“ Cataracts are the most common cause of vision loss globally, and in Germany alone, 10 million patients are affected by cataracts. Due to advancements in cataract surgery and increased awareness of its safety and benefits, my practice has seen a growing number of middle-aged patients seeking early treatment,” said Prof. Dr. Ramin Khoramnia, Director of the University Eye Clinic in Dresden. “Many of these patients are still working, very active, and want high-quality vision for both distance and intermediate tasks. With Clareon Vivity, I can provide my patients a presbyopia-correcting IOL, significantly reducing their need for glasses. “
“Clareon Vivity will broaden my presbyopia correction offering to more patients, including those with ocular comorbidities like glaucoma, age-related macular degeneration (AMD), or dry eyes. Clareon Vivity’s broad range of dioptres and cylinders will help me address mild, moderate and high refractive error patients with a PCIOL,1 ” said Dr. Mercè Guarro, CEO Instituto de Oftalmologia Médica y Quirúrgica OMIQ & Head of Ophthalmology Department at Hospital Granollers. “Clareon Vivity is an excellent lens option that improves vision with a visual disturbance profile of a monofocal IOL, giving my patients the freedom to engage in activities they love, both during the day and at night.”
Clareon was recognized as a pristine material with one of the lowest levels of haze and glistenings compared to leading competitor IOLs, representing a significant advancement for surgeons and patients. It offered sharp, crisp vision with a proprietary edge to reduce glare and posterior capsular opacification, while its STABLEFORCE® Haptics ensured excellent axial and rotational stability. Clareon Vivity utilized X-WAVE™ Technology, leveraging wavefront-shaping optics to create a continuously extended focal range. Compared to aspheric monofocals, it reduced spectacle dependence, improved intermediate and near vision, and maintained overall mesopic contrast sensitivity. Around 90% of Vivity patients reported high satisfaction and would choose the lens again, with over 9 in 10 recommending it to others. With Clareon Vivity and Clareon Vivity Toric receiving CE Mark approval, European surgeons gained access to a comprehensive range of Clareon IOLs, including Clareon Monofocal, Clareon Toric, Clareon PanOptix®, and Clareon PanOptix Toric. The lenses were compatible with the Clareon Monarch® IV manual delivery system and the AutonoMe® Automated Pre-Loaded Delivery System, ensuring smooth implantation.
As per DelveInsight’s “Intraocular Lens – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global intraocular lens market was valued at USD 3.85 billion in 2023, growing at a CAGR of 4.89% during the forecast period from 2024 to 2030 to reach USD 5.13 billion by 2030. The demand for intraocular lenses is witnessing a surge primarily due to the rising eye diseases prevalence, increasing initiatives by various governments across the globe in controlling and treating blindness, technological advancements in IOLs, and the increasing geriatric population who are more susceptible to ocular ailments which are expected to contribute in the growing product demand thereby boosting the growth of the of the intraocular lens market during the forecast period from 2024 to 2030.
MicroPort® MedBot™’s Toumai® SP Laparoscopic Surgical Robot Gained NMPA Market Approval in China
On March 20, 2025, MicroPort® MedBot™ announced that its Toumai® SP Laparoscopic Surgical Robot received market approval from the National Medical Products Administration (NMPA) in China.
This advanced surgical robot approved for clinical use in multiple departments, including urology, general surgery, and gynecology. The Toumai® SP featured a highly integrated single-port design, allowing a 2.5cm incision at the belly button through which three snake-shaped instruments and a snake-shaped endoscope could be inserted, making it particularly effective in complex surgical environments. Its compact size, high adjustability, and minimal space requirements made it ideal for operating rooms with limited space, enhancing surgical adaptability.
Key features of the Toumai® SP included multi-degree-of-freedom snake-shaped instruments and a 3D high-definition flexible electronic endoscope, providing a wide field of view and eliminating blind spots. The robot also incorporated crossed dual C-arm technology, enabling precise control of dual robotic arms through a single minimally invasive incision, reducing the need for patient repositioning and minimizing tissue damage. This approval marked the launch of MicroPort® MedBot™’s fifth surgical robot, further expanding its portfolio of innovative robotic solutions across various specialties.
As per DelveInsight’s “Surgical Robotic System – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as increasing geriatric population who form a big part of at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
Abbott Initiated an Intravascular Lithotripsy Clinical Trial Aimed at Improving Coronary Artery Disease Treatment
On March 24, 2025, Abbott announced that the U.S. Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System, allowing the company to evaluate its effectiveness in treating severe calcification in coronary arteries before stenting.
The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) clinical trial was set to enroll up to 335 participants across 47 sites in the U.S. Traditionally, physicians relied on techniques like cutting balloons and atherectomy to address calcified arterial blockages. Intravascular Lithotripsy (IVL) emerged as a novel treatment aimed at breaking down calcium within the artery wall, potentially enhancing vessel expansion and improving stent placement. Abbott’s Coronary IVL System employed high-energy sound pressure waves to treat these calcified blockages, providing a new method to improve patient outcomes in coronary interventions.
