Leo Cancer Care Receives CE Mark Approval for Marie® Upright Radiotherapy System;  PorTal Access, Inc. Hits Critical Regulatory Benchmark with Flexi-Port™ 510(k) Submission; Araceli Biosciences Introduces Endeavor® Live Cell to Accelerate AI-Driven Drug Discovery Imaging; TrilliumBiO Partners with Oncobit to Launch Next-Generation Uveal Melanoma Monitoring Platform; Advita Ortho Reports First Clinical Application of Equinoxe® Scapula Reconstruction System; Implantica Announces Findings Supporting RefluxStop®’s Economic Advantage in GERD Treatment in Italy

Leo Cancer Care Secured CE Mark for Marie®, Advancing Upright Radiotherapy in Europe 

On 21 May 2026, Leo Cancer Care announced that its flagship upright radiotherapy system, Marie, had received CE marking approval, enabling commercial deployment across Europe. The approval marked a significant advancement in radiotherapy delivery and introduced upright treatment technology to the European market after gaining clinical momentum in the United States. The company stated that Marie® had redefined conventional radiotherapy practices by allowing patients to receive treatment in an upright position rather than lying flat. This patient-centered approach was designed to improve comfort, enhance treatment flexibility, and support advanced treatment modalities, including online adaptive therapy and arc therapy.

Leo Cancer Care explained that Marie® was the first beam-agnostic upright radiotherapy platform compatible with multiple particle therapy modalities, positioning it as a future-ready solution for next-generation cancer treatment. The company also noted that the system had the potential to simplify treatment room design, improve operational efficiency, and increase accessibility for healthcare institutions unable to implement traditional particle therapy systems.

The CE marking confirmed that Marie® met European standards for safety, performance, and clinical readiness following years of engineering, research, and collaboration with radiation oncology partners. Centre Léon Bérard continued its collaboration with Leo Cancer Care to focus on anatomical imaging and upright patient positioning using the system’s upright CT capabilities.

In addition, Centro Nazionale di Adroterapia Oncologica in Italy began preparations for the installation of the system, with plans to commence patient treatments before the end of the year. The collaboration aimed to integrate upright positioning technology with advanced ion beam therapy to improve treatment precision, clinical throughput, and personalized cancer care. Following regulatory approval, Leo Cancer Care stated that it had been working with leading cancer centers across Europe to accelerate the adoption of upright radiotherapy solutions focused on both treatment precision and patient comfort.

“This is more than a regulatory milestone – it marks the moment upright radiotherapy becomes a clinical reality for patients in Europe,” said Stephen Towe, CEO of Leo Cancer Care, “Marie® redefines what’s possible in cancer treatment, combining human-centred design with the flexibility to support both current and emerging treatment modalities.”

As per DelveInsight’s “Radiotherapy or Radiation Oncology Devices Market Report,” the global radiotherapy/radiation oncology devices market is projected to grow at a 7.78% CAGR during the forecast period (2024 to 2030). The Radiotherapy/Radiation Oncology Devices market is witnessing positive growth owing to the factors such as the rising cases of various cancers, further rapid technological developmental activities, strong R&D initiatives from key players, rising adoption of radiotherapy procedures in cancer treatment, growing demand for minimally invasive procedures, thereby contributing to the growth of the Radiotherapy/Radiation Oncology Devices market during the forecast period from 2024 to 2030.

PorTal Access, Inc. Announced the Completion of FDA 510(k) Submission for Flexi-Port™, Marking Major Milestone Toward Commercial Launch

On 18 May 2026, PorTal Access announced the successful completion of its U.S. FDA 510(k) submission for its flagship vascular access device, Flexi-Port. The company stated that the submission marked an important regulatory milestone toward commercialization as it prepared for a planned mid-summer product launch. According to the company, the Flexi-Port™ had been developed to improve vascular access port placement workflows through its unique flexible design and implantation approach. The device featured the only flexible port currently available on the market and required one of the smallest surgical incisions among comparable vascular access ports.

