Olympus Secures FDA Clearance for POWERSEAL™ Open Extended Jaw Device; Abbott’s Ultreon™ 3.0 Receives FDA Clearance and CE Certification; LTS Broadens CDMO Capabilities with Ophthalmic Drug Delivery Expertise; BD Transforms Central Line Placement with Groundbreaking Technology; AI Models Deliver Up to 73% Fewer Genome Analysis Errors in New Research; Calidar Finishes Enrollment in First-in-Human Trial of 4D Mammography System

Olympus Received FDA Clearance for POWERSEAL™ Open Extended Jaw Device 

On 28 April 2026, Olympus Corporation announced that it had received 510(k) clearance from the U.S. Food and Drug Administration for its POWERSEAL™ Open Extended Jaw Sealer/Divider for use in open surgical procedures. The approval marked an expansion of the company’s advanced bipolar surgical energy portfolio, aimed at improving precision, efficiency, and control in surgical settings.

The POWERSEAL™ Open Extended Jaw Sealer/Divider had been cleared for use in the U.S. as part of the broader POWERSEAL portfolio, which already included three 5 mm devices with multiple jaw configurations and shaft lengths. These devices had been designed to accommodate various surgical techniques, including dissection, grasping, and vessel sealing, across both open and laparoscopic procedures.

The newly introduced device had enabled reliable sealing of vessels up to 7 mm in diameter, including pulmonary vessels, tissue bundles, and lymphatics. It had also featured multifunctional jaw capabilities that supported coagulation, cutting, atraumatic grasping, and dissection. Additionally, ergonomic improvements had been incorporated to reduce hand fatigue and enhance ease of use for surgeons.

Distinct features of the device included a proximally located rotation knob for single-handed operation, an increased range of rotation for improved control, and a specialized jaw coating designed to minimize tissue sticking. The instrument had been indicated for ligation and division of vessels and tissue bundles in open surgery and was intended for single-use only to prevent risks such as cross-contamination and device degradation.

“We are pleased to receive 510(k) clearance for the POWERSEAL™ Open Extended Jaw for open surgery, further expanding our advanced bipolar surgical energy portfolio,” said Glenn Thurlow, Vice President and Regional Business Unit Lead for Surgical Devices at Olympus Corporation of the Americas. “The POWERSEAL devices are designed to address physician needs for strong vessel sealing, procedural efficiency, and comfort in the operating room, supporting our ongoing commitment to advancing surgical performance and patient care.”

As per DelveInsight’s “Electrosurgical Devices Market Report,” the global electrosurgical devices market is expected to increase from USD 6,279.12 million in 2025 to USD 10,220.04 million by 2034, growing at a CAGR of 6.34% during the forecast period from 2026 to 2034. The global electrosurgical devices market is witnessing strong growth driven by the rising prevalence of chronic disorders, a steady increase in the volume of surgical procedures, and the growing preference for minimally invasive interventions that rely heavily on precise and controlled energy delivery. Continuous innovations in electrosurgical technologies, including safer energy modalities, improved thermal management, and smarter real-time feedback systems, are further accelerating product adoption. Together, these factors are directly expanding clinical utilization, strengthening technology upgrades, and reinforcing the overall demand trajectory of the market.

Abbott Received FDA Clearance and CE Mark for Next-Generation Ultreon™ 3.0 AI-powered Coronary Imaging Platform 

On 28 April 2026, Abbott Laboratories announced that it had received clearance from the U.S. Food and Drug Administration, along with CE Mark approval for its next-generation Ultreon™ 3.0 Software. The milestone had represented a significant advancement by integrating coronary imaging with artificial intelligence-driven insights into a single platform to improve patient outcomes and reduce procedural risks.

Ultreon 3.0 had functioned as an AI-powered imaging system utilizing optical coherence tomography (OCT) to provide real-time guidance during minimally invasive procedures such as percutaneous coronary intervention (PCI), which are performed to treat blocked coronary arteries. The system had enabled physicians to visualize detailed arterial structures and identify plaque characteristics, allowing them to determine the most appropriate stent size and placement for optimal blood flow restoration.

