Reach Surgical Announces CE Mark Certification for Innovative iREACH IRIS Stapling System; TOBY Earns FDA Breakthrough Tag for Innovative Urine-Based Cancer Detection Test; DuPont Introduces AmberChrom™ XT SL Resins to Streamline Biopharma Processing; Sectra Strengthens AI Roadmap with Completion of Oxipit Acquisition; KingstronBio Marks First Patient Implant of ProStyle M® in National Multicenter Study; MiRus Starts Recruiting Patients for STAR Trial Evaluating Siegel™ Valve

Reach Surgical Received CE Mark Approval for iREACH IRIS, First Powered Reusable Stapler with Real-Time Firing Curve™ and 90° Articulation

On 14 April 2026, Reach Surgical, the surgical solutions division of Genesis MedTech, received CE Mark approval for its next-generation powered stapling platform, iREACH IRIS. The system was designed to enhance surgical precision through Real-Time Firing Curve™ technology and up to 90° articulation, improving access and control in minimally invasive procedures.

The iREACH IRIS platform had provided continuous, location-specific force feedback along the staple line, allowing surgeons to better assess tissue compression and identify irregularities during firing. Unlike conventional staplers that offered only general feedback, this system delivered real-time visual and audible cues, improving intraoperative awareness and supporting more informed surgical decisions.

The device also featured Direction-True™ articulation, which translated the surgeon’s input directly into instrument movement even when the jaw was rotated. Combined with the Ultraflex™ 90 reload system, it achieved up to 90° articulation, exceeding the typical 45°–60° range of standard powered staplers. This enhanced maneuverability had been particularly valuable in complex procedures such as low anterior resection and single-port thoracic surgery.

Additionally, Curved Tip Technology and progressive staple height options have further improved tissue handling across general, colorectal, thoracic, and bariatric surgeries. The platform’s design also separated reusable and disposable components, with single-patient-use patient-contact parts to reduce contamination risk and streamline surgical workflows.

Overall, iREACH IRIS has represented a significant advancement in powered stapling technology by combining real-time tissue insight, enhanced articulation, and workflow efficiency to support more consistent surgical outcomes.

“At Genesis MedTech, we focus on translating clinical needs into practical solutions”, said Mr. Warren Wang, Chairman and CEO. “iREACH IRIS reflects this approach by moving beyond conventional stapling to providing surgeons with clearer, real-time insights into tissue behaviour during the procedure”.

As per DelveInsight’s “Surgical Stapling Devices Market Report,” the surgical stapling devices market was valued at USD 3.80 billion in 2023, growing at a CAGR of 8.36% during the forecast period from 2024 to 2030, to reach USD 6.15 billion by 2030. The surgical stapling devices market is experiencing significant growth due to the rising number of trauma cases resulting from road traffic accidents, the rising number of sports-related injuries, and the growing number of obese people who need bariatric surgery, which are acting as major factors contributing to the overall growth of the surgical stapling devices market during the forecast period from 2024 to 2030.

TOBY Received FDA Breakthrough Device Designation for its Urine-Based Multi-Cancer Early Detection (MCED) Test 

On 14 April 2026, TOBY, Inc., a biotechnology company focused on developing non-invasive cancer screening technologies, announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation to its urine-based Multi-Cancer Early Detection (MCED) test.

The designation had recognized the test’s potential to enable earlier detection of multiple cancers through a simple, non-invasive urine sample, addressing a significant unmet need in cancer screening. The MCED platform had analyzed volatile organic compounds (VOCs) present in urine using spectroscopy combined with machine learning algorithms to identify cancer-associated molecular signatures.

The test required only a single urine sample, positioning it as a scalable alternative to blood-based screening methods and supporting the potential for population-level cancer screening programs. It had been designed to detect multiple cancer types from one sample, covering a large proportion of global cancer incidence.

The MCED platform had become the first urine-based multi-cancer detection technology to receive FDA Breakthrough Device Designation. This regulatory status, which is intended to accelerate the development and review of innovative devices addressing serious or life-threatening conditions, had also previously been granted to TOBY’s urine-based bladder cancer test.

The designation had supported TOBY’s ongoing efforts to advance clinical studies, regulatory submissions, and future reimbursement discussions, while the company continued working closely with the FDA to generate the evidence required for broader clinical adoption.

“This Breakthrough Device Designation marks a defining moment for TOBY and for the future of cancer screening,” said Matthew Laskowski, Chief Executive Officer of TOBY. “It reinforces our conviction that urine-based, non-invasive detection can fundamentally change how and when cancer is identified, not just by improving the patient experience, but by enabling screening to happen earlier and at scale. We believe the next generation of cancer detection will be built around approaches that are simple, accessible, and designed for broad population use, rather than constrained by the limitations of existing modalities, and our platform is engineered with that vision in mind, supporting multi-cancer detection from a single sample. Working closely with the FDA, we are now positioned to accelerate clinical validation and generate the evidence required to bring a more scalable, widely accessible approach to early cancer detection into routine care.”

