Utepreva Announces FDA 510(k) Clearance for Endometrial Sampler Aimed at Early Cancer Detection; Sonorous Neurovascular Announces FDA 510(k) Clearance of BosCATH Neurovascular Catheter; OrganaBio and RxMP Therapeutics Partner to Support Manufacturing of RMP-402 Hemostatic Therapy; RhythMedix Introduces the New RhythmStar® SL Advanced Cardiac Monitor; Nicklaus Children’s Hospital Achieves First Traveling Bedside PDA Closure in Fort Lauderdale NICU; RIVANNA Advances Multi-center Clinical Study of Accuro XV Musculoskeletal Imaging System

Utepreva Introduced FDA 510(k)-Cleared Endometrial Sampler Designed to Support Early Detection of Endometrial Cancer

On 22 April 2026, Utepreva LLC announced the launch of the Utepreva Endometrial Sampler, a patented, FDA 510(k)-cleared, single-use endometrial sampling device designed to enhance tissue capture and support early diagnostic evaluation of endometrial cancer. The device featured a proprietary design that combined three complementary mechanisms to enable the comprehensive collection of tissue and fluid in a single sampling pass.

Uterine cancer remained the most common gynecologic malignancy in the United States, with rising incidence and mortality rates, while endometrial carcinoma accounted for the majority of cases. An estimated 68,270 new cases were projected for the year, according to the American Cancer Society. Clinical outcomes continued to depend heavily on timing, with survival rates reaching up to 95% when diagnosed at an early stage but dropping below 20% in advanced disease.

The Utepreva Endometrial Sampler was engineered to support early diagnostic evaluation by modernizing office-based endometrial tissue and fluid sampling. It addressed limitations of conventional single-mechanism devices that often compromised tissue yield and delayed definitive diagnosis, thereby aiming to improve the reliability and efficiency of early-stage detection workflows.

“Our mission is to save lives by expanding access to minimally invasive uterine evaluation and aiding clinicians in the detection of pre-cancer, when treatment is less invasive, and survival outcomes are significantly improved,” said Dr. Jeanetta Stega, CEO of Utepreva LLC.

As per DelveInsight’s “Gynecological Devices Market Report,” the global gynecological devices market is estimated to grow at a CAGR of 8.37% during the forecast period from 2025 to 2032. The demand for gynecological devices is primarily being boosted by the increasing figures of gynecological disorders such as cervical dysplasia, pelvic floor prolapse, adnexal tumors, endometriosis, ovarian cysts, uterine fibroids, and others. Further, the rising adoption of advanced and innovative technologies, increasing demand for minimally invasive therapy, rising demand for birth control devices and surgeries, rising awareness about family planning and birth control, and increasing product launches and approvals, among others, are thereby contributing to the overall growth of the gynecological devices market during the forecast period from 2025 to 2032.

Sonorous Neurovascular Received FDA 510(k) Clearance for BosCATH™ Neurovascular Catheter 

On 22 April 2026, Sonorous Neurovascular, a medical device company focused on solutions for cerebral venous diseases and neurovascular interventions, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BosCATH™, a next-generation neurovascular catheter designed to improve access, delivery, and procedural efficiency in complex cerebral venous and arterial anatomies.

This regulatory milestone followed the company’s earlier receipt of FDA Breakthrough Device Designation for its BosSTENT™, a braided self-expanding cerebral venous stent developed to treat symptomatic cerebral venous sinus stenosis associated with pulsatile tinnitus.

BosCATH was engineered to provide enhanced trackability, support, and navigability during challenging neurovascular procedures. The device complemented the company’s portfolio and was specifically intended to facilitate the delivery of advanced therapies such as BosSTENT™ in tortuous venous anatomy. The clearance enabled Sonorous Neurovascular to commercialize BosCATH in the United States, thereby expanding treatment options for interventional neuroradiologists and neurosurgeons.

