“The Essentia bed by Agiliti is designed for greater flexibility and versatility in patient care, backed by over three decades of design innovation and clinical service expertise,” said Tom Leonard, CEO of Agiliti. “Its introduction builds on our long-standing legacy of med-tech product and service solutions that ensure caregivers are equipped to meet the needs of every patient they serve.”
Essentia’s unique design incorporates two groundbreaking safety innovations:
SlideRail: This feature provides up to 39 inches of unobstructed egress space and adjusts to three positions for enhanced support and security as patients enter or exit the bed. Adjustable handholds accommodate different patient sizes and mobility levels while also reducing strain and injury risks for caregivers.
SafeGlance Icons: Integrated, illuminated on-bed icons offer caregivers a quick visual check of critical safety settings, including the bed exit alarm, protocol timer, bed height, and brake status.
Additional Key Features
11.5” Deck Height: One of the lowest available in multi-acuity bed frames, lowering to just 11.5 inches from the floor. Studies indicate that a lower bed height significantly reduces the risk of serious fall-related injuries. Combined with SlideRail™, this feature enhances fall prevention across a broad patient population.
RevTrend 20™ with Weightbearing Footboard: Essentia’s 20-degree reverse Trendelenburg position supports early mobility therapy. Its reinforced footboard enables patients to begin weightbearing exercises sooner.
PowerBrake™ with AutoLock™: Caregivers can easily activate braking, steering, or neutral settings from three locations on the bed. AutoLock engages the brakes automatically after 60 seconds when plugged in, enhancing patient safety.
MotionStop 360™: This system detects obstructions around the base of the bed, automatically stopping bed movement to prevent injuries and equipment damage.
Powered Foot Extension: A customizable bed deck length, adjustable from 80 to 88 inches at the push of a button, offers added versatility for caregivers and patients.
Support Surface Compatibility: Essentia’s flat deck design accommodates a wide range of support surfaces, including more than a dozen Agiliti-manufactured foam and air options. Higher siderails ensure deeper air surfaces meet safety requirements for high-acuity patients.
“We are excited to introduce Essentia, a hospital bed designed to enhance caregiver safety while adapting to the diverse needs of patients,” said Tim McCarty, General Manager of Beds and Therapeutic Support Surfaces at Agiliti. “With its advanced features, Essentia will help accelerate patient mobility and support faster hospital discharges.”
As per DelveInsight’s “ Hospital Beds Market Report,” the escalating demand for hospital beds can be attributed to multiple significant factors. Firstly, there’s a notable uptick in surgical procedures and accidents, necessitating the availability of adequate beds for patient care and recovery. Secondly, the aging population worldwide requires more healthcare services, including long-term care and rehabilitation, which further fuels market expansion. Concurrently, the growing prevalence of acute and chronic diseases is placing a greater strain on healthcare facilities, driving the need for additional bed capacity to accommodate patients requiring treatment and monitoring. Furthermore, the healthcare sector is witnessing a surge in product launches, introducing innovative bed designs and features that enhance patient comfort and facilitate better care delivery. The rise in healthcare infrastructure investments, particularly in emerging economies, also plays a crucial role, as it leads to the establishment of new hospitals and the expansion of existing facilities. This convergence of factors underscores the increasing demand for hospital beds during the forecast period of 2024 to 2030.
KUBTEC Launched PICASSO® Plus: The Next Generation of Specimen Imaging for the Pathology Lab
On February 11, 2025, KUBTEC®, a global leader in pathology specimen imaging technology, introduced The PICASSO® Plus Specimen Radiography System, its latest innovation designed to enhance efficiency in pathology labs.
The PICASSO® Plus System is the only specimen imaging solution for pathology labs that leverages Amorphous Selenium Direct Capture Technology—the same advanced technology found in top-tier mammography systems. It also features a suite of proprietary workflow management tools, including the highly acclaimed Image Blender™, which utilizes Dual Specimen Imaging to merge X-ray and optical images. This capability enables Pathologists’ Assistants to quickly identify surgical clips, margins, and microcalcifications with precision.
A special launch event at KUBTEC headquarters in Stratford CT was attended by Paul S. Lavoie, Chief Manufacturing Officer of the State of Connecticut. At the ribbon-cutting ceremony Mr. Lavoie shared a few words:
“This is absolutely amazing, groundbreaking work, and it’s been done here in Connecticut. We have the most advanced and innovative workforce in the nation. Congratulations KUBTEC on your latest product development, which is incredibly significant [for healthcare].”
Vikram Butani, CEO of KUBTEC®, shared the vision that led to the launch of the PICASSO® Plus System “Amorphous Selenium Direct Capture Technology is the gold standard for diagnostic mammography. With the latest PICASSO® Plus System, we complete the chain, bringing Amorphous Selenium from Mammography to the OR and now to Pathology. The high-quality images used to diagnose breast cancer will now also be used to help analyze breast tissue in the pathology lab.”