As per DelveInsight’s “Cancer Diagnostics Market Report,” the global cancer diagnostics market was valued at USD 125.13 billion in 2023, growing at a CAGR of 9.43% during the forecast period from 2024 to 2030, to reach USD 214.88 billion by 2030. The increase in demand for cancer Diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus on developing advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, among others, are anticipated to drive the global cancer diagnostics market during the forthcoming years.

DuPont Launched DuPont™ AmberChrom™ XT SL Chromatography Resins to Simplify Biopharmaceutical Workflows

On 14 April 2026, DuPont announced the launch of its AmberChrom™ XT20 SL and XT30 SL chromatography resins, expanding its bioprocessing portfolio to support more efficient purification of oligonucleotide and peptide therapeutics.

The company had developed these therapeutics as part of a growing class of targeted medicines used to treat genetic disorders, rare diseases, metabolic conditions such as diabetes and obesity, and certain cancers. These therapies required highly specialized purification processes to ensure purity, consistency, and scalability during clinical and commercial manufacturing.

The newly introduced AmberChrom™ XT SL resins had been designed as slurried versions of DuPont’s existing XT resin platform, allowing manufacturers to bypass the resin hydration step before column packing. This has helped reduce preparation time, lower equipment requirements, and streamline downstream workflows, which are often capital- and resource-intensive.

Among the new products, AmberChrom™ XT20 SL had offered the smallest particle size in the XT resin portfolio, enabling high-resolution separations for demanding applications. Meanwhile, AmberChrom™ XT30 SL has provided an alternative optimized for higher flow rates, offering flexibility across purification and polishing steps.

These resins had complemented DuPont’s broader chromatography portfolio, including AmberChrom™ CG resins for capture applications and AmberChrom™ TQ1, an anion exchange resin used for high-throughput oligonucleotide and peptide purification. Overall, the launch had strengthened DuPont’s position in advanced bioprocessing solutions supporting next-generation therapeutic manufacturing.

“As oligonucleotide and peptide therapies continue to gain momentum, manufacturers are under increasing pressure to improve efficiency without compromising performance,” said Shane Kendra, Global Bioprocessing Market Leader for DuPont Water Solutions. “With the introduction of DuPont™ AmberChrom™ XT20 SL and XT30 SL resins, we are helping customers simplify downstream processing by removing time-and capital-intensive preparation steps while maintaining the purity and yield required for bioprocessing applications.”

As per DelveInsight’s “Biopharmaceuticals Contract Manufacturing Market Report,” The Biopharmaceutical CMO market is estimated to advance at a CAGR of 7.38% during the forecast period from 2025 to 2030. This rise in chronic conditions, such as cancer, diabetes, and other autoimmune diseases, is driving the demand for innovative treatments and therapies, particularly biopharmaceuticals, which offer targeted and effective solutions, thereby escalating the market. 

In the dynamic pharmaceutical industry, biopharma contract manufacturing is essential for driving innovation and expediting the development of life-changing therapies. It offers seamless access to specialized expertise and state-of-the-art facilities, critical for high-quality and compliant clinical trials. Efficient procurement and management of raw materials by contract manufacturers ensures a streamlined supply chain, allowing pharmaceutical companies to concentrate on core R&D efforts and accelerate the development of groundbreaking therapies. 

This collaboration reduces time-to-market, enhances product quality, and ensures regulatory compliance, advancing healthcare outcomes and patient well-being. Contract Research Organizations (CROs) further support this ecosystem by providing specialized R&D services, including clinical trials, regulatory consulting, and data management. By partnering with CROs, pharmaceutical companies can focus on core research while ensuring regulatory compliance, streamlining drug development, and accelerating the delivery of innovative therapies to patients worldwide during the forecast period from 2025 to 2030.

Sectra Completed Oxipit Acquisition, Accelerating Autonomous AI in Radiology

On 15 April 2026, Sectra, an international medical imaging IT and cybersecurity company, completed the acquisition of Oxipit, a pioneer in autonomous artificial intelligence for radiology and developer of the first CE Class IIb certified solution for autonomous chest X-ray analysis.

The acquisition had strengthened Sectra’s position in the advanced AI-driven diagnostic imaging market by adding clinically validated autonomous AI capabilities to its portfolio of regulatory-approved solutions.

Following the acquisition, Sectra had taken ownership of Oxipit’s flagship product, ChestLink, which had been recognized as one of the most clinically validated autonomous AI systems in radiology. Unlike conventional AI tools that primarily assist radiologists by flagging findings or prioritizing cases, ChestLink has been designed to independently perform a defined diagnostic task.

