New Medical Devices
Step into the future of critical care with our curated collection of new medical devices and systems. Explore a dynamic showcase of the latest innovations, from novel ventilators and advanced patient monitoring systems to groundbreaking life support technologies like ECMO. Discover how these cutting-edge tools are revolutionizing patient care and improving outcomes in the ICU.
Did your ICU recently adopt a new medical device? We want to hear about it!
Accuracy Reimagined: The New Standard for Precision IV Infusion
The introduction of Plum Solo and Plum Duo marks the emergence of a new category in medical technology: the precision IV pump. Unlike traditional pumps that often suffer from delivery variability based on specific setups, these devices utilize unique cassette technology to ensure a ±3% accuracy rate in real-world clinical conditions. By eliminating the common inconsistencies of older systems, these pumps provide healthcare teams with predictable performance and, perhaps more importantly, reliable documentation that reflects exactly what the patient has received.
As modern patient care becomes increasingly data-driven, the ability to trust that infusion records perfectly match clinical delivery is vital. These precision pumps empower clinicians to make more informed decisions, knowing that the “Best in KLAS” technology behind the devices is bridging the gap between prescribed treatment and actual patient intake.
Brain Anesthesia Response Monitor (BARM) by Cortical Dynamics
BARM: The Future of Surgical Brain Monitoring and Anesthesia Precision
BARM is an innovative Australian technology that provides real-time measurement of both the patient’s unconsciousness and pain levels during surgery.
Core Function: It offers anesthesiologists precise data on brain activity, allowing them to optimize sedation and analgesia (pain relief).
Key Benefits:
Enhanced Patient Safety: Ensures patients receive the exact, appropriate level of sedation.
Reduced ICU Stays: Helps prevent over-sedation, which can potentially shorten mechanical ventilation times and overall ICU stays.
Improved Outcomes: Supports a stable surgical process, contributing to better patient stability and outcomes.
Significance: BARM is presented as a leap forward, setting a new standard for surgical monitoring by providing a crucial window into brain response during procedures.
VERAFEYE
Live 4D Ultrasound for Unmatched Interventional Cardiac Precision
Novel Platform: VERAFEYE is a new imaging platform specifically designed for interventional cardiac applications (electrophysiology and structural heart procedures).
End-to-End System: It is a complete system that integrates a catheter-based imaging tool within a software-defined platform, allowing it to adapt to specific clinical needs.
The Catheter: The VERAFEYE catheter is a novel, ultrasound-enabled device that provides an orbital view, capturing all surrounding anatomical structures with an unprecedented field of view.
Flexibility and Placement: The catheter can be placed freely within the heart chambers and vascular system, is compatible with standard introducer sheaths, and features direct steering to adapt to the patient’s specific anatomy.
Live 4D Imaging: The platform leverages computational power and a proprietary software engine to provide live 4D imaging (3D plus time) reconstructed at the speed of sound, offering intuitive and reliable navigation using Luma Vision’s proprietary ultrasound processing.
Virtual Incision
Despite the significant patient benefits of minimally invasive surgery (MIS)—including less pain, fewer complications, and faster recovery—an estimated 90% of U.S. operating rooms lack the necessary technology. To address this gap, Virtual Incision has developed MIRA (Miniaturized In Vivo Robotic Assistant), the first miniaturized surgical robotic system designed to make MIS more accessible.
The key advantage of MIRA is its portability and compact size. Unlike traditional, large robotic systems that require dedicated space, the MIRA robot weighs only approximately 2 pounds and can be used as a stand-alone device in smaller facilities or integrated into an existing setup. In February 2024, the company achieved a major milestone by receiving FDA approval to market MIRA for use in colectomies (colon removal), one of the most complex abdominal procedures, nearly half of which are still performed using older, open surgery techniques. MIRA aims to expand the reach of robotic MIS, making complex procedures safer and recovery faster for more patients.
HistoSonics
HistoSonics has pioneered a groundbreaking, non-invasive treatment platform called Edison, which utilizes histotripsy, focused ultrasound waves, to mechanically liquify and destroy targeted liver tumors at a sub-cellular level. This technology offers a vital new option for liver-cancer patients whose treatment choices were limited by the risk of traditional methods, like surgery or radiation, damaging healthy tissue. Histotripsy’s precision allows for significant accuracy in targeting diseased tissues.