The company also initiated the international B-SILENT study (NCT07070089) across France and Canada to evaluate the investigational use of BosSTENT™ for treating pulsatile tinnitus caused by cerebral venous sinus stenosis. The study was designed to generate safety and performance data to support a future CE Mark submission.

Sonorous Neurovascular continued to advance its clinical programs across both U.S. and international regulatory pathways, maintaining its focus on improving outcomes for patients suffering from pulsatile tinnitus and other venous outflow disorders through minimally invasive therapies.

“This 510(k) clearance for BosCATH, combined with our recent Breakthrough Device Designation for BosSTENT, represents important progress in our mission to deliver purpose-built devices that address significant unmet needs in neurovascular care,” said Joel Harris, CEO of Sonorous Neurovascular. “We extend our sincere thanks to the entire Sonorous R&D and Regulatory teams for their outstanding dedication and expertise. In particular, we recognize Jake Le, Vice President of R&D, for his exceptional leadership in driving product development from concept to successful 510(k) clearance.”

As per DelveInsight’s “Neurovascular Catheter Devices Market Report,” the global neurovascular catheters market size accounted for USD 6.35 billion in 2025 and is predicted to increase from USD 6.78 billion in 2026 to approximately USD 13.0 billion by 2034, expanding at a CAGR of 7.66% from 2026 to 2035. The market is driven by the rising incidence and prevalence of neurovascular diseases like strokes and brain aneurysms. The neurovascular catheter is a medical device that is useful in the treatment of patients with neurological conditions. It is a tube-shaped device that is used during brain surgeries on patients. Catheters are used in medical devices to be inserted into the body for the treatment of a particular disease, especially during surgeries. These catheters play an important role in various medical procedures, such as monitoring intracranial pressure, administering medications, and injecting contrast agents. The most common application of neurovascular catheters is to manage the condition of hydrocephalus, which helps in regulating the blood flow of cerebrospinal fluid. They are also employed during the treatment of head injuries or during neurosurgery.

OrganaBio and RxMP Therapeutics Announce Manufacturing Partnership to Advance RMP-402 Hemostatic Drug Product

On 22 April 2026, OrganaBio, LLC, a vertically integrated blood and cell products and services company, and RxMP Therapeutics, Inc., a late pre-clinical stage therapeutics company, announced a manufacturing partnership under which OrganaBio served as the contract manufacturing partner for the cGMP production of RxMP’s lead product candidate, RMP-402.

Under the agreement, OrganaBio supported technology transfer, qualification, and cGMP production of RMP-402 by leveraging its integrated manufacturing infrastructure and quality management systems to help advance the drug through key development milestones. The collaboration combined OrganaBio’s expertise in cGMP manufacturing, quality assurance, and analytical development with RxMP’s proprietary hemostatic platform technology.

RMP-402 was a first-in-class hemostatic therapeutic composed of manufactured allogeneic red cell membrane particles (RMPs), designed as analogs of naturally occurring particles in human blood. These particles were developed to rapidly control bleeding when administered intravenously without increasing the risk of unintended clot formation. The therapy was being developed for both civilian and military applications, targeting a global trauma and surgical bleeding market estimated at $12 billion annually, where uncontrolled bleeding remained a major cause of morbidity and preventable deaths.

In 2025, RxMP reached consensus with the U.S. Food and Drug Administration (FDA) regarding its proposed GMP manufacturing process for RMP-402 and entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Defense’s Institute of Surgical Research to further validate the therapy’s potential in treating combat-related injuries.

“OrganaBio was built to be the kind of partner that therapeutics companies need: responsive, rigorous, and deeply invested in our clients’ success,” said Justin Irizarry, Chief Executive Officer of OrganaBio. “We are honored that RxMP has entrusted us with the manufacturing of RMP-402. This is a product that has the potential to fundamentally change how clinicians manage life-threatening bleeding events, and we take that responsibility seriously. Our team is energized by the opportunity to apply our cGMP manufacturing capabilities and quality-first approach to help bring this therapy closer to the patients who need it most.”

