Presage Technologies Unveils Free Access to FDA-Cleared Contactless Vital Signs Technology; CliniComp Secures FDA Clearance for MIMPS PACS Viewer with Unified Imaging and AI Capabilities; Advita Ortho Strengthens the Scientific Foundation for Predictive Planning in Total Knee Arthroplasty; RunStar® Expands Health Device Portfolio with New Smart Blood Pressure Monitor; Nyra Medical Initiates ENHANCE Early Feasibility Study with First Patient Enrollment; Penumbra Enrolls First Patient in FORWARD Study for Distal Acute Ischemic Stroke

Presage Technologies Earned FDA Clearance for Contactless Vital Signs, Makes Them Available for Free 

On 07 July 2026, Presage Technologies announced that its SmartSpectra Vital Signs Monitor 1.0 SDK received U.S. FDA 510(k) clearance (K254169) for both iOS and Android platforms and made the FDA-cleared contactless pulse rate and breathing rate monitoring capabilities available free of charge. The initiative enabled hospitals, clinics, global health organizations, and educational institutions to access FDA-cleared vital sign monitoring using a standard mobile device camera without any cost.

Mark Oliver, Founder and CEO of Presage Technologies, stated, “Over 90% of Americans have a smartphone, but more than 25 million lack access to regular healthcare, with affordability and accessibility being the primary drivers. We are making this technology free as part of our mission to close that gap.”

The FDA-cleared SmartSpectra technology measured pulse rate and breathing rate without requiring wearable sensors, physical contact, or specialized hardware. In addition to the FDA-cleared mobile solution, the broader SmartSpectra SDK platform was made available across Mac, Linux, Windows, iOS, and Android, allowing developers, healthcare organizations, and businesses to integrate contactless vital sign monitoring into their own applications. The platform also supported additional capabilities, including uncalibrated arterial pressure waveform capture, breathing waveform analysis, heart rate variability assessment, and facial expression analytics. According to the company, SmartSpectra achieved FDA accuracy requirements, recording a root mean square error (RMSE) of 1.32 beats per minute (BPM) for heart rate and 1.75 breaths per minute (BrPM) for breathing rate. These performance results had been peer-reviewed and published.

Presage Technologies stated that the FDA 510(k) clearance followed several years of in-house validation, laboratory testing, and clinical evaluation conducted at Baylor College of Medicine. The clinical study included 111 participants representing diverse skin tones, age groups, and body mass index (BMI) categories, demonstrating the technology’s performance across a broad patient population.

Jim Winkelmann, Chief Technology Officer of Presage Technologies, stated, “This has been years of work by an incredible team, and getting FDA clearance for camera-based vital signs is a moment we are really proud of. We have put a lot of work into making contactless health monitoring and remote health monitoring something that actually works in the real world. This milestone proves that our lean, high-velocity team can deliver clinical-grade accuracy that meets the same stringent standards as established medical device manufacturers. We are excited to keep building toward a future where contactless vital signs monitoring is something anyone, anywhere can access.”

The company noted that FDA 510(k) clearance demonstrated that SmartSpectra met the same regulatory accuracy standards applied to remote patient monitoring devices currently used in clinical practice. Presage Technologies stated that the SDK offered remote patient monitoring companies, AI healthcare developers, and medical device manufacturers access to the validated and peer-reviewed technology across iOS, Android, Mac, Linux, and Windows platforms.

In addition, Presage Technologies launched Coherence by Presage Tech, a remote vital signs monitoring application for both consumers and enterprise users seeking contactless vital sign measurement. The application became available through the Apple App Store and on a limited number of Android devices via the Google Play Store, while developers and device manufacturers were able to integrate the SmartSpectra SDK into their own products to leverage the underlying contactless monitoring technology.

As per DelveInsight’s “Vital Sign Monitoring Devices Market Report,” The global vital sign monitoring devices market size is expected to increase from USD 8,450.49 million in 2024 to USD 14,993.94 million by 2032, growing at a CAGR of 7.48% during the forecast period from 2025 to 2032. The market of vital sign monitoring devices is being primarily driven by the rising prevalence of chronic disorders, increasing health consciousness, the popularity of fitness tracking, increasing technological advancement, and an increase in product development activities among the key market players.

