Aurie Wins FDA De Novo Grant for Innovative Reusable Urinary Catheter Technology; Biozen Secures FDA Clearance for Calibration-Free Cuffless Blood Pressure Technology; plusOne® Expands Wellness Care Portfolio with New Menopause and Fertility-Friendly Lubricants; TrilliumBiO and Oncobit Introduce Advanced Uveal Melanoma Monitoring Solution in the U.S.; Renerva Announces First-in-Human Implant of PNM-CAP™ for Neuroma Pain; SonoClear AS Announces Completion of Clinical Enrollment for Breakthrough Device-Designated SonoClear® System

Aurie Received FDA De Novo Grant for First Automated Safely Reusable Intermittent Urinary Catheter System

On 11 May 2026, Aurie announced that its Aurie Reusable No-Touch Intermittent Catheter System™ had received marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De Novo pathway. This approval established it as the first reusable intermittent urinary catheter system and created a new device classification in a market that had relied exclusively on single-use catheters for decades. The company stated that the Aurie System was expected to be launched in Veterans Health Administration spinal cord injury hospitals later that year.

The Aurie System comprised a 100-use no-touch intermittent catheter, a portable catheter washer-disinfector, and pre-packaged supply pods. It delivered the benefits of single-use no-touch catheter features at a lower cost. Extensive testing, including microbiological and human factors evaluations, demonstrated reasonable assurance of safety and effectiveness for its intended use and set a benchmark for future reusable catheter systems.

“Aurie is addressing the industry’s biggest challenge by combining sustainability and user-centered design to define a new standard of care. The De Novo clearance is a major milestone, and I’m excited to work with this team as they take the business to the next level,” said Manu Varma.

As per DelveInsight’s “Intermittent Urinary Catheters Market Report,” the intermittent urinary catheters market was valued at USD 2,492.18 million in 2024, growing at a CAGR of 5.77% during the forecast period from 2025 to 2032 to reach USD 3,894.60 million by 2032. The intermittent urinary catheters market is experiencing strong and steady growth, primarily due to the rising instances of neurologic bladder disorders such as multiple sclerosis, spinal cord injuries, and Parkinson’s disease, which often lead to impaired bladder function. In addition, the increasing number of individuals suffering from urinary retention, coupled with a growing elderly population prone to age-related urological conditions, is further boosting the demand for effective bladder management solutions. These factors, combined with advancements in catheter technology and a shift toward minimally invasive care, are expected to significantly escalate the demand for intermittent urinary catheters during the forecast period from 2025 to 2032.

Biozen Received FDA Clearance for Calibration-Free Cuffless Blood Pressure Technology 

On 11 May 2026, Biozen announced that its BP1000 had received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making it the first cuffless blood pressure device in the United States to deliver calibration-free, clinically validated spot measurements from the fingertip.

Cuffless blood pressure monitoring had long been a key focus in health technology, with both established device manufacturers and startups investing in its development for over a decade. The BP1000 was developed following extensive engineering, clinical research, and validation efforts to achieve this milestone. The device applied the same underlying principles as automated cuffs but measured blood pressure through the fingertip instead of using an inflatable arm cuff.

It operated by combining proprietary pressure sensing with photoplethysmography (PPG) to detect changes in blood volume and accurately identify arterial occlusion. Users applied gradual pressure while following guidance in a companion app, which recorded and displayed measurement history. Because the device directly measured physiological signals rather than relying on indirect estimation, it eliminated the need for per-user calibration against a traditional cuff, addressing a major limitation of earlier cuffless technologies. 

“We’ve spent years proving that accurate blood pressure measurement doesn’t require a cuff,” said Dikran Tourian, Chief Executive Officer of Biozen. “Nearly half of U.S. adults have hypertension, yet for most people, measurement still happens only occasionally. FDA clearance allows us to begin making routine, clinically validated spot blood pressure measurement far more accessible.”