As per DelveInsight’s “Cell and Gene Therapy Manufacturing Market Report,” the cell and gene therapy manufacturing market was valued at USD 4,749.18 million in 2024, growing at a CAGR of 9.50% during the forecast period from 2025 to 2032 to reach USD 9,804.90 million by 2032. The rising prevalence of genetic disorders and chronic diseases such as cancer and rare inherited conditions is driving the demand for advanced therapies, thereby increasing the need for robust manufacturing capabilities. Concurrently, the rapid expansion of the cell and gene therapy pipeline, with numerous therapies advancing through clinical trials, is accelerating the demand for scalable and efficient production solutions. Additionally, strategic initiatives by key market players, including partnerships, investments in cutting-edge manufacturing facilities, and advancements in automation technologies, are significantly enhancing production capacity and operational efficiency. Collectively, these factors are expected to substantially propel the growth of the cell and gene therapy manufacturing.

RhythMedix Launched Next-Generation RhythmStar® SL Cardiac Monitor 

On 22 April 2026, RhythMedix, LLC, a U.S.-based cardiac monitoring company, announced the launch of its next-generation RhythmStar® SL cardiac monitoring wearable. The third-generation device was designed to enhance the patient experience by improving comfort, wearability, and adherence. These improvements were achieved through features such as a compact lead configuration, a waterproof IPX-6 rating, and extended battery life.

The updated RhythmStar® SL cardiac monitor was developed to simplify remote monitoring while enhancing usability for patients. It continued to differentiate itself through built-in cellular connectivity, which enabled ECG data to be automatically transmitted to the cloud for timely review across various monitoring modes, eliminating the need for device return by mail for data processing.

When integrated with the company’s proprietary Augmented Arrhythmia Intelligence™ (AAI), RhythmStar SL provided accurate arrhythmia detection by combining advanced algorithms with a multi-layered data review process.

“RhythmStar represents our commitment to delivering a better way to monitor, one that prioritizes both patient comfort and clinical performance,” said Brian Pike, CEO of RhythMedix. “By combining a more wearable design with seamless data transmission and expert review, we’re helping clinicians access the insights they need, when they need them.”

According to DelveInsight’s “Cardiac Monitoring Devices Market Report”, the global cardiac monitoring devices market is expected to increase from ~USD 21,360.61 million in 2024 to ~USD 31,602.55 million by 2032, growing at a CAGR of 5.11% during the forecast period from 2025 to 2032. The overall cardiac monitoring devices market is being strongly boosted by the rising prevalence of cardiovascular diseases and related risk factors, which heightens the need for early detection and continuous monitoring. This demand is further amplified by the growing adoption of remote patient monitoring, allowing real-time heart health management beyond clinical settings. At the same time, technological advancements in device design, including AI integration, miniaturization, and wearables, are making solutions more accurate and patient-friendly. Additionally, increased product development activities by key players are expanding device options and accessibility, collectively driving robust market growth.

First Traveling Bedside PDA Closure Performed at Nicklaus Children’s Hospital, Fort Lauderdale NICU 

On 22 April 2026, the team at Nicklaus Children’s Hospital’s Heart Institute successfully performed the first traveling bedside transcatheter patent ductus arteriosus (PDA) closure on a 22-week-old premature infant weighing 800 grams at Nicklaus Children’s Hospital, Fort Lauderdale, located on the campus of Broward Health Medical Center. The procedure was conducted within the infant’s isolette, allowing interventional cardiologists to close the PDA without transporting the fragile newborn, thereby minimizing associated risks.

The bedside approach improved patient stability and eliminated the stress and risks linked to moving critically ill infants from the Neonatal Intensive Care Unit (NICU) to a catheterization lab. It also enabled earlier intervention, supporting better lung recovery. The minimally invasive procedure involved inserting a small catheter through a vein to place a closure device without requiring a chest incision.