The PICASSO® Plus System introduces several advanced features, including voice command technology, enabling hands-free navigation through innovative speech recognition. Additionally, the system is equipped with the Pablo® tablet, providing seamless access to images and annotation tools from anywhere in the pathology lab. This enhances workflow efficiency, ensuring a smooth transition to the grossing station and beyond. The Pablo® tablet also supports voice and gesture commands, offering a fully touch-free experience.
According to DelveInsight’s “Digital Radiography Systems Market Report”, the global digital radiography or X-ray systems is expected to grow at a CAGR of 5.53% during the forecast period from 2024 to 2030. The digital radiography systems market is witnessing positive growth owing to various factors such as rising cases of cancer, chronic disorders such as cardiovascular disorders, orthopedic, & other disorders, and the escalating burden of the geriatric population. Additionally, technological advancements pertaining to digital radiography systems such as high-quality image acquisition in short duration by digital detectors and reduced radiation exposure, among others will also aid in the growth of the digital radiography systems market. Therefore, the market for digital radiography systems is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
Neuvotion Received FDA Clearance for NeuStim™ Providing Non-Invasive, High-Resolution Stimulation for the Hand After Stroke or Spinal Cord Injury
On February 12, 2025, Neuvotion, Inc. is an early-stage medical device company specializing in AI-driven neuromodulation technologies for neurorehabilitation, brain-computer interface (BCI), and physical therapy applications. The company received FDA 510(k) clearance for its first product, NeuStim™—a non-invasive, surgery-free wearable that delivers dynamic, high-precision electrical muscle stimulation.
Designed to aid hand movement recovery after stroke or spinal cord injury, NeuStim™ features an intuitive touch-screen interface that enables clinicians to quickly scan and identify optimal stimulation targets. Stimulation profiles can be easily configured and saved for each user through a graphical interface on a lightweight mobile device. Neuvotion plans to launch NeuStim™ in the coming year.
“At Neuvotion we are developing highly innovative technologies built on two decades of scientific research yielding effective and easy-to-use products,” said Chad Bouton, Neuvotion’s founder and CEO. “We are extremely excited about NeuStim™, our first product, which we believe will be a game-changer in the neuromodulation, brain-computer interface, and neurorehabilitation markets.”
“We have been very impressed with Professor Bouton’s groundbreaking foundational research and Neuvotion’s highly innovative approach,” said Michael Spigel, PT, MHA, President & CEO of Good Shepherd Rehabilitation. “We look forward to continuing as a clinical research partner with Neuvotion. We feel that NeuStim™ is truly revolutionary and will help produce improved outcomes in stroke and spinal cord injury rehabilitation.”
As per DelveInsight’s “Neuromodulation Devices Market Report,” the neuromodulation devices market was valued at USD 5.71 billion in 2023, growing at a CAGR of 8.95% during the forecast period from 2024 to 2030 to reach USD 9.56 billion by 2030. The demand for neuromodulation devices is primarily driven by the growing prevalence of neurological disorders and the increasing number of patients suffering from chronic pain. Additionally, increasing research and development activities and collaborations among key players significantly contribute to market growth. The rising aging population further compounds this demand, as older adults are more susceptible to neurological conditions and chronic pain. These factors collectively position the neuromodulation devices market for positive growth during the forecast period from 2024 to 2030.
Ibex Medical Analytics Received First FDA 510(k) Clearance
On February 10, 2025, Ibex Medical Analytics (Ibex), a leading provider of AI-driven cancer diagnostics, announced that its in vitro diagnostic medical device, Ibex Prostate Detect, received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This AI-powered tool generates heatmaps to identify small and rare missed prostatic cancers, serving as a safety net to support pathologists in delivering accurate diagnoses to patients.
“Prostate cancer is one of the most prevalent cancers worldwide, with an estimated one in eight men diagnosed in their lifetime. With the global incidence expected to double by 2040, accurate and timely diagnoses are more critical than ever. Advancements in AI-powered pathology can support pathologists in delivering precise and efficient diagnoses, ultimately improving patient outcomes,” shared Ibex scientific advisor Mahul B. Amin, MD, Vice President and Medical Director of Labcorp’s Hospital Systems Operating Division and Clinical Professor of Pathology and Laboratory Medicine at the University of Tennessee Health Science Center.
Ibex Prostate Detect is a software-based device designed to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin-embedded tissue. Its primary function is to detect tumors that may have been overlooked by the pathologist. When suspicious prostate cancer tissue is identified, the system generates case- and slide-level alerts and provides a heatmap to guide the pathologist to areas likely containing cancer.