The platform had offered a fully integrated workflow designed to enhance procedural speed and precision. It had also introduced a one-second OCT pullback feature, a high-speed imaging technique using infrared light to generate detailed cross-sectional images of coronary arteries. This approach had delivered higher resolution imaging compared to intravascular ultrasound (IVUS) while requiring minimal or no contrast, which had been particularly beneficial for patients with kidney disease.

Furthermore, the software had provided enhanced AI capabilities, including improved visualization of blockage size, shape, and location, post-procedure assessment to evaluate stent effectiveness, and simplified workflow through automated insights. The system had also enabled efficient image acquisition and tailored procedural planning, especially for patients with complex coronary conditions.

“Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients. This next-generation platform, combining imaging and AI, doesn’t just improve upon existing technology; it leapfrogs it,” said Evan Shlofmitz, D.O., interventional cardiologist, director of interventional cardiology, St. Francis Hospital and Health Center in Roslyn, NY. “By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”

“Abbott’s Ultreon 3.0 offers a single, AI-driven platform that quickly and easily captures the images physicians need to fully understand the size and angle of the blockage, and create an actionable plan to help the patient,” said David M. Leistner, interventional cardiologist, Clinic for Cardiology and Angiology, Charité Campus Benjamin-Franklin (CBF) in Berlin, Germany. “Every second and every decision matters when treating patients who have blockages in their coronary arteries, and Ultreon 3.0 enables faster, more informed clinical choices that can have a real impact on patients.”

As per DelveInsight’s “Optical Coherence Tomography (OCT) Devices Market Report,” the global optical coherence tomography market was valued at USD 1.22 billion in 2023, growing at a CAGR of 8.57% during the forecast period from 2024 to 2030 to reach USD 2.00 billion by 2030. The optical coherence tomography devices market is moving towards a positive market growth owing to factors such as rising prevalence of ocular diseases, such as cataracts, growing number of cardiovascular diseases, such as myocardial infarction, increasing geriatric population across the globe, and increasing product development activities with respect to Optical Coherence Tomography Devices, among others.

LTS Expanded CDMO Portfolio with Ophthalmic Drug Delivery Solutions 

On 29 April 2026, LTS Lohmann Therapie-Systeme AG announced that it had expanded its service portfolio to include CDMO services for ophthalmic drug delivery solutions, with manufacturing operations based at its facility in Lakewood, New Jersey, in the United States.

The company had initially focused its new offering on product development through clinical-stage manufacturing of sterile ophthalmic products, particularly those filled in preservative-free multidose delivery systems. By leveraging its existing expertise in aseptic manufacturing for nasal sprays and vial-based products, LTS had positioned itself to meet stringent regulatory and quality requirements associated with ophthalmic therapies for both chronic and acute eye conditions.

Building on its long-standing experience in drug delivery technologies, LTS had outlined plans to extend its services toward full end-to-end CDMO capabilities, encompassing formulation development through to commercial-scale manufacturing. All operations had been designed to comply with global regulatory standards, enabling support for both U.S. and international markets.

The expansion had been aimed at serving pharmaceutical and biotechnology companies seeking a reliable U.S.-based partner for ophthalmic drug development and manufacturing. By integrating development expertise, sterile production infrastructure, and strong quality systems, LTS had intended to establish long-term partnerships across the entire product lifecycle.

This strategic move had reflected the company’s ongoing efforts to broaden its technological capabilities and address increasing demand for advanced drug delivery solutions in sensitive therapeutic areas such as ophthalmology.

“Ophthalmic drug delivery presents unique challenges in terms of sterility, efficacy, and patient safety,” said Bas van Buijtenen, CEO at LTS. Our aseptic manufacturing capabilities in Lakewood are the perfect foundation to build industry-leading CDMO capabilities and capacity for ophthalmics, powering the future of drug delivery in this field in North America. We look forward to extending our purpose – We CARE. We CREATE. We DELIVER -towards an even wider group of customers, therapies and patients.”