FDA Cleared CliniComp PACS Viewer (MIMPS), Unifying Diagnostic Imaging, Enterprise EHR, and Native AI in a Single Platform

On 07 July 2026, CliniComp announced that it received U.S. FDA 510(k) clearance for its PACS (Picture Archiving and Communication System) Viewer as a Medical Image Management and Processing System (MIMPS). The clearance enabled diagnostic-quality image viewing and advanced image processing directly within the company’s New Era EHR with Native AI Solution Suite, further expanding its unified enterprise platform by integrating diagnostic imaging, clinical workflows, and AI-powered decision support into a single patient record.

Traditionally, clinicians had to switch between separate PACS and electronic health record (EHR) systems to access imaging and patient information. With the FDA-cleared PACS Viewer, CliniComp enabled physicians to view, manipulate, and analyze diagnostic images directly within the patient chart, helping accelerate clinical decision-making while reducing workflow interruptions.

Chris Haudenschild, CEO of CliniComp, stated, “Healthcare organizations have spent decades managing separate clinical, imaging, and administrative systems. With FDA clearance of our PACS Viewer, we’re extending our unified EHR strategy to enterprise imaging, allowing clinicians to access diagnostic-quality imaging, advanced image processing, patient data, and native AI capabilities from a single platform. This creates a more integrated and connected enterprise experience for providers and a stronger foundation for patient care.”

The company stated that, when combined with its Native AI capabilities, the platform could correlate imaging studies with relevant clinical information, including laboratory results, vital signs, medication records, and patient history. This integration was designed to help clinicians identify and prioritize critical cases more efficiently while supporting informed decision-making at the point of care.

The FDA-cleared integrated MIMPS PACS Viewer offered several key capabilities, including diagnostic-quality image viewing with advanced image processing tools directly within the EHR, presentation of imaging studies alongside comprehensive patient clinical data, embedded AI-powered documentation and workflow automation, and intelligent prioritization of high-acuity imaging studies based on real-time clinical context.

Built on CliniComp’s unified enterprise architecture, the FDA-cleared PACS Viewer further advanced the company’s vision of a single, longitudinal patient record by embedding diagnostic imaging directly into routine clinical workflows. According to the company, the integrated platform provided faster access to patient information, streamlined provider workflows, and established a stronger foundation for AI-enabled healthcare delivery.

As per DelveInsight’s “Electronic Health Records Market Report,” The global electronic health records (EHRs) market was valued at USD 34,029.14 million in 2024, growing at a CAGR of 5.86% during the forecast period from 2025 to 2032 to reach USD 53,554.58 million by 2032. The overall market for Electronic Health Records (EHR) is witnessing strong growth due to the rising prevalence of chronic diseases, which necessitates continuous monitoring, data tracking, and long-term care coordination. This growing need has driven demand for integrated healthcare systems that can seamlessly connect patient information across various departments and care settings. In response, governments around the world are implementing supportive initiatives and policies such as funding, mandates, and regulatory frameworks to accelerate EHR adoption and enhance healthcare efficiency. Additionally, key market players are intensifying their product development activities, introducing advanced, user-friendly, and interoperable EHR solutions that incorporate artificial intelligence and data analytics. Together, these factors are creating a favorable environment for the widespread deployment of EHR systems, ultimately boosting the market’s growth during the forecast period from 2025 to 2032.

Advita Ortho Expanded Scientific Evidence Advancing the Future of Predictive Planning for Total Knee Arthroplasty 

On 08 July 2026, Advita Ortho announced new peer-reviewed evidence supporting the advancement of its Newton® knee balancing intelligence platform, reinforcing its role in enabling more predictive, measurement-based decision-making in total knee arthroplasty (TKA). The newly published research highlighted how the technology measured ligament behavior in real time throughout the full range of motion and converted soft tissue dynamics into objective intraoperative data, helping surgeons achieve more consistent and reproducible surgical planning and execution.

