Multi4 Medical Gains CE Mark Approval for Office-Based Bladder Cancer Treatment; FX Shoulder Solutions Achieves FDA 510(k) Clearance for FX V135® Easytech Platform; Ortho Development Launches Commercial Rollout of Trivicta® Hip Stem; Clover Podiatry Expands Foot and Wound Care Services With New Advanced Healing Center; CLiMB Study Highlights Superior Sensitivity of HelioLiver™ Blood Test Versus Ultrasound in Detecting Early-Stage HCC; Aqua Medical Unveils Promising DDW 2026 Data Showing Sustained Insulin Elimination in Type 2 Diabetes Patients

Multi4 Medical Received CE Mark – Moves Bladder Cancer Treatment from Operating Room to Outpatient Setting

On 05 May 2026, the CE mark enabled the Multi4 System to be commercialized across Europe and represented a major advancement in urologic cancer care. The system introduced the world’s first all-in-one instrument, enabling urologists to perform the complete treatment endoscopically in awake patients. Procedures that traditionally required scheduled surgery and general anesthesia were completed within minutes during routine office visits.

The Multi4 instrument integrated several functions into a single platform. It delivered local anesthesia directly to the tumor site, precisely resected cancer tissue, automatically transported tissue samples through the device into a pathology collection container, and enabled cauterization and bleeding control when necessary. Patients remained awake throughout the procedure and were discharged immediately afterward without requiring general anesthesia, catheterization, or hospital admission.

Compared with the conventional TURBT procedure, which depended on operating room availability and anesthesia scheduling, the Multi4 treatment was performed immediately after tumor detection. This reduced patient waiting times, lowered the burden on hospital operating departments, and decreased treatment costs for healthcare providers. The availability of an established reimbursement code further supported the adoption and implementation of the system across healthcare facilities.

“The CE mark is a historic milestone for Multi4 Medical and for cancer care in Europe. The Multi4 instrument integrates all necessary functions into a single compact device and is the first system where cancer tissue is automatically transported out through the instrument itself and captured in a container. This makes treatment streamlined, safe, and feasible in an outpatient setting,” says Miden Melle-Hannah, urologist and CEO of Multi4 Medical.

As per DelveInsight’s “Urology Devices Market Report,” the global urology devices market is expected to increase from USD 34,898.97 million in 2024 to USD 63,320.19 million by 2032, growing at a CAGR of 7.77% during the forecast period from 2025 to 2032. The global urology devices market is growing due to the rising prevalence of kidney stones, urinary incontinence, BPH, and prostate and bladder cancers, particularly among the aging population. Advancements in minimally invasive and robotic-assisted procedures, along with improved diagnostics, are boosting adoption. Additionally, increasing healthcare spending, expanding infrastructure in emerging economies, and rising lifestyle-related risk factors such as obesity and diabetes are further driving market demand.

FX Shoulder Solutions, Inc. Received FDA 510(k) Clearance for FX V135® Easytech Shoulder System 

On 05 May 2026, FX Shoulder Solutions, Inc. received FDA 510(k) clearance for the FX V135® Easytech Shoulder System, a next-generation stemless shoulder arthroplasty platform designed to provide surgeons with both anatomic stemless and modular stemmed-reverse treatment options. The innovative design allowed surgeons to begin procedures with a stemless approach and transition intraoperatively to a short stem solution when clinically necessary without switching to another implant system.

The FX V135® Easytech Shoulder System utilized a single humeral tray to support the entire workflow, reinforcing the company’s long-standing focus on minimal instrumentation and surgical efficiency. The system featured a unique modular construct that combined a stemless anchor base with a removable stem adaptation integrated into one humeral platform, making it the only system of its kind available in the United States.

The system was offered in an anatomic stemless configuration with an optional short stem conversion, as well as a reverse configuration with a short stem option. Both configurations operated at 135°, while the reverse option additionally supported a 145° configuration. Multiple anchor base sizes ranging from 32 mm to 44 mm and an 8 mm humeral stem adaptation enhanced surgical flexibility. The platform was also compatible with previously approved humeral head, glenoid, glenosphere, and baseplate options.