Patent ductus arteriosus, a condition in which a blood vessel fails to close after birth, can lead to excessive blood flow to the lungs, causing breathing difficulties, feeding issues, and impaired growth. The catheter-based technique allowed physicians to close the vessel internally, reducing complications.

The procedure was led by Dr. Shyam Sathanandam, chief of cardiovascular medicine and co-director of the Heart Institute, who has been a pioneer in advancing bedside transcatheter PDA closure techniques globally. In 2018, he launched the International PDA Symposium to promote advancements in managing PDA in preterm infants.

This milestone procedure was performed as part of a strategic collaboration between Nicklaus Children’s Health System and Broward Health, under which pediatric services at Fort Lauderdale and Coral Springs campuses came under Nicklaus Children’s operations. The partnership aimed to expand access to specialized pediatric care while reducing the need for families to travel outside Broward County for advanced treatments.

According to DelveInsight’s ”Interventional Cardiology Devices Market Report,” the global interventional cardiology devices market is expected to increase from USD 20,192.60 million in 2024 to USD 34,866.30 million by 2032, growing at a CAGR of 7.09% during the forecast period from 2025 to 2032. The global interventional cardiology devices market is driven by the growing prevalence of cardiovascular diseases (CVDs) and their associated risk factors, increasing preference for minimally invasive procedures, increasing technological advancement in product design, and an increase in strategic activities among the key market players.

RIVANNA Expanded a Multi-site Clinical Study for the Accuro XV Musculoskeletal Imaging System

On 21 April 2026, RIVANNA®, a developer of AI-enabled clinical decision-support solutions, announced that it had expanded its clinical studies evaluating Accuro® XV, its musculoskeletal imaging system, from two to eight sites across the United States. This expansion followed the execution of a funding option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

The study supported the development of the first automated fracture detection algorithm derived from volumetric ultrasound imaging. RIVANNA’s computer-aided detection (CADe/x) technology was trained on extensive 3D imaging datasets of upper and lower extremity injuries collected from multiple clinical sites, representing a novel advancement in musculoskeletal imaging.

The study also completed validation and training of BoneEnhance®, an image segmentation module designed to improve bone visualization and serve as a step toward the company’s comprehensive diagnostic platform. In addition to dataset development for AI training, the expanded study generated early clinical insights. Preliminary analysis indicated that among patients who did not receive pain medication, imaging with Accuro XV was associated with a smaller increase in pain compared to X-ray (mean change: -0.09 vs. +0.36; p<0.001).

These findings, although not yet published, suggested potential patient comfort advantages alongside the system’s diagnostic capabilities.

“Now that all eight clinical sites are actively enrolling patients, development of AI for fracture detection is anticipated to compress the 510(k)-submission timeline,” said Delphine Le Roux, PhD, PMP, Senior Director, Market Access and Strategic Partnerships at RIVANNA. “Expanding our clinical program from two to eight sites in four months, with a total of 10 systems deployed, is a testament to our strong partnerships, as well as our team’s agility and capabilities. Our ability to rapidly activate clinical sites reflects the trust and engagement we’ve built with leading academic medical centers over the years, partnerships that are essential to advancing this technology.”

According to DelveInsight’s “Portable Ultrasound Devices Market Report,”  the global portable ultrasound devices market was valued at USD 1.84 billion in 2023, growing at a CAGR of 7.33% during the forecast period from 2024 to 2030 to reach USD 2.81 billion by 2030. The demand for portable ultrasound devices is primarily being boosted owing to key factors such as the growing prevalence of chronic diseases such as cancers, and cardiovascular disorders, among others, its wide range of applications for diagnostic purposes, along with the rising number of technological advancements in product development are expected to create a positive impact on the portable ultrasound devices market growth during the forecast period from 2024 to 2030.