In rigorous precision and clinical validation studies conducted across multiple laboratories in the U.S. and Europe as part of the FDA clearance process, the system achieved a 99.6% positive predictive value (PPV) for cancer heatmap accuracy. Additionally, it identified a 13% rate of missed cancers in a cohort of consecutive patients initially diagnosed as benign. Expert pathologists later confirmed these missed cases (false negatives), highlighting the product’s clinical utility and advantages over the current standard of care.
“The FDA clearance marks a significant milestone in Ibex’s journey and exemplifies our dedication to developing clinically validated solutions that help improve patient health outcomes,” said Joseph Mossel, Chief Executive Officer at Ibex Medical Analytics. “This clearance affirms our commitment to the safety and efficacy of our AI solutions and strengthens our ability to provide cutting-edge innovation to pathologists, which ultimately benefit patients. We hope this accomplishment will bolster industry-wide confidence that AI-powered digital pathology is ready for widespread clinical adoption.”
With the global rise in cancer incidence, the growing demand for diagnostics and increasing workloads are further strained by a worldwide shortage of pathologists. Their roles are becoming increasingly complex with advancements in precision medicine. Ibex’s platform addresses these challenges by equipping pathologists with AI-powered tools that enhance diagnostic accuracy and optimize workflows. This ensures that every patient receives a precise and timely diagnosis, which is crucial for guiding treatment decisions and improving cancer survival rates.
The Ibex platform, widely deployed in routine clinical settings worldwide, offers prostate, breast, and gastric solutions that equip pathologists with powerful AI-driven tools to aid in the detection of cancer and other clinically significant findings, while enhancing case review workflows. The platform features CE-IVD certified solutions (under the IVDR framework) and is registered with the UK MHRA, the TGA in Australia, and ANVISA in Brazil. Ibex Prostate Detect has received FDA clearance, while other solutions are designated as Research Use Only (RUO) in the United States. Ibex holds various quality and security certifications, including HITRUST, Cyber Essentials Plus, ISO 27001, and ISO 13485, among others.
As per DelveInsight’s “In-Vitro Diagnostic Market Report,” the global in vitro diagnostics market was valued at USD 71.01 billion in 2023, growing at a CAGR of 4.71% during the forecast period from 2024 to 2030, to reach USD 93.60 billion by 2030. The in vitro diagnostics market is estimated to register positive revenue growth owing to factors such as the rising prevalence of various infectious diseases such as COVID-19, the growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities for in vitro diagnostics among others.
BlueWind Medical Announced Peer-Reviewed Data Showing Excellent Durability of Results for Revi® System at Two Years
On February 07, 2025, BlueWind Medical, Ltd., a leader in implantable Tibial NeuroModulation (iTNM) and the developer of the Revi® System, a patient-focused solution for urgency urinary incontinence (UUI), announced the publication of the two-year results from the pivotal OASIS study in the March 2025 issue of the Journal of Urology.
The OASIS study is a prospective, multicenter, single-arm, open-label clinical trial involving 151 adult women (mean age 58.8 years) with urgency urinary incontinence (UUI), specifically overactive bladder-wet syndrome (OAB-wet). The study assessed the efficacy and safety of the Revi system in treating UUI symptoms in patients with OAB-wet. Primary efficacy and safety endpoints were evaluated at six and twelve months, with 97 participants consenting to and completing the 24-month follow-up assessment.
Key findings at two years highlight Revi’s long-lasting efficacy, excellent safety profile, and high patient satisfaction, reinforcing its effectiveness in treating UUI. Notably, a sustained therapeutic response was seen with a more flexible, provider- and patient-driven schedule in the second year (≥ two 30-minute sessions per week) compared to the first year (30-minute daily sessions). On average, patients completed at least one treatment session on eight out of ten days, with the schedule tailored to their individual symptom needs.
The two-year analysis of the OASIS study demonstrated that Revi delivered sustained therapeutic benefits, including:
- A durable reduction in UUI episodes, with 79% of participants experiencing at least a 50% reduction and 56% achieving at least a 75% reduction.
- High satisfaction rates, with 97% of participants reporting satisfaction and 97% feeling “better” to “very much better.”
- Freedom from leaks, with 28% of patients remaining dry on a three-day voiding diary.
- A significant decrease in large volume urgency-related leaks, one of the most debilitating symptoms of UUI, from 0.9/day to 0.1/day.
- An excellent safety profile, with no (0%) device- or procedure-related serious adverse events, no device migrations, and no need for device revisions.
“What sets Revi apart is its patient centricity. The system allows patients to tailor treatment intervals to their symptoms and providers to individualize treatment plans to each patient,” said John Heesakkers, M.D., Chairman of the Department of Urology of the Maastricht University Medical Center in the Netherlands. “It is encouraging to see that the OASIS study long-term data continues to validate the Revi System as a durable and effective treatment for UUI.”