As per DelveInsight’s “Ophthalmic Devices Market Report,” the global ophthalmic devices market is expected to increase from USD 31,902.50 million in 2024 to USD 44,247.53 million by 2032, growing at a CAGR of 7.13% during the forecast period from 2025 to 2032. The global ophthalmic device market is witnessing robust growth, primarily driven by the rising incidence of eye disorders such as cataracts, glaucoma, age-related macular degeneration, diabetic retinopathy, and refractive errors. Factors such as aging populations, increasing prevalence of diabetes and hypertension, and greater exposure to digital screens are significantly contributing to the growing patient pool. This surge in eye-related conditions is fueling demand for advanced diagnostic, surgical, and vision correction devices, prompting continuous innovation and adoption of technologies like minimally invasive surgeries, laser systems, and AI-enabled diagnostics. Consequently, the escalating burden of eye diseases is a key catalyst shaping the expansion of the ophthalmic device market worldwide.

BD Reimagines Central Line Insertion, Advancing Leadership in Patient Safety Through Breakthrough Vascular Access Technology 

On 29 April 2026, Becton, Dickinson and Company announced the commercial launch of the BD® CentroVena One™ Insertion System, an all-in-one device designed for central venous catheter (CVC) placement. The system had been introduced as a novel solution aimed at simplifying central line insertion while enhancing patient safety and clinical efficiency in acute care environments.

The device had addressed longstanding challenges associated with traditional central line placement, which typically involved multiple component exchanges that could increase contamination risks, procedural delays, and complications such as infections, embolisms, and needlestick injuries. By integrating key components, including the introducer needle, syringe, guidewire, and catheter into a single platform, the system had streamlined the overall procedure.

Compared to conventional methods, the CentroVena One™ system had reduced workflow steps by approximately 30% and shortened insertion time by nearly 50%. It had also minimized touchpoints during the procedure, thereby lowering the risk of contamination and associated complications.

The system had incorporated several safety-focused features, such as a pre-loaded kink-resistant guidewire, an integrated drape clip to reduce the risk of guidewire embolism, and a pre-loaded catheter with a self-dilating tip that eliminated the need for a separate dilation step. Additional elements included an introducer needle with built-in passive safety to reduce needlestick injuries and a closed insertion system designed to limit air embolism, blood exposure, and patient blood loss.

The device had undergone early clinical evaluation at UNC Health Blue Ridge, where initial feedback highlighted its ability to streamline workflows and reduce procedural risks in high-acuity settings. Furthermore, the CentroVena One™ Insertion System had received U.S. FDA 510(k) clearance and had been accepted into the FDA’s Safer Technologies Program (STeP), recognizing its potential to advance patient safety through innovative design.

“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 “Vascular Access Devices Market Report”, the global vascular access device market is expected to increase from USD 5,450.01 million in 2024 to USD 8,413.65 million by 2032, growing at a CAGR of 6.40% during the forecast period from 2025 to 2032. The global vascular access device market is growing rapidly due to the rising prevalence of chronic diseases like cancer, kidney disorders, and cardiovascular conditions, which require long-term intravenous therapies. Advancements in device technology, including antimicrobial coatings and safety-engineered designs, have improved safety and usability, driving adoption. Increased use in chemotherapy, dialysis, and parenteral nutrition, along with the expanding geriatric population, further fuels demand for reliable vascular access solutions worldwide.

New Study Demonstrated up to 73% Reduction in Genome Analysis Errors Using AI-trained Models Versus Standard Approaches 

On 29 April 2026, Complete Genomics announced study findings demonstrating that artificial intelligence-trained variant calling models had reduced genome analysis errors by up to 73% when applied to DNBSEQ™ sequencing data generated on its high-throughput sequencing platform, compared to conventional industry-standard pipelines.

The study had emphasized the importance of accurate genome interpretation for applications such as early disease detection and targeted therapies, noting that traditional analytical methods often introduced errors that limited reliability and increased the need for further validation. By integrating high-quality sequencing with AI models specifically trained on DNBSEQ data, the company had achieved improved accuracy and consistency across the genome, including in complex and clinically significant regions.

The results had also shown that the platform was capable of detecting genetic variations more precisely, including challenging sequence alterations, with performance in these difficult regions approaching that of long-read sequencing technologies.