As per 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.

plusOne® Expanded Wellness Care Collection with New Lubricants Designed for Menopause Support and Fertility-Friendly Intimacy

On 13 May 2026, plusOne® announced that it had expanded its Wellness Care Collection with the launch of two new purpose-driven lubricants designed to support women across different life stages, including menopause and fertility.

The company introduced a Menopause Lubricant aimed at alleviating vaginal dryness associated with menopause, and a Fertility-Friendly Lubricant formulated with optimized pH levels to support a sperm-friendly environment during conception. These products were developed in response to increasing awareness and more open conversations around women’s health needs that had historically been under-addressed.

Both formulations were made with clean, plant-based ingredients and excluded hormones, parabens, sulfates, and artificial dyes. Through this expansion, plusOne emphasized a broader, more holistic approach to intimate wellness, focusing on both physical comfort and emotional well-being. The products were made available through the company’s website and select retail channels nationwide.

“Women’s wellness needs shift dramatically across life stages. What supports you while trying to conceive looks different from what supports you through menopause,” said Maria Warrington, CEO of Beacon Wellness Brands. “We’re committed to meeting women in those specific moments with products that are accessible, effective, and designed for how their bodies actually feel.”

As per DelveInsight’s “Women’s Health Market Report,” the global women’s health market was valued at USD 31.94 billion in 2023, growing at a CAGR of 5.40% during the forecast period from 2024 to 2030 to reach USD 43.76 billion by 2030. The women’s health market is slated to witness prosperity owing to factors such as the growing prevalence of breast cancer, further rise in menstrual disorders and infertility issues in women, and the growing focus on improving the safety, affordability, and usability of women’s health products are further expected to result in the appreciable revenue growth in the women’s health market during the forecast period from 2024 to 2030.

TrilliumBiO and Oncobit Launched Advanced Uveal Melanoma Monitoring Solution in the U.S. 

On 12 May 2026, TrilliumBiO and Oncobit announced the launch of Oncular™, bringing Oncobit’s uveal melanoma monitoring solution to the United States through TrilliumBiO’s multi-accredited laboratory. The assay expanded access to advanced molecular testing for patients with uveal melanoma, a rare and historically underserved cancer.

Oncular™ introduced Oncobit’s proprietary platform for personalized cancer monitoring to physicians nationwide, enabling real-time, quantitative assessment of circulating tumor DNA (ctDNA) through a simple blood draw. It was designed to complement conventional imaging methods by providing precise insights into disease progression and supporting informed patient management across the care continuum.

The assay combined personalized digital PCR with standardized, cloud-based data analysis to deliver sensitive and reproducible molecular results. This approach addressed key limitations of traditional monitoring methods, such as low sensitivity, delayed detection of disease progression, high costs, and invasive procedures. It was also designed to be time- and cost-efficient while remaining scalable for routine clinical use.

Oncular™ provided insights including molecular residual disease (MRD) status, longitudinal ctDNA trends, and early molecular signals of treatment response or disease progression, often ahead of radiographic detection. Clinical research had demonstrated that ctDNA dynamics measured using Oncobit’s platform could predict treatment response and disease progression in metastatic uveal melanoma, highlighting the clinical relevance of this testing approach.

“Launching Oncular™ in the U.S. reflects our commitment to translating innovative science into high-quality diagnostic solutions for patients with rare diseases,” said Laura Vivian, CEO of TrilliumBiO. “By making this assay available through our laboratory, we are helping clinicians access reliable insights to better understand disease behavior and support patient care.”

According to DelveInsight’s “Liquid Biopsy In Cancer Diagnostics Market Report”, the global liquid biopsy in cancer diagnostics market was valued at USD 7.64 billion in 2024, growing at a CAGR of 16.64% during the forecast period from 2025 to 2032 to reach USD 19.24 billion by 2034. Factors such as the rising incidence of various cancers, growing demand for minimally invasive procedures, increasing demand for precision medicine, and technical innovation in product development, among other factors, are expected to drive the liquid biopsy in cancer diagnostics market.