Laurent Angibaud, Senior Vice President, Advanced Surgical Technologies at Advita Ortho, stated, “This body of research demonstrates how objective soft tissue data can be processed to enhance the planning of patient-specific targets. As this dataset expands and is reinforced by a growing volume of peer-reviewed research, it becomes increasingly powerful. Backed by our growing intellectual property portfolio, we are enabling more consistent, reproducible planning today, while laying the groundwork for predictive decision-making in the future.”

The findings, published across leading journals including the Journal of Arthroplasty, Journal of Orthopaedic Research, and Arthroplasty Today, demonstrated the value of incorporating real-time dynamic soft tissue measurements into surgical planning. One study showed that integrating soft tissue laxity into planning algorithms improved surgical planning, while additional studies highlighted the potential of machine learning models to support predictive decisions such as tibial insert selection and patient-specific balancing strategies. Researchers also introduced a new classification framework that defined knee phenotypes using dynamic intraoperative measurements, further strengthening the role of objective measurement, machine learning, and standardized frameworks in delivering more personalized and consistent TKA outcomes.

James Huddleston, MD, of Stanford University, commented, “For surgeons, achieving the right balance in a knee replacement remains one of the most complex aspects of the procedure. While real-time, objective data across the range of motion from the Newton solution already provides a clearer understanding of each patient’s knee and supports more reproducible decisions, this body of research helps establish the foundation for translating those insights into self-generated patient-specific planning.”

The company also noted that Newton® knee soft tissue balancing formed part of its Active Intelligence® ecosystem, which integrated personalized planning, surgical guidance, and data-driven insights across total joint procedures. Advita Ortho stated that it would continue expanding its data foundation to support future developments in smart planning, predictive analytics, and surgical decision support.

As per DelveInsight’s “Total Knee Arthroplasty Market Report,” The global total knee replacement market was estimated at USD 9.8 billion in 2024. The market is expected to grow from USD 10.2 billion in 2024 to USD 16.3 billion in 2032, at a CAGR of 5.3% during the forecast period. Growth is driven by the rising prevalence of osteoarthritis, obesity, and technology-driven.

RunStar® Introduced New Smart Blood Pressure Monitor Designed for Easy At-Home Health Tracking 

On 08 July 2026, RunStar® expanded its portfolio of at-home health monitoring devices with the launch of the Smart Blood Pressure Monitor (BP-206), designed to provide users with a simple and convenient way to measure, monitor, and manage their blood pressure from home. The new device strengthened the company’s range of personalized health technologies by combining accurate blood pressure measurement with connected digital health tracking.

Frank Li, Founder of RunStar, stated, “At RunStar, we are dedicated to empowering people to take proactive control of their health by making high-quality health data a normal part of daily life, rather than an intimidating hurdle. This new version of the blood pressure monitor is designed to fit seamlessly into any lifestyle, making advanced health insights, such as cardiovascular health, both simple and accessible.”

The BP-206 was designed to deliver accurate blood pressure measurements using advanced sensors and proprietary VTEC (Vibrational Technology Electronic Control) technology, which had been developed through decades of research. The monitor provided reliable readings in less than 60 seconds and connected to the RunStar mobile application via Bluetooth, enabling automatic synchronization of measurement data. Users could review historical trends, access graphical reports, and share their results when required.

The device featured a 5-inch LED display with large, easy-to-read text, a three-color blood pressure indicator for quick interpretation of results, and voice broadcast functionality to improve accessibility, particularly for elderly users. It also included an adjustable cuff that accommodated arm circumferences ranging from 8.6 to 16.5 inches, ensuring a comfortable fit for a broad range of users.

Additional features included dual-user memory capable of storing up to 99 readings per user, a Guest Mode for temporary measurements, a rechargeable battery that achieved a full charge in approximately 1.5 hours and provided up to five months of use on a single charge, and Smart Cuff Detection technology that alerted users if the cuff was not properly positioned to ensure accurate readings.

The company also announced that the RunStar Smart Blood Pressure Monitor (BP-206) became available for purchase at a retail price of USD 69.99. To mark the product launch, RunStar introduced a limited-time promotional discount and confirmed that the device was eligible for HSA/FSA reimbursement, further supporting its objective of making advanced health monitoring more accessible for everyday wellness management.