“For people living with coronary artery disease, severe calcification can make treatment more challenging, often limiting the effectiveness of standard interventions like angioplasty or stenting,” said Eric Secemsky, M.D., director of vascular intervention at the CardioVascular Institute, Beth Israel Deaconess Medical Center in Boston, MA and co-principal investigator for the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial. “The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial will evaluate a possible new treatment option to prepare the vessel prior to stenting and optimize stent placement.”
“Abbott is a leader in treating coronary artery disease, offering the best diagnostics and therapeutic options for calcium detection and treatment at every stage. Through our expansive portfolio of treatment offerings, we aim to make interventions safer and more effective for people who need them most,” said Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott’s vascular business. “Now, by working with physicians to evaluate Abbott’s Coronary IVL System, we are exploring the next generation of calcium modification technology, advancing our portfolio of treatments for coronary artery disease.”
Abbott’s investigational Coronary IVL (Intravascular Lithotripsy) technology builds on the company’s existing vascular portfolio, offering a solution to address the limitations of currently available IVL systems. Abbott’s current portfolio provides comprehensive treatment solutions for assessing coronary arteries and detecting calcium buildup, which helps physicians identify the arteries most in need of plaque modification. This advanced Coronary IVL technology aims to enhance the effectiveness of plaque modification by using lithotripsy to safely break down hardened calcium deposits in the arteries, improving the success of coronary interventions. Abbott’s technologies are designed to ensure complete vascular support, covering artery assessment, preparation, and treatment, ultimately improving patient outcomes in coronary artery disease management.
According to DelveInsight’s “Lithotripsy Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global lithotripsy devices market was valued at USD 1.39 billion in 2023, growing at a CAGR of 4.32% during the forecast period from 2024 to 2030 to reach USD 1.78 billion by 2030. The lithotripsy devices market is growing significantly due to the rising prevalence of urolithiasis, technological advancements in product development, increased risk of end-stage renal failure, and rising awareness for the procedure is expected to escalate the demand for lithotripsy devices during the forecast period from 2024 to 2030.
BD Announced Progress in Clinical Trial of GalaFLEX LITE™ Scaffold for Breast Implant Revision Surgery
On March 20, 2025, BD (Becton, Dickinson and Company), a global leader in medical technology, announced the treatment of the first patient in an Investigational Device Exemption (IDE) clinical trial designed to support BD’s pursuit of Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for using GalaFLEX LITE™ Scaffold to reduce capsular contracture (CC) recurrence during breast revision surgery.
The multi-center STANCE trial aimed to determine whether the GalaFLEX LITE™ Scaffold could reduce the risk of CC and malposition during breast revision surgery. This pivotal study further solidified BD’s leadership in biomaterial science, advancing innovation in tissue reconstruction. The STANCE Study is an ongoing, multi-center clinical trial designed to evaluate the safety and efficacy of the GalaFLEX LITE™ scaffold in breast implant revision surgery, specifically for reducing capsular contracture recurrence and malposition. The trial will enroll at least 250 patients across 40 investigative sites and compare the outcomes of those receiving the GalaFLEX LITE™ scaffold to those undergoing conventional revision surgery without a supportive matrix or acellular dermal matrix (ADM). BD is committed to scientific rigor and patient safety, aiming to enhance women’s healthcare through proactive FDA engagement in developing innovative products.
“This milestone marks a significant advancement in our efforts to achieve FDA Premarket Approval for our first breast indication for GalaFLEX LITE™ Scaffold and reinforces the company’s commitment to improving patient outcomes through innovative technologies that reduce surgical complications,” said Rian Seger, worldwide president of the BD Surgery business. “Our team has worked closely with the FDA to help address a critical medical complication arising from implant-based breast surgery, and the first patient treated brings us closer to delivering a much-needed solution.”
GalaFLEX LITE™ Scaffold was engineered to conform to the desired anatomical structure, providing immediate strength and stability during the wound healing period. It was made from P4HB, a fully absorbable, biologically-derived polymer that had been used for over 10 years in hernia repair and other plastic and reconstructive procedures to support soft tissue weakness or deficiency.
According to DelveInsight’s “Breast Reconstruction – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global breast reconstruction market was valued at USD 554.50 million in 2023, growing at a CAGR of 6.54% during the forecast period from 2024 to 2030 to reach USD 810.14 million by 2030. The breast reconstruction market is witnessing positive growth owing to various factors such as the increasing prevalence of breast cancer, the increase in the number of cosmetic & reconstructive surgeries, the surge in the launch of technologically advanced breast reconstruction products, and the factors such as aging, race, & ethnicity drives the breast reconstruction demand. Therefore, the market for breast reconstruction is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
GE HealthCare Unveiled the Invenia ABUS Premium, Leveraging AI to Speed Up Scanning and Support Early Cancer Detection in Dense Breasts
On March 20, 2025, GE HealthCare announced the launch of Invenia™ Automated Breast Ultrasound (ABUS) Premium, its latest 3D ultrasound system featuring advanced artificial intelligence (AI) and innovative technologies designed to deliver faster, reproducible supplemental screening and streamline exam readings for patients with dense breasts.