Renerva Achieved First-in-Human Implant of PNM-CAP™ Device for Neuroma Pain 

On 13 May 2026, Renerva, Inc. announced that the first patient had been implanted in its first-in-human clinical study of the Renerva PNM-CAP™ device. The procedure was conducted at The Ohio State University Wexner Medical Center under the leadership of Amy M. Moore, who served as the principal investigator.

The Renerva PNM-CAP™ was an investigational nerve capping device designed to prevent disorganized nerve growth (neuroma) and the associated neuropathic pain in cases where functional recovery of a severed nerve was not possible or desired. Neuromas had been recognized as a major cause of chronic, severe pain in amputees and other patients with nerve injuries, often resulting in reduced quality of life and dependence on opioid-based pain management.

The initiation of this first-in-human study marked an important step in advancing clinical solutions aimed at addressing unmet needs in nerve injury treatment and chronic pain management.

“Transitioning to a clinical-stage company with the implantation of our first patient is a monumental milestone,” said Lorenzo Soletti, CEO of Renerva. “Our team has executed effectively, moving from FDA Investigational Device Exemption approval of the study to first-in-human implantation in just a few months. We are preparing for regulatory clearance and commercial launch, allowing us to bring this much-needed technology to patients and establish a new standard of care.”

According to DelveInsight’s ”Neuromodulation Devices Market Report,” the global neuromodulation devices market is expected to increase from USD 7,862.04 million in 2024 to USD 16,111.10 million by 2032, growing at a CAGR of 9.44% during the forecast period from 2025 to 2032. The market for neuromodulation devices is growing rapidly, fueled by the rising global prevalence of chronic diseases like pain, epilepsy, and depression. This growth is also driven by significant technological advancements that have made devices smaller, smarter, and more effective. Favorable regulatory policies and better reimbursement coverage are also making these treatments more accessible. Overall, the increasing demand for effective, long-term therapeutic options for neurological and chronic conditions is creating a strong and sustained market.

SonoClear AS Completed Clinical Enrollment for Breakthrough Device-Designated SonoClear® System 

On 12 May 2026, SonoClear AS announced that the final clinical procedure had been completed in its study evaluating the SonoClear System for use in intracranial ultrasound procedures in patients with neurological tumors. The company stated that it was proceeding with data analysis and preparing for submission for marketing clearance to the U.S. Food and Drug Administration (FDA).

The SonoClear System included an acoustic coupling fluid designed to enhance intraoperative imaging during neurosurgical procedures. It had been developed to address limitations associated with conventional irrigation fluids, which often created acoustic artifacts that obscured tumor remnants and complicated complete tumor resection.

The study assessed the safety and performance of the system in routine intraoperative ultrasound use, comparing it with standard irrigation fluids. Clinical investigators reported that the system integrated well into existing surgical workflows and had the potential to improve image clarity at the resection site.

The SonoClear System had previously received Breakthrough Device designation from the FDA in July 2025. Completion of the clinical study marked a significant milestone toward potential market entry in the United States, with plans to submit a 510(k) application in the second half of 2026.

The system was described as a sterile, biocompatible, and bio-excretable ultrasound coupling fluid engineered to match the acoustic properties of brain tissue. By reducing imaging artifacts and enhancing visualization of the surgical cavity, it was expected to improve diagnostic accuracy, support more complete tumor removal, and potentially reduce the need for repeat surgeries.

According to DelveInsight’s “Intra Operative Imaging Market Report,”  the global intraoperative imaging market was valued at USD 2.10 billion in 2023, growing at a CAGR of 5.68% during the forecast period from 2024 to 2030, to reach USD 2.27 billion by 2030. The increase in demand for intraoperative imaging is primarily due to the rising prevalence of various disorders, such as spine disorders, neurological disorders, cardiac disorders, and others, that require surgery as one of the treatments. In addition, an increase in surgical volume, growing approval and product launches of various intraoperative imaging systems, and technological advancement in the product arena, among others, are expected to propel the global intraoperative imaging market during the forecasted period.