According to DelveInsight’s “Blood Pressure Monitoring Devices Market Report,” the global blood pressure monitoring devices market is expected to increase from USD 2,842.32 million in 2024 to USD 6,086.50 million by 2032, growing at a CAGR of 10.01% during the forecast period from 2025 to 2032.

The market of blood pressure monitoring devices is being primarily driven by the rising prevalence of hypertension and cardiovascular diseases, increasing shift towards home healthcare & remote patient monitoring, increasing technological advancements in devices, and an increase in product development activities among the key market players.

Nyra Medical Announced First Patient Enrollment in ENHANCE Early Feasibility Study, Advancing Next Generation Mitral Valve Repair Platform 

On 07 July 2026, Nyra Medical, Inc. announced the enrollment of the first patient in the ENHANCE Early Feasibility Study (EFS), which evaluated the investigational CARLEN™ System for the treatment of functional mitral regurgitation (FMR). The enrollment marked a key milestone in the company’s clinical development program and followed encouraging First-in-Human clinical results, where the CARLEN System restored native mitral valve coaptation while preserving physiological valve function in treated patients. The ENHANCE EFS was designed to assess the safety, feasibility, and procedural performance of the investigational device in patients with symptomatic FMR.

The multicenter study involved leading structural heart centers across the United States and Brazil and represented the next phase of Nyra Medical’s global clinical evidence generation strategy.

Jennifer Mischke, Senior Vice President of Clinical, Regulatory & Quality at Nyra Medical, stated, “The initiation of our ENHANCE Early Feasibility Study reflects years of engineering innovation, disciplined clinical preparation, and close collaboration with world-renowned physicians. This milestone validates both the strength of our clinical development program and our commitment to bringing physicians an innovative treatment option designed to expand access to transcatheter mitral valve repair. We are excited to begin generating the clinical evidence that will support future regulatory and commercial milestones.”

The investigational CARLEN™ System was developed as an alternative to conventional transcatheter edge-to-edge repair approaches. It was designed to augment the native mitral leaflet without the use of sutures, tethers, or permanent modification of the valve anatomy. The device aimed to restore leaflet coaptation while maintaining physiological leaflet motion and preserving future treatment options for patients.

Dr. Gagan Singh, Principal Investigator and Director of the Structural Heart Program at UC Davis Health, stated, “Functional mitral regurgitation remains one of the most challenging conditions we treat because many patients have complex anatomy or underlying ventricular disease that can limit existing transcatheter repair options. The CARLEN System introduces a differentiated repair strategy that is intended to alleviate the limitations of current transcatheter approaches, addressing an important unmet clinical need and expanding the options available to physicians treating these patients. We are excited to be the first U.S. center participating in the ENHANCE Early Feasibility Study and look forward to supporting the clinical evidence needed to evaluate this novel therapy.”

The ENHANCE Early Feasibility Study was designed as a prospective, multicenter, single-arm clinical trial to evaluate the safety, performance, and clinical outcomes of the CARLEN System in patients with symptomatic moderate-to-severe or severe functional mitral regurgitation. The study planned to follow enrolled patients for up to five years and was being conducted at leading structural heart centers in the United States and other international locations.

The company noted that the ENHANCE Early Feasibility Study represented the culmination of several years of technology development and collaboration with internationally recognized structural heart specialists. Nyra Medical also acknowledged the contributions of Dr. Edwin Ho, Dr. Azeem Latib, and Dr. Susheel Kodali, whose clinical expertise, strategic guidance, and support during the initial procedures helped shape the development of the CARLEN™ System and advance the clinical program to this milestone.

According to DelveInsight’s ”Transcatheter Mitral Valve Repair Devices Market Report,” The transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.

First Patient Enrolled in Penumbra’s FORWARD Study Evaluating Mechanical Thrombectomy and Computer-Assisted Vacuum Thrombectomy for Distal Acute Ischemic Stroke 

On 07 July 2026, Penumbra, Inc. announced the initiation of the FORWARD study, an international, prospective, real-world, multicenter clinical study designed to evaluate the safety and effectiveness of mechanical thrombectomy in the treatment of acute ischemic stroke caused by distal occlusions. The study assessed mechanical thrombectomy technologies, including computer-assisted vacuum thrombectomy (CAVT™) and modulated aspiration, with the first patient being treated by Dr. Keith Woodward, a neurointerventional radiologist at Vista Radiology in Knoxville, Tennessee.