The FX V135® Easytech system further advanced the existing FX V135® platform by introducing centered humeral cup tapers, a new +1 mm humeral cup option, and improved intraoperative soft tissue tensioning capabilities. These enhancements improved surgical precision and adaptability during procedures. The company stated that the system strengthened its shoulder arthroplasty portfolio across stemless, primary, fracture, and revision solutions while continuing its focus on innovation driven by surgeon feedback and improved patient outcomes. 

“This clearance represents a significant step forward in our mission to simplify complexity without limiting surgeon choices,” said Baptiste Martin, CEO of FX Shoulder Solutions. “FX V135® Easytech is designed to give surgeons the flexibility to adapt in real time moving from stemless to stemmed fixation within a single system while maintaining the efficiency of a single-tray solution which allows an easy adaptation to ASC market. This is a continuation of what has defined FX since the beginning: purposeful innovation that respects both surgical workflow and patient-specific needs. It is the continuation of our new generation FX V135® portfolio.”

As per DelveInsight’s “Shoulder Replacement Devices Market Report,” the shoulder replacement devices market was valued at USD 1.68 billion in 2023, growing at a CAGR of 7.27% during the forecast period from 2024 to 2030, to reach USD 2.54 billion by 2030. The shoulder replacement devices market is experiencing significant growth owing to the widespread instances of shoulder injuries and degenerative conditions like osteoarthritis and rheumatoid arthritis, the rise in product development & innovation activities, among others that are acting as key factors, contributing to the market growth of the shoulder replacement devices market during the forecast period from 2024 to 2030.

Ortho Development Announced Full Commercial Launch of Trivicta® Hip Stem 

On 04 May 2026, Ortho Development Corporation (ODEV), a manufacturer of orthopedic implants and surgical instruments, announced the full commercial launch of the Trivicta® Hip Stem, a cementless triple-taper femoral component developed for primary total hip arthroplasty procedures. After an initial controlled market release, the system became commercially available across the United States through the company’s authorized distribution network.

The Trivicta® Hip Stem expanded Ortho Development’s hip reconstruction portfolio by introducing a refined femoral stem engineered to improve implant stability, surgical versatility, and procedural efficiency. The implant incorporated a complete 35 μm hydroxyapatite coating over sintered titanium beads to promote early osteointegration and long-term fixation. The system also included standard and extended offset options that enabled direct lateralization without altering patient leg length.

The design featured progressive neck lengths and optimized distal geometry to accommodate a broad range of femoral anatomies. In addition, the system utilized a hybrid broach design with integrated anterior and posterior compaction teeth intended to preserve bone while enhancing implant seating accuracy. Modular instrumentation and incremental stem sizing were introduced to simplify surgical preparation and minimize variability in implant placement across different surgical approaches.

“Trivicta represents an important milestone for Ortho Development and reflects the collaboration, clinical insights and engineering discipline behind its development and launch,” said Greg Larson, President of Ortho Development. “Feedback from the early market release has reinforced our confidence in the system and its thoughtful refinement of the proven triple-taper design.”

As per DelveInsight’s “Hip Reconstruction/Replacement Devices Market Report,” the global hip reconstruction/replacement devices market is expected to increase from USD 9,254.50 million in 2025 to USD 14,917.71 million by 2034, growing at a CAGR of 5.51% during the forecast period from 2026 to 2034. The global hip reconstruction and replacement devices market is growing rapidly due to the rising prevalence of bone-related disorders, increasing hip fracture cases, and continuous technological advancements. Conditions like osteoarthritis and osteoporosis are driving the need for effective joint restoration solutions, while the surge in age-related fractures further boosts surgical demand. In parallel, innovations such as 3D-printed implants, hybrid fixation systems, and robotic-assisted procedures are enhancing implant performance and surgical precision. Together, these factors are propelling market expansion and reinforcing the critical role of hip reconstruction/replacement devices in modern orthopedic care.