Founded in 2009, HistoSonics received FDA clearance in October 2023 for the Edison system for liver tumor treatments. Clinical studies have demonstrated its effectiveness, showing it is 95.5% effective at treating tumors with a low complication rate of 6.8%. Adoption has been strong, with eight of the top ten U.S. cancer centers purchasing the device. Having secured a $102 million Series D funding round, HistoSonics is now expanding its research to investigate the use of the Edison system for treating tumors in the kidney, pancreas, thyroid, and breast.
BioButton
BioButton: Proactive, Seamless Continuous Patient Monitoring
The BioButton wearable device offers a comprehensive, scalable solution for continuous patient monitoring (CM), specifically designed to proactively collect and analyze leading indicators of patient decline both in clinical facilities and at home. This system continuously measures vital signs and biometrics, transmitting data via the patient-facing BioMobile app or a BioHub Cellular/Wi-Fi gateway.
By integrating BioButton monitoring workflows, organizations have the flexibility to adjust manual vital sign check frequency. The BioButton system empowers healthcare providers to intervene earlier, enhancing safety and making post-discharge care more convenient for patients.
Heartflow One
HeartFlow One: Transforming CCTA for Optimal Coronary Care
HeartFlow One is a sophisticated, evidence-based solution that transforms standard Coronary CT Angiography (CCTA) scans into a dynamic, personalized 3D model of the heart. This tool provides physicians with superior diagnostic performance by offering detailed insights into a patient’s coronary artery disease (CAD), including stenosis severity, lesion-level physiology (FFR-CT), and plaque assessment.
By leveraging this technology, HeartFlow aims to provide clarity and confidence in clinical decision-making. It supports the latest ACC/AHA guidelines recommending CCTA as the frontline test for stable chest pain. The platform promotes efficiency through integration, delivering these detailed insights directly into the PACS and EMR systems for a streamlined workflow. Ultimately, HeartFlow One empowers physicians to make a faster, more optimal diagnosis, avoiding unnecessary tests and improving patient care.
Voalte Platform
Voalte Platform: Unifying Digital Healthcare Communications
The Voalte Platform is a comprehensive digital solution designed to streamline and improve communication within healthcare settings.
It works by unifying care communications for the entire healthcare team, integrating with a hospital’s existing systems to deliver vital patient information directly to clinicians (nurses and doctors) via their smartphones. This accessibility helps to accelerate interventions and ultimately improve patient outcomes.
Voalte helps to elevate care from the bedside to the smartphone, making it easier for caregivers to connect with each other, both inside and outside the hospital, and to involve patients actively in their own care.
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ChronicCareIQ
ChronicCareIQ, a Connected Care platform designed to help medical practices implement and manage Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) programs. The system enhances care quality while simultaneously increasing practice revenue.
Top Benefits of ChronicCareIQ
Improved Visibility (Real-Time Data & Focus):
- The platform provides complete, real-time data on patient status.
- Staff receive automatic notifications when patient trends exceed set clinical thresholds, allowing them to prioritize care for the highest-need patients.
- In-depth monthly trend reports offer both clinical and financial insights into the programs’ success.
Improved Patient Outcomes (Proactive Management):
- The platform keeps the care team continuously informed of patient status in between office visits.
- Access to real-time data allows staff to proactively manage patients’ chronic and complex conditions, leading to better patient outcomes.
Increased Staff Productivity (Automation & Efficiency):
- Proactive patient engagement reduces inbound phone calls and follow-up time.
- The system automatically captures and documents care coordination activities (phone calls, EHR time) required for reimbursement.
- This automation allows practices to support more patients without increasing staff size.
Better Reimbursements (Simplified Billing):
- The platform helps practices get reimbursed for care management work they are already doing.
- It automatically prepares all necessary billing documentation each month, simplifying the process and allowing staff to focus on patients.
- The system helps capture rising CMS reimbursement rates for preventative care services.
MyLab C30 Ultrasound Machine
Esaote’s new MyLab C30 Cardio, launched in 2025, addresses critical gaps in cardiac care by integrating real-time AI guidance like its HeartScan Assistant for optimized image quality.