The FORWARD study was designed to evaluate Penumbra’s RED reperfusion catheter portfolio, including THUNDERBOLT, the first CAVT platform to deliver modulated aspiration for the treatment of acute ischemic stroke involving M2 occlusions.

Nitin Goyal, M.D., co-principal investigator of FORWARD and endovascular neurologist at Semmes-Murphey Neurologic and Spine Institute in Memphis, Tennessee, stated, “Distal occlusions are among the more difficult strokes to treat as medical interventions for patients in this population have historically provided limited benefit. FORWARD is a prospective study designed to evaluate whether that paradigm can change. Mechanical thrombectomy has an established safety profile and a strong track record in treating large vessel occlusions. With the latest advancements designed for navigating deeper into the brain, the FORWARD study aims to determine whether these same benefits can extend to distal occlusions and help pave the way for an important treatment option for a patient population that has limited choices.”

The FORWARD (Functional Outcomes in Real-World Treatment and Revascularization of Non-dominant and Distal M2 Occlusions) study planned to enroll up to 250 participants across approximately 40 clinical sites. The trial evaluated the company’s RED reperfusion catheter portfolio, including the THUNDERBOLT CAVT platform, in patients with M2 occlusions. The study included patients who received medical management alone as well as those treated with a combination of mechanical thrombectomy and medical management.

Alex Spiotta, M.D., co-principal investigator of FORWARD and Chief of the Department of Neurosurgery and Director of Neuroendovascular Surgery at the Medical University of South Carolina, stated, “Enrolling the first patient in FORWARD is an important milestone in understanding the true impact of mechanical thrombectomy on distal occlusions. We have already seen how mechanical thrombectomy can positively benefit patients with acute ischemic stroke by rapidly restoring blood flow to the brain and improve patient outcomes. The results of this study will help inform physicians on treatment selection for stroke patients with M2 occlusions, potentially supporting wider adoption of mechanical thrombectomy for this challenging condition.”

The company noted that stroke remained the third leading cause of death and disability worldwide, with approximately 11.9 million new cases reported in 2021 and nearly 94 million individuals living with long-term stroke-related disabilities. It also highlighted that distal vessel occlusions accounted for approximately 25–40% of acute ischemic strokes, while M2 occlusions represented an estimated 3–7% of cases, corresponding to approximately 21,000–66,000 M2 stroke cases annually.

James F. Benenati, M.D., FSIR, Chief Medical Officer at Penumbra, stated, “FORWARD will deepen the medical community’s understanding of how mechanical thrombectomy, specifically our latest catheter and CAVT technology, can more effectively address the complexity of M2 stroke. Penumbra’s commitment to clinical research offers more insight into how our innovations translate to real-world patient outcomes, reinforcing our mission to develop the most meaningful treatment options for challenging medical conditions.”

The company also noted that THUNDERBOLT had recently received both CE Mark certification and U.S. FDA clearance. The device introduced modulated aspiration technology into Penumbra’s neurothrombectomy portfolio and was designed to detect, fatigue, and completely ingest clots at the site of vascular occlusion using advanced computer-assisted vacuum thrombectomy (CAVT) technology.

According to DelveInsight’s “Thrombectomy Devices Market Report,” The thrombectomy devices market was valued at USD 1,656.88 million in 2024, growing at a CAGR of 6.83% during the forecast period from 2025 to 2032 to reach USD 2,806.85 million by 2032. The growing demand for thrombectomy devices is driven by several key factors supporting strong market growth. The rising global prevalence of neurological and cardiovascular conditions such as acute ischemic stroke, pulmonary embolism, and deep vein thrombosis, among others necessitate timely, effective interventions. Additionally, there is a clear shift toward minimally invasive treatment options, preferred by both patients and healthcare providers. Further fueling growth in the market is the continuous innovation and product launches by leading players, which are investing in advanced technologies and launching next-generation products that enhance procedural efficiency and outcomes. Collectively, these trends are creating a favorable environment for sustained market expansion from 2025 to 2032.