Clinical experts also expressed optimism regarding the technology’s potential impact. Anne Covey noted that the device design could positively influence patients’ emotional well-being through improved aesthetics, comfort, and a lower device profile, especially for individuals undergoing long-term venous therapy. The company further explained that Flexi-Port™ reflected its broader commitment to improving vascular access technology by enabling a streamlined, minimally invasive placement process while enhancing overall patient experience and procedural efficiency.

“This is a defining moment for PorTal Access and a testament to the dedication of our clinical, engineering, and leadership teams,” said Angela Dotson, COO and Head of Business Development at PorTal Access, Inc. “Completing our FDA 510(k) submission brings us one step closer to delivering a differentiated solution designed to prioritize patient satisfaction, clinician ease-of-use, and clinician workflow. We are excited about the impact Flexi-Port™ will have on the future of vascular access and IR.”

As per DelveInsight’s “Interventional Radiology Devices Market Report,” the global interventional radiology devices market is expected to grow at a CAGR of 5.23% during the forecast period of 2021-2030. The increase in demand for interventional radiology devices is primarily attributed to the increasing patient pool due to an increasing prevalence of chronic disorders & cancer, and due to the increasing number of geriatric patients globally. The interventional radiology devices work on minimally invasive techniques, so it involves less severe surgical procedures, thereby leading to less hospitalization period. Thus, the rising demand for reducing healthcare expenditure across the world is anticipated to bolster the market for these devices. Furthermore, the rising awareness and demand for minimally invasive techniques and the technological advancements in devices such as illumination rendering technology, real-time images, and others across the world are anticipated to bolster the market, thereby contributing to the growth of the interventional radiology devices market during the forecast period from 2024 to 2030.

Araceli Biosciences Launched Endeavor® Live Cell for Ultra-High-Throughput Kinetic Imaging in AI-Driven Drug Discovery 

On 20 May 2026, Araceli Biosciences announced the launch of Endeavor Live Cell, expanding its ultra-high-throughput imaging technology into dynamic biology applications at the screening scale. The company stated that, as AI-driven drug discovery workflows are increasingly adopted, Lab-in-the-Loop approaches require researchers to require more than traditional endpoint measurements. Scientists needed high-quality cellular imaging data that could be generated rapidly, consistently, and at a large scale. Endeavor® Live Cell was developed to address this demand by enabling rapid kinetic imaging across entire 1536-well plates, allowing researchers to observe cellular biology in real time.

The system enabled imaging timepoints of approximately four minutes across the full 1536-well plates. This capability allowed live cell and kinetic biology studies to be integrated into ultra-high-throughput workflows, where timing precision, plate-wide consistency, and automation compatibility were critical for connecting experimentation, analysis, and decision-making processes.

According to the company, the platform supported applications involving rapidly changing cellular behavior, including compound response analysis, cell health and viability monitoring, phenotypic screening, organoid and spheroid growth tracking, and other kinetic assays requiring frequent large-scale imaging timepoints. The system was developed through a partnership with Okolab, combining Okolab’s expertise in live cell incubation and environmental control with Araceli Biosciences’ ultra-high-throughput imaging capabilities.

As per DelveInsight’s “Artificial Intelligence (AI) In Drug Discovery Market Report,” The global Artificial Intelligence (AI) in drug discovery market is expected to increase from USD 2,092.01 million in 2024 to USD 18,634.45 million by 2032, growing at a CAGR of 31.48% during the forecast period from 2025 to 2032. The global Artificial Intelligence (AI) in drug discovery market is being driven by the rising prevalence of chronic diseases and the growing efficiency that AI brings to drug development. Advances in big data analytics and precision medicine enable AI to deliver faster, more targeted, and cost-effective drug discovery solutions. Additionally, the increasing use of AI for repurposing existing drugs is reducing R&D timelines and boosting innovation across the pharmaceutical sector.

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 has 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.