Clover Podiatry Launched Advanced Wound Care Center in Vancouver, WA, Expanding Access to Innovative Healing Technologies 

On 05 May 2026, Clover Podiatry launched the Clover Wound Care Center in Salmon Creek to provide advanced treatment solutions for chronic and non-healing lower extremity wounds across the Vancouver and Southwest Washington region. The newly established center focused on treating diabetic ulcers, venous wounds, post-surgical complications, and other complex wounds using minimally invasive and regenerative treatment technologies.

The center was established in response to the growing burden of chronic wounds, which affect millions of patients and can lead to severe complications such as infections, hospitalization, and amputations when left untreated. By offering multiple advanced therapies under one facility, the center aimed to improve access to specialized wound care services that are often unavailable in traditional outpatient settings.

Among the technologies introduced at the center was non-contact ultrasonic debridement, which utilized ultrasound and water vapor to clean wounds without direct contact or the discomfort associated with conventional surgical debridement methods. The facility also implemented Vaporox therapy as an alternative to traditional hyperbaric oxygen treatment, enabling patients to undergo shorter and less frequent therapy sessions while still enhancing oxygen delivery and wound healing.

In addition, the center incorporated shockwave therapy and deep tissue laser therapy to stimulate circulation, reduce inflammation, and support tissue regeneration in chronic wounds. Clover Wound Care also offered regenerative treatment options such as platelet-rich plasma (PRP) wound gel, which used the patient’s own blood-derived growth factors to accelerate tissue repair and improve healing outcomes.

For more severe and treatment-resistant wounds, the center provided skin grafting procedures combined with advanced wound therapies to promote recovery. The clinic became one of the few facilities on the U.S. West Coast offering several of these specialized wound care technologies, strengthening its position in advanced lower extremity wound management.

“CentroVena One™ represents the most meaningful advancement in central line insertion since the technique was first introduced nearly seven decades ago,” said Ron Silverman, executive vice president and chief medical officer at BD. “By reducing procedural steps, helping protect against preventable complications and simplifying one of the most stressful procedures clinicians perform, we’re supporting safer, faster care for patients when every second counts.”

According to DelveInsight’s “Advanced Wound Care Market Report”, the advanced wound care market was valued at USD 9.45 billion in 2023, growing at a CAGR of 10.51% during the forecast period from 2025 to 2032, to reach USD 16.97 billion by 2032. The advanced wound care market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence, such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key market players, is expected to significantly drive the demand for advanced wound care from 2025 to 2032.

Landmark CLiMB Study Demonstrated Superior Sensitivity of HelioLiver™, a Multi-Analyte Blood Test, Over Ultrasound for Early Detection of Hepatocellular Carcinoma 

On 06 May 2026, Helio Genomics, an AI-driven TechBio company specializing in early cancer detection, announced the publication of a study in the Journal of Hepatology evaluating the performance of HelioLiver™, its multi-analyte noninvasive blood test designed for the early detection of hepatocellular carcinoma (HCC). The peer-reviewed study, titled “A Multi-Analyte cfDNA-based Blood Test for Early Detection of Hepatocellular Carcinoma,” presented findings from the CLiMB clinical trial and demonstrated the test’s effectiveness in identifying early-stage liver cancer in patients with cirrhosis.

The CLiMB trial represented the largest completed prospective, multicenter, blinded U.S. clinical study conducted for a liver cancer liquid biopsy test. The trial enrolled 1,968 patients with cirrhosis across 42 clinical centers, with 1,556 patients included in the validation cohort for direct comparison between HelioLiver™ and standard abdominal ultrasound screening methods. The study uniquely incorporated multiphasic MRI scans for all participants as the clinical reference standard to confirm the presence or absence of HCC.

HelioLiver™ combined cell-free DNA methylation signatures, serum protein biomarkers, and patient demographic information to improve liver cancer detection accuracy. The test achieved both pre-specified co-primary endpoints by demonstrating superior sensitivity and non-inferior specificity compared with abdominal ultrasound for HCC detection. It also met a secondary endpoint for improved detection of small liver tumors measuring 4 cm or less.