The system had automatically identified high-confidence normal chest X-rays and removed them from the radiologist’s worklist, thereby allowing radiologists to focus on more complex or potentially abnormal cases. This workflow automation has improved efficiency and reduced diagnostic burden in high-volume imaging environments.

ChestLink had also held CE Class IIb certification, reflecting stringent regulatory and safety requirements for autonomous diagnostic AI systems in Europe. With this acquisition, Sectra had planned to further develop and integrate ChestLink into its broader imaging ecosystem, reinforcing its role in advancing autonomous AI adoption in clinical radiology workflows.

According to DelveInsight’s “Artificial Intelligence in Medical Imaging Market Report”, the global artificial intelligence in medical imaging market is expected to increase from USD 1,673.03 million in 2024 to USD 13,181.93 million by 2032, growing at a CAGR of 29.48% during the forecast period from 2025 to 2032. 

The global artificial intelligence in medical imaging market is being driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which increase demand for accurate and efficient diagnostics. Government initiatives and funding are promoting healthcare digitization and AI adoption, while key players are investing in product development and strategic collaborations to enhance imaging solutions. Rapid advancements in deep learning, machine learning, and computer vision are further improving diagnostic accuracy, workflow efficiency, and predictive capabilities, collectively accelerating market growth across regions.

First Implant of KingstronBio’s ProStyle M® Transcatheter Mitral Valve System Successfully Completed in National Multicenter Confirmatory Study 

On 09 April 2026, KingstronBio Technology (Changshu) Co., Ltd. announced that the first implantation of the ProStyle M® Transcatheter Mitral Valve System had been completed on March 12, 2026, under pure ultrasound guidance as part of its confirmatory clinical study. The procedure was carried out by Wang Chunsheng and Wei Lai at Zhongshan Hospital Affiliated to Fudan University, marking the official initiation of the national multicenter confirmatory clinical trial for the ProStyle M® system.

Before this milestone, the device had undergone a two-year First-in-Man (FIM) study involving 10 patients with an average age of 71 years. The results had demonstrated strong anchoring performance, with no cases of regurgitation reported. Ongoing clinical studies were expected to further validate the safety and effectiveness of the device.

KingstronBio Technology (Changshu) Co., Ltd. has been actively focusing on innovation in the heart valve segment, developing several proprietary technologies such as Micro-Ex™ anti-calcification treatment and AirBo™ dry storage technology to enhance the durability and biocompatibility of heart valves. The company’s broader portfolio included artificial bioprosthetic valves, annuloplasty rings, cardiac patches, and transcatheter valve systems.

The ProStyle M® system had been designed to address key challenges in transcatheter mitral valve replacement, including complex anatomy and risks such as left ventricular outflow tract obstruction. Its eccentric structural design enabled improved anchoring, reduced procedural complexity, and enhanced hemodynamic performance, offering a promising treatment option for patients with moderate to severe mitral regurgitation.

According to DelveInsight’s ”Transcatheter Mitral Valve Repair Devices Market Report,” the transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.

MiRus Begins Patient Enrollment in the STAR Randomized Trial of the Siegel™ Transcatheter Aortic Valve 

On 08 April 2026, MiRus announced that it had successfully enrolled and treated the first patients in the STAR Trial, a prospective, multicenter, randomized controlled study evaluating the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The initial procedures were performed at Piedmont Heart Institute by Pradeep K. Yadav and Vinod H. Thourani.

The STAR Trial (Siegel Transcatheter Aortic Valve Replacement Trial) had been designed to assess the safety and effectiveness of the Siegel™ THV in patients suffering from severe, symptomatic aortic stenosis, including those at low, intermediate, and high surgical risk.

The Siegel™ valve incorporated a low-profile delivery system and demonstrated strong hemodynamic performance, enabled by the use of proprietary nickel-free Rhenium alloys developed by MiRus. These materials provided high strength, fatigue resistance, and minimal recoil, supporting improved device performance during transcatheter implantation procedures.

“The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis,” said Pradeep K. Yadav, MD, National Co-Principal Investigator STAR Trial, “As TAVR has becomes standard of care across risk profiles, it is vital that we study the next generation of devices and techniques to minimize risks such as stroke, bleeding, pacemaker dependency and optimize valve longevity – especially in younger, lower-risk patients.”

“Our initial experience is very positive,” commented Pradeep K. Yadav, MD. “Siegel is much less invasive than current devices and can be placed very precisely due to the lack of foreshortening. This should lead to lower pacemaker rates. The hemodynamics are excellent due to the radial strength and porcine pericardial leaflets.”

According to DelveInsight’s “Transcatheter Heart Valve Replacement Devices Market Report,”  the transcatheter heart valve replacement devices market is estimated to grow at a CAGR of 13.75% during the forecast period from 2024 to 2030. The transcatheter heart valve replacement devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter heart valve replacement market during the forecast period from 2024 to 2030.