Advita Ortho Announced First Clinical Use of Equinoxe® Scapula Reconstruction System 

On 20 May 2026, Advita Ortho announced the first clinical use of its Equinoxe Scapula Reconstruction System, the first dedicated trauma solution specifically developed to treat acromial and scapular spine fractures and non-unions, including fractures associated with reverse shoulder arthroplasty. The initial surgeries were performed by design team surgeons Michael McKee and Peter Cole.

The company noted that acromial and scapular spine fractures, although relatively uncommon, had been severe postoperative complications following reverse shoulder arthroplasty and that limited treatment options had previously been available. These fractures could also occur in patients with cuff tear arthropathy and other trauma-related injuries outside arthroplasty procedures.

The Equinoxe® Scapula Reconstruction System featured low-profile, anatomically pre-contoured implants designed to fit the anterior and lateral acromion while minimizing disruption to the deltoid muscle. The system also included specialized lateral, medial, and anterior hook plate configurations intended to support the scapula, counteract deltoid tensile forces, and provide multiplanar fixation for complex fracture patterns while reducing the need for intraoperative implant bending.

“I am proud to be among the earliest to use the Equinoxe Scapula Reconstruction System,” said Dr. McKee. “This is a meaningful advancement for a complication that has historically been difficult to treat. Having implants designed specifically for these fracture patterns, while accounting for the biomechanics of reverse shoulder arthroplasty, gives surgeons new confidence in managing these challenging cases.”

According to DelveInsight’s ”Trauma Fixation Devices Market Report,” the global trauma fixation devices market is expected to increase from USD 8,073.28 million in 2024 to USD 12,795.77 million by 2032, growing at a CAGR of 6.01% during the forecast period from 2025 to 2032. The market of trauma fixation devices is being primarily driven by the rising incidence of road accidents and trauma cases, the increasing number of orthopedic surgeries, technological advancements in product designs, and an increase in product development activities among the key market players.

Implantica Announced Publication of a New Health Economics Study Showing Refluxstop®’S Superior Cost-Effectiveness in the Treatment of GERD in the Italian Healthcare System 

On 21 May 2026, Implantica AG announced that a new study had demonstrated that its innovative GERD treatment device, RefluxStop, was highly cost-effective compared to conventional GERD treatments within the Italian healthcare system. The study, titled “Cost-effectiveness of RefluxStop for gastroesophageal reflux disease: analysis from an Italian healthcare perspective,” was conducted by the York Health Economics Consortium in collaboration with leading Italian anti-reflux surgeons and was published in BMC Gastroenterology.

The health-economic analysis showed that RefluxStop® had a 100% probability of being cost-effective compared with proton pump inhibitors (PPIs) and magnetic sphincter augmentation (MSA), along with a 97% probability compared with Nissen fundoplication in Italy’s healthcare system. The company also reported that more than 200 procedures had already been completed, while increasing approvals of public tenders across Italy had strengthened the commercial adoption of RefluxStop®. The positive reimbursement outlook in Italy was expected to support wider adoption across other European healthcare markets as well.

Inventor of RefluxStop® and CEO of Implantica, Dr. Peter Forsell says, “The basis for a successful launch of a new treatment always depends on good or superior clinical results; however, the power of having the most cost-effective treatment should not be underestimated. Italy is a good example where health economics, with RefluxStop being the most cost-effective treatment available, goes hand in hand with securing procurement in the public healthcare system. We are grateful to the independent surgeons who choose to collect and publish RefluxStop® data, driving surgical innovation forward for GERD patients everywhere.”According to DelveInsight’s “Gastroesophageal Reflux Disease (GERD) Devices Market Report,” the global gastroesophageal reflux disease (GERD) devices market is estimated to grow at a CAGR of 9.20% during the forecast period. The demand for gastroesophageal reflux disease (GERD) devices is primarily being boosted by the rising number of patients suffering from obesity owing to the sedentary lifestyle, increasing technological advancements associated with the GERD devices, and the rising geriatric population susceptible to developing the GERD disorder, contributing to the overall market growth of the gastroesophageal reflux disease (GERD) Devices during the forecast period from 2024 to 2030.