The ABUS Premium offers a non-invasive design that significantly enhances the patient experience. A patient experience study revealed that 100% of women would recommend an ABUS exam to their best friend. This advanced technology helps reduce unnecessary biopsies by providing specific image features that distinguish and detect malignant tumors, enabling clinicians to escalate care more quickly. Additionally, the ABUS Premium reduces patient exposure to radiation or contrast agents, as it does not use iodinated contrast or ionizing radiation. The new Reverse Curve™ transducer is designed to follow the natural contour of a woman’s breast anatomy, while adjustable compression levels ensure personalized comfort during the exam.
Increasing evidence supported ABUS as a valuable tool for detecting cancer in dense breasts by providing clearer, more detailed images and enhancing the sensitivity of detecting invasive cancer when combined with mammography.
“Women with dense breasts often face poorer outcomes due to malignancies detected at later, more advanced stages. Invenia ABUS Premium equipped with AI has the potential to optimize clinicians’ screening capabilities, enabling them to detect even small, early-stage cancers with a high degree of confidence in women with dense breasts,” said Karley Yoder, CEO of Comprehensive Care Ultrasound, GE HealthCare. “Invenia ABUS Premium is designed to help deliver the best possible outcomes for patients while also prioritizing the patient experience with features to improve scan speed and enhance comfort during an exam.”
GE HealthCare launched the Invenia ABUS Premium to manage high patient volumes along the breast care pathway while enhancing image quality and clinical confidence. The system introduced Verisound™ AI tools, including Scan Quality Assessment for immediate evaluation of breast coverage and positioning, and Auto Nipple Detection for consistent marker placement. The Fast Scan tool increased scan speed by up to 40%, while cSound™ Imageformer ensured high-resolution image quality. Physicians could quickly review exams remotely using the Invenia ABUS Viewer with AI Assistant, improving reading efficiency. The non-invasive design enhanced patient comfort, and 100% of women in a study recommended the exam. The technology reduced unnecessary biopsies and patient exposure to radiation or contrast agents. Invenia ABUS Premium received FDA Premarket Approval and was showcased at major events like the 2025 European Congress of Radiology (ECR).
According to DelveInsight’s “Breast Cancer Diagnostics – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global breast cancer diagnostics market was valued at USD 4.20 billion in 2023, growing at a CAGR of 6.67% during the forecast period from 2024 to 2030 to reach USD 6.16 billion by 2030. The breast cancer diagnostics market is witnessing a positive growth owing to the factors such as, increasing prevalence of breast cancer, increasing age and sedentary lifestyle, technological advancements, government initiatives to increase the rate of screening and diagnosis, thereby all factors contributing to the growth of Breast cancer diagnostics market during the forecast period from 2024-2030.
Okami Medical Expanded Its Portfolio with the Introduction of the SENDERO® MAX Delivery Catheter
On March 24, 2025, Okami Medical announced that it had obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the SENDERO® MAX Delivery Catheter, marking a significant expansion of its embolization portfolio, which included the previously approved SENDERO Microcatheter and LOBO® occluders. This addition offered physicians an end-to-end solution for effectively blocking blood flow in peripheral arterial vessels ranging from 1.5mm to 9.0mm.
The SENDERO catheters were specifically designed for compatibility with the LOBO occluders, featuring a hydrophilic coating, stainless steel braid, and radiopaque marker band to optimize trackability and ensure accurate device placement. The LOBO occluder’s unique design, leveraging proprietary HDBRAID® technology, formed a highly occlusive pore structure that helped to substantially reduce blood flow and speed up vessel closure.
“We are thrilled to expand our SENDERO catheter portfolio and offer another delivery tool to enable treatment with LOBO vascular occluders. Physicians can now use SENDERO across a wide range of LOBO sizes to treat patients quickly and effectively with a one-and-done solution,” said Rhonda Robb, President and CEO of Okami.
According to DelveInsight’s “Transcatheter Embolization and Occlusion Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global transcatheter embolization and occlusion devices market was valued at USD 3.71 billion in 2023, growing at a CAGR of 9.14% during the forecast period from 2024 to 2030, to reach USD 6.25 billion by 2030. The transcatheter embolization and occlusion devices market is growing significantly due to the increasing cases of chronic disorders such as cardiovascular diseases including heart attack, atrial fibrillation, and coronary artery disease; respiratory disorders like asthma, chronic obstructive pulmonary disease (COPD), rising product developmental activities by key players, among others are expected to drive the market for transcatheter embolization and occlusion devices during the forecast period from 2024 to 2030.