This system is strategically designed for use across multiple settings, from hospitals to ambulances, driving the industry shift toward AI-guided POCUS adoption (similar to GE HealthCare’s Venue family).
The primary value proposition of the C30 Cardio centers on efficiency and expanded access:
Life-Saving Speed: AI cuts exam time and improves image quality instantly, facilitating earlier intervention for time-sensitive conditions.
Diagnostic Quality, Everywhere: The system empowers non-specialists in rural networks and emergency field settings to capture high-quality cardiac images.
Resource Flexibility: It enables better utilization of staff and resources, providing specialized diagnostics even in facilities lacking dedicated specialists.
Clave IV Connectors
The new FDA 510(k) regulatory clearance for ICU Medical’s Clave portfolio of Needlefree IV Connectors allows for a new labeling claim highlighting peer-reviewed study data. This data suggests that acute care hospitals standardizing on Clave technology and utilizing the Needlefree IV Connectors in high volumes may achieve a 19% lower relative risk of Central Line-Associated Bloodstream Infection (CLABSI), along with associated benefits of lower healthcare costs and reduced mortality, compared to non-Clave hospitals.
The use of the Clave NCT, in and of itself, is an effective risk reduction strategy for CLABSI prevention, reduced mortality, and substantial cost savings.
In addition to the CLABSI reduction statement, ICU Medical’s instructions for use included with these products will also reflect enhanced attributes, including use with blood with no required changeout after infusion or aspiration, and the prevention of microbial ingress for seven days.
LUCAS
The LUCAS (Lund University Cardiac Assist System) is a battery-powered mechanical device that provides automated chest compressions to patients experiencing cardiac arrest, ensuring consistent, high-quality compressions that can improve patient outcomes and reduce rescuer fatigue. Originating from research at Lund University in Sweden, the LUCAS device is used in both hospital and pre-hospital settings and features a plunger device with a suction cup that fits around the patient’s chest to deliver effective compressions at a set depth and rate.
Key Benefits:
Consistent Compressions
Delivers chest compressions at a consistent rate and depth, unlike manual compressions which can be affected by rescuer fatigue.
Reduced Rescuer Fatigue
Eliminates the need for prolonged manual chest compressions, freeing up emergency personnel to perform other critical tasks during resuscitation.
Improved Circulation
Provides an adequate circulation to the brain and other vital organs.
Mobile
The device is small and compact, making it easy to transport and use in ambulances, helicopters, and hospitals.
INSPIRA ART500
The INSPIRA™ ART500: A New Hope for Patients in the ICU
Every year, 20 million patients are placed on mechanical ventilators in the ICU. This often requires them to be put into a coma with a tube down their throat, a process that carries significant risks and medical complications. The INSPIRA™ ART500 is a new technology designed to help these patients stay awake and avoid mechanical ventilation altogether.
How It Works
The INSPIRA™ ART500 delivers oxygen directly into the blood while removing carbon dioxide. This innovative approach aims to raise oxygen saturation levels to 95% or higher in just minutes. By treating patients without mechanical ventilation, the technology could reduce the risk of lung infections and injuries.
The device also continuously monitors blood parameters in real-time. By tracking small volumes of blood, it can rapidly detect life-threatening medical conditions and provide doctors with crucial data to assist in decision-making.
By challenging the traditional foundations of life support, the INSPIRA™ ART500 offers a new path for patient care—one that could potentially reduce a patient’s time in the hospital.
Lifemotion ECMO System
The Lifemotion® ECMO system is an advanced life support technology designed to be both reliable and user-friendly. Its cutting-edge features ensure optimal performance and patient safety.
- Display Panel: A high-resolution screen provides real-time monitoring of key parameters, helping you operate the system accurately and efficiently.
- Console: The compact, user-friendly design seamlessly integrates into any clinical setting.
- Independent Battery Pack: A long-lasting battery ensures uninterrupted operation during transport or emergencies.
- Pumpdrive & Emergency Pumpdrive: The main pump provides optimal flow and pressure, while a built-in emergency pump offers crucial redundancy for added safety in critical situations.
