioner well-being across multiple medical disciplines including interventional cardiology, radiology, vascular medicine, electrophysiology, orthopedics, neurovascular procedures, and pain management.

Pleural Dynamics is a Minneapolis-based medical device innovator specializing in minimally invasive solutions for chronic fluid collections within the body. The company's flagship product, ACES (Automatic Continuous Effusion Shunt), is an FDA-cleared implantable device designed to treat chronic recurrent pleural effusions—excess fluid accumulation between the lung and chest wall that causes severe dyspnea, cough, and reduced quality of life. ACES leverages the body's natural breathing motion to automatically and continuously transfer pleural fluid into the abdomen for reabsorption, eliminating the need for repeated drainage procedures, external catheters, or prolonged hospitalization. With a 1-day or less hospital stay, zero 30-day failure rate, and zero pleural infection rate in clinical trials, ACES offers superior clinical outcomes and cost-effectiveness compared to traditional pleurodesis and indwelling pleural catheter approaches. The device targets the approximately 660,000 new patients annually in the US and Europe with recurrent pleural effusions, representing a $1.5B annual market opportunity. Pleural Dynamics addresses a significant clinical unmet need by providing sustained symptom relief while reducing infection risk, caregiver burden, and overall healthcare costs.

Pharaoh Neuro, Inc. develops the Neurapheresis™ platform, an investigational extracorporeal cerebrospinal fluid (CSF) filtration therapy designed to remove foreign constituents, pathogens, and blood degradation products from the CSF in neurocritical patients. The company, founded in 2017 as a collaboration between Minnetronix Neuro and Duke University Medical Center, focuses on restoring CSF balance to protect brain health and improve outcomes in patients with acute neurological conditions. Current clinical initiatives include subarachnoid hemorrhage (SAH), cryptococcal meningitis, and leptomeningeal carcinomatosis. The Neurapheresis™ system operates via spinal catheter extension, offering precision management of intracranial pressure and metabolic waste clearance in the neurocritical care setting. The device is currently in clinical investigation under FDA Investigational Device Exemption (IDE) and has not yet received FDA clearance or approval for commercial distribution in the United States.

Hemostasis, LLC is a FDA-registered, ISO 13485:2016-certified medical device manufacturer specializing in advanced biomaterial-based hemostasis and wound-healing technologies. The company develops and manufactures innovative bleeding-control products utilizing pharmaceutical-grade NOCC chitosan polymer technology. Core offerings include PosiSep® branded hemostat dressings and intranasal splints for ENT sinus procedures, NexStat® and Accel® topical hemostatic powders, BleedArrest® foam sponges, BoneSeal® bone hemostats, and NexFoam® topical hemostat sponges. Products are designed for diverse surgical applications including sinus, cardiac, orthopedic, vascular, soft tissue, and solid organ procedures. The company provides custom manufacturing services for OEMs and maintains active research and development capabilities in bleeding control technologies.

NorthStar Surgical, Inc. is a specialty surgical products distributor and manufacturer's representative group serving the Upper Midwest, including Minnesota, North Dakota, South Dakota, Wisconsin, Iowa, and Nebraska. The company provides surgical products and solutions across multiple surgical specialties: Cardiac, ENT (Otorhinolaryngology), General Surgery, Gynecological, Neurosurgery, Orthopedic, Plastic Surgery, Vascular, and Urological Surgery. NorthStar's sales force brings over 100 years of combined experience in specialty surgical product sales and distribution. The company operates as both a direct distributor and rep group, positioning itself as a regional leader in the specialty surgical market. Based in Edina, Minnesota, NorthStar serves hospitals, surgical centers, and physician practices throughout the region. The company maintains direct sales support, customer service, and operations management to facilitate orders, technical support, and relationship management with healthcare facilities.