The study results showed that HelioLiver™ outperformed ultrasound in overall HCC detection, identifying 47.8% of cancer cases compared with 28.3% for ultrasound alone. The test showed particularly strong performance in detecting early-stage and small lesions, including lesions under 4 cm and tumors smaller than 2 cm. In patients with T1/stage I HCC, the blood test demonstrated significantly higher sensitivity than ultrasound. HelioLiver™ also maintained statistically non-inferior specificity while providing higher sensitivity than the combination of ultrasound and alpha-fetoprotein (AFP) testing, with a comparable negative predictive value.

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, technical innovation in product development, among other factors, are expected to drive the liquid biopsy in cancer diagnostics market.

Aqua Medical Highlighted 100% Insulin Elimination for 12 Months in Patients with Type 2 Diabetes with its Breakthrough “Through-the-Scope” Procedure at Digestive Disease Week® (DDW) 2026

On 05 May 2026, Aqua Medical, Inc., a company specializing in Endoscopic Metabolic Restoration technologies, presented 12-month follow-up clinical data at the 2026 Digestive Disease Week® (DDW) conference for its proprietary radiofrequency vapor ablation (RFVA) platform. The results highlighted the long-term potential of the company’s Proximal Intestinal Mucosal Ablation (PIMA) procedure as a minimally invasive treatment approach for patients with type 2 diabetes.

The clinical findings demonstrated sustained and clinically meaningful improvements in glycemic control across multiple patient groups, including individuals using oral diabetes medications, insulin-dependent patients, and patients previously treated with duodenal mucosal ablation therapies.

The PIMA procedure was delivered through Aqua Medical’s proprietary “through-the-scope” endoscopic platform, which eliminated the need for fluoroscopy and enabled integration into standard ambulatory surgical center workflows. The minimally invasive outpatient procedure was completed in approximately 60 minutes and demonstrated a favorable safety profile.

The 12-month study results showed reductions in HbA1c levels of up to 2.6% in treated patients. The therapy also enabled the complete elimination of exogenous insulin use in all treated insulin-dependent patients, while 80% of patients remained insulin-free without requiring additional medications.

The PIMA procedure utilized second-generation RF vapor ablation technology to target and ablate approximately 60 cm of proximal small intestinal mucosa. The therapy was designed to restore metabolic signaling pathways and address underlying insulin resistance rather than only managing blood glucose levels. The entirely endoscopic approach was performed through the working channel of a standard endoscope, supporting a single-session outpatient intervention without fluoroscopic guidance. 

“These one-year results reinforce the transformative potential of this approach,” said Dr. Rehan Haidry. “Achieving durable glycemic improvement with a minimally invasive, fully endoscopic procedure represents a significant advance in the treatment of Type 2 Diabetes.”

“These findings support the underlying hypothesis that targeting the proximal intestine can restore key metabolic pathways,” said Dr. Benjamin Norton. “The magnitude and durability of effect observed at 12 months are highly encouraging.”

“What makes this technology truly differentiated is its simplicity and scalability,” said Dr. Raj Nihalani, Chief Medical Officer, Aqua Medical, Inc. ” This is a proprietary, through-the-scope, minimally invasive procedure that requires no fluoroscopy and fits seamlessly into GI and endo-bariatric workflows bringing interventional solutions to a disease historically managed with chronic therapy escalation. PIMA procedure is for investigational use only, and is recruiting patients for its pilot study in the US.”

According to DelveInsight’s “Diabetes Care Devices Market Report,”  the global diabetes care devices market size is expected to increase from USD 40,781.76 million in 2025 to USD 76,404.07 million by 2034, growing at a CAGR of 7.26% during the forecast period from 2026 to 2034. The diabetes care devices market is primarily driven by the rising global prevalence of diabetes, fueled by increasing obesity rates, sedentary lifestyles, and aging populations. Growing awareness about early diagnosis and the importance of continuous glucose monitoring is boosting the adoption of advanced devices such as CGMs, insulin pumps, and smart insulin pens. Technological advancements, including digital connectivity, AI integration, and wearable solutions, are further enhancing patient convenience and treatment accuracy. Additionally, supportive reimbursement policies, expanding healthcare infrastructure, and increasing emphasis on self-management and home-based care are contributing to sustained market growth.