“The two-year study results affirm the Revi System’s significant impact in improving OAB and UUI symptoms and underscore its innovation and effectiveness as a minimally invasive neuromodulation option,” said Roger Dmochowski, M.D., Chief Medical Advisor, BlueWind Medical. “Our commitment remains steadfast to enhancing treatment options and elevating the quality of life for people grappling with UUI.”
As per DelveInsight’s “Neuromodulation Devices Market Report,” the neuromodulation devices market was valued at USD 5.71 billion in 2023, growing at a CAGR of 8.95% during the forecast period from 2024 to 2030 to reach USD 9.56 billion by 2030. The demand for neuromodulation devices is primarily driven by the growing prevalence of neurological disorders and the increasing number of patients suffering from chronic pain. Additionally, increasing research and development activities, along with collaborations among key players, are significantly contributing to market growth. The rising aging population further compounds this demand, as older adults are more susceptible to neurological conditions and chronic pain. These factors collectively position the neuromodulation devices market for positive growth during the forecast period from 2024 to 2030.
Reprieve Cardiovascular Announced Positive Results from FASTR Pilot Trial and FDA Investigational Device Exemption Approval for Pivotal Trial
On 16, February 2025, Reprieve Cardiovascular, Inc., a development-stage company dedicated to advancing treatment for acute decompensated heart failure (ADHF), announced topline results from its FASTR randomized pilot study. The study evaluated the Reprieve System in ADHF patients compared to optimal diuretic therapy (ODT) and successfully met both primary efficacy and safety endpoints. James Udelson, M.D., Principal Investigator of the FASTR trial and Chief of Cardiology as well as Interim Chief Physician Executive of the CardioVascular Center at Tufts Medical Center, presented the findings during the Late-Breaking Clinical Science session at the Technology and Heart Failure Therapeutics (THT) Annual Meeting in Boston, Massachusetts. Additionally, the company announced it has received FDA approval to launch an investigational device exemption (IDE) study, the FASTR II randomized pivotal trial, in the United States and Europe.
In patients with ADHF and substantial fluid volume overload, the Reprieve System, compared to ODT, demonstrated:
- Significantly higher sodium excretion (p<0.001), total urine output (p<0.001), and weight loss (p=0.002).
- No increase in decongestion-related adverse events, with a trend toward fewer elevations in serum creatinine during treatment.
- A reduced incidence of mortality and hospital readmissions.
“Results from the FASTR trial reinforce the potential of the Reprieve System to transform ADHF treatment by delivering more effective decongestion—enabling greater sodium, fluid, and weight loss—while preserving kidney function. The trial demonstrated the Reprieve System’s ability to safely and precisely remove fluid and sodium, reducing the risks of kidney injury often seen with diuretic therapy only,” said Dr. Udelson. “Importantly, treatment with the Reprieve System was associated with an early signal of a potential reduction in death or need for heart failure readmission in the three months after discharge. If this is further proven in our upcoming larger trial, it would be very impactful and further validate its potential to completely shift the treatment paradigm in ADHF.”
Designed to personalize decongestion management, the Reprieve System aims to safely, efficiently, and thoroughly remove excess fluid to enhance patient outcomes and reduce hospital readmissions. It facilitates fluid and sodium removal by precisely administering diuretics, rapidly determining the optimal dose, and replenishing the body with saline to support kidney function. The system uniquely integrates real-time physiological monitoring with automated recommendations for adjusting or discontinuing therapy, allowing physicians to tailor treatment to each patient’s needs. This innovative approach is designed to seamlessly fit into existing clinical workflows, optimize patient care, and ease the burden on clinicians managing heart failure patients.
“The FASTR pilot trial represents an important step forward in our clinical efforts and our commitment to achieving better outcomes for ADHF patients through intelligent decongestion management,” said Mark Pacyna, Chief Executive Officer of Reprieve Cardiovascular. “These results, from one of the few randomized pilot studies in the space, further demonstrate the potential of the Reprieve System to transform ADHF care for patients around the world. With FDA approval to start the FASTR II randomized pivotal trial, which we will initiate in the first half of this year, we’re excited to begin the next phase of Reprieve’s development. Thank you to all our clinical partners around the world for their continued support in advancing this technology.”
According to DelveInsight’s “Congestive Heart Failure Treatment Devices Market Report”, the congestive heart failure (CHF) treatment devices market was valued at USD 17.41 billion in 2023, growing at a CAGR of 8.26% during the forecast period from 2024 to 2030 to reach USD 27.96 billion by 2030. The congestive heart failure (CHF) treatment devices market is observing substantial market growth primarily owing to the increasing cases of cardiovascular disorders including atrial fibrillation and coronary artery disease (CAD), innovative product developmental activities by regulatory bodies, and the rising geriatric population that is expected to escalate the overall growth of the congestive heart failure (CHF) treatment devices market during the forecast period from 2024 to 2030.