Overall, the findings highlighted the potential of combining advanced sequencing technologies with AI-driven analytics to deliver highly accurate and scalable genomic insights. This advancement had been expected to support broader adoption of genomics in healthcare and life sciences, particularly in research and clinical applications.

Additionally, the AI-based analysis framework, PanVariants, has been introduced as an open-source resource to encourage further innovation within the genomics community. Complete Genomics had also scheduled a webinar on April 30 to discuss how the integration of high-throughput sequencing and AI-powered variant calling was advancing genomic analysis.

“This is about making high-quality genomic analysis scalable and economically viable,” said Radoje Drmanac, Ph.D., Founder and Chief Scientific Officer of Complete Genomics. “By integrating AI directly with our PCR-free library prep and clonal-error-free sequencing platforms, we are enabling more accurate detection of genetic variation, including in regions that have traditionally been difficult to analyze.”

“Across multiple datasets generated from the T1+, T7, and T7+ platforms, we observed consistently high accuracy for SNVs and indels using DeepVariant models trained on DNBSEQ data. These results highlight the robustness of the approach for scalable variant calling,” said Andrew Carroll, Product Lead at Google Research.

According to DelveInsight’s ”Next Generation Sequencing Market Report,” the global next-generation sequencing market was valued at USD 9.28 billion in 2023, growing at a CAGR of 18.96% during the forecast period from 2024 to 2030, to reach USD 26.30 billion by 2030. The increase in demand for Next-Generation Sequencing is primarily attributed to the rising cases of infectious diseases, such as the sudden outbreak of COVID-19 and the escalating burden of cancer, worldwide. Moreover, the rising application of NGS technology in clinical diagnosis and scientific research, and advantages such as efficient turnaround results, high speed, and accuracy exhibited by the NGS technology, among others, are some of the factors that would contribute to the global Next-Generation Sequencing market growth in the forthcoming years.

Calidar Completed Enrollment in First-in-Human Study of 4D Mammography System 

On 28 April 2026, Calidar Inc. announced that it had completed patient enrollment in its first-in-human clinical study evaluating its 4D Mammography system. The study, conducted in collaboration with Baptist Health Hardin, had enrolled 61 patients and marked an important milestone in the development of a next-generation breast imaging platform.

The 4D Mammography system had been designed to enhance diagnostic precision by capturing molecular-level signals within breast tissue, a capability not available with conventional imaging technologies. Using X-ray diffraction, the system aimed to differentiate between healthy and cancerous tissue by analyzing structural and compositional characteristics rather than relying solely on tissue density or shape.

Following the completion of enrollment, Calidar and its clinical partners had moved forward with data analysis to assess the system’s effectiveness. Early indications had suggested up to a fourfold improvement in diagnostic precision compared to traditional 3D mammography, although full results were still under evaluation.

The clinical study began in August 2025, when the first patient was successfully imaged using the system. The completion of enrollment had represented a key step toward validating the technology’s potential to transform breast cancer detection.

The study had taken place at Baptist Health Hardin, where patients requiring further diagnostic evaluation were enrolled. Participants had undergone 4D mammography imaging under investigational use conditions, and results had not been used for clinical decision-making. The study aimed to compare the system’s performance with existing mammography technologies, with a peer-reviewed publication expected in the latter half of 2026.

Calidar had also initiated plans to raise Series A funding to support a larger, multi-site pivotal study across the United States. Upon completion of this study, the company had intended to submit its findings for regulatory approval. At the time, the 4D Mammography system had remained investigational and had not yet received clearance or approval from the U.S. Food and Drug Administration.

According to DelveInsight’s “Mammography Devices Market Report,” the global mammography devices market is expected to increase from USD 2,671.77 million in 2025 to USD 5,427.49 million by 2034, growing at a CAGR of 8.25% during the forecast period from 2026 to 2034. The market for mammography devices is primarily driven by the rising incidence of breast cancer, increasing awareness about early detection, and government-led screening programs. Technological advancements such as digital mammography, 3D tomosynthesis, and AI-assisted diagnostics, along with growing healthcare expenditure and aging female populations, further boost adoption. Favorable reimbursement policies and the expansion of private diagnostic centers also contribute to the market’s steady growth.