“I’m thrilled about the launch of the Medtronic Smart MDI system with the InPen™ app and Simplera™ CGM. This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. “By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia.”
The Missed Dose alert feature aims to reduce the occurrence of glucose highs, enhancing overall diabetes management. By minimizing the uncertainty in insulin dosing, the Medtronic Smart MDI system addresses a critical unmet need for MDI users, who often face the challenge of managing complex decisions related to insulin administration daily.
As per DelveInsight’s “Blood Glucose Monitoring Systems Market Report,” the global blood glucose monitoring systems market was valued at USD 12.12 billion in 2023, growing at a CAGR of 7.72% during the forecast period from 2024 to 2030 to reach USD 18.89 billion by 2030. The blood glucose monitoring systems market is expanding rapidly due to the rising prevalence of lifestyle style disorders such as diabetes and impaired glucose tolerance, growing product launches and approvals by key players, and the rising preference for minimally invasive techniques that are expected to significantly drive the demand for blood glucose monitoring systems from 2024 to 2030.
Zimmer Biomet Received FDA Approval for Oxford® Cementless Partial Knee, the Only Cementless Partial Knee Replacement Implant in the United States
On November 25, 2024, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced the U.S. Food and Drug Administration (FDA) Premarket Approval Application (PMA) Supplement approval for the Oxford® Cementless Partial Knee. This approval followed safety and effectiveness data derived from an Investigational Device Exemption (IDE) study and non-clinical testing for cementless partial knee replacement (PKR). The Oxford Cementless Partial Knee provides surgeons with an option for improved fixation, enhanced long-term implant survival rates, and greater efficiency in the operating room compared to the Oxford Cemented Partial Knee procedure. With over 20 years of clinical experience and more than 300,000 procedures conducted across Canada, Europe, the Middle East, Africa, and Asia, the Oxford Cementless Partial Knee is now the only FDA-approved cementless partial knee implant available in the United States.
“Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency. The Oxford Cementless Partial Knee is coming into the U.S. with a proven track record of retaining more healthy anatomy with a less invasive approach and improved outcomes compared to a total knee replacement,” said Joe Urban, President, Knees at Zimmer Biomet. “We are excited to address the unmet U.S. demand for a cementless partial knee with a new offering which has 20 years of clinical experience in more than 50 countries.
“For younger and more active patients, the Oxford Cementless Partial Knee amplifies the benefits of a traditional partial knee replacement by offering knee flexion that resembles natural knee movement, and stronger adhesion of the implant to the bone for better long-term durability,” said Adolph V. Lombardi Jr., MD, FACS, President of JIS Orthopedics in New Albany, Ohio. “In my own practice, a cementless approach has increased OR efficiency by shortening my surgery time and reducing costs associated with cement preparation.”
Compared to traditional partial knee replacements that rely on bone cement to secure the implant, the cementless approach of the Oxford Cementless Partial Knee allows for natural bone growth to anchor the implant, offering better long-term fixation. The system features a mobile bearing that moves with the femoral component throughout the full range of motion, closely mimicking natural knee movement. This design enhances range of motion, provides a more natural feel, and ensures a more stable implant-to-bone fixation, contributing to improved long-term implant survival. Additionally, the tibial and femoral components are coated with titanium and hydroxyapatite to promote bone growth into the implant, further supporting durability and stability.
As per DelveInsight’s “Knee Reconstruction/Replacement Devices Market Report, the global knee reconstruction/replacement devices market was valued at USD 7.54 billion in 2023, growing at a CAGR of 4.52% during the forecast period from 2024 to 2030 to reach USD 9.78 billion by 2030. The knee reconstruction/replacement devices market is experiencing significant growth owing to the widespread instances of degenerative bone conditions like osteoarthritis and rheumatoid arthritis, the rise in product development & innovation activities, among others that are acting as key factors, thus contributing to the market growth of the knee reconstruction/replacement devices market during the forecast period from 2024 to 2030.
Perimeter B-Series OCT with ImgAssist AI 2.0 Demonstrated Super-Superiority Compared to Standard-of-Care in Pivotal Clinical Trial, Bolstering Capabilities in Optical Coherence Tomography (OCT) During Breast-Conserving Surgeries
On November 20, 2024, Perimeter Medical Imaging AI, Inc., a commercial-stage medical technology company, announced positive topline results from its pivotal study aimed at supporting the planned Premarket Approval Application (PMA) submission to the U.S. Food and Drug Administration (FDA) for its next-generation Perimeter B-Series OCT system. The system combined proprietary artificial intelligence (AI) technology with optical coherence tomography (OCT) for use in breast-conserving surgeries (BCS) in the United States.
The prospective, multicenter, randomized clinical trial involved 206 breast cancer patients undergoing BCS for Stage 0-III invasive ductal carcinoma and/or ductal carcinoma in situ. The study evaluated the effectiveness of the combined B-Series OCT imaging system with ImgAssist AI 2.0 compared to current standard lumpectomy methods, including palpation, specimen radiograph, intraoperative pathology, and ultrasound, in addressing positive margins. Participants were recruited from multiple clinical sites across the United States.
“These positive topline pivotal trial results are very encouraging for this patient population undergoing BCS,” said Dr. Sarah Butler, Perimeter’s Vice President, Clinical and Medical Affairs. “The trial easily met its primary endpoint, demonstrating that intraoperative margin assessment using OCT combined with Perimeter’s AI technology may be able to help lower re-excision rates by identifying regions of interest and guiding real-time decisions by surgeons on margin status in the OR. We are looking forward to submitting our FDA PMA for B-Series OCT with ImgAssist AI 2.0 in early 2025.”
“Surgeons have worked for years to innovate every step in the diagnosis and treatment plan for their cancer patients, with the ultimate goal of improving survivability and quality of life,” commented Adrian Mendes, Perimeter’s Chief Executive Officer. “The promise of B-Series OCT with ImgAssist AI 2.0 is greater peace of mind. Both for the surgeon who – no matter how skilled – currently faces nearly 1-in-5 odds of needing to perform repeat surgery due to positive margins; and for their patient, who under the current paradigm, typically has to wait (and worry) for up to seven days for their surgeon to receive a post-operative pathology report which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind. We believe that, based on these positive topline pivotal trial results, we are well-positioned to make a real difference in the treatment of cancer patients; and should the FDA approve the PMA, B-Series OCT with ImgAssist AI 2.0 has the potential for rapid acceptance and adoption by BCS surgeons in the United States.”
The B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more effectively address residual cancer at the surgical margin during breast-conserving surgery, outperforming current standard methods. The pivotal trial successfully met its primary endpoint, demonstrating a statistically significant reduction in the presence of residual cancer during surgery. These results indicate the super-superiority of the Perimeter B-Series OCT with ImgAssist AI 2.0 system, as evidenced by the lower bound of the confidence interval for treatment effect being greater than a predetermined minimal clinically meaningful difference. This enhanced capability helps surgeons achieve clear surgical margins, potentially reducing the need for reoperation.
According to DelveInsight’s “Optical Coherence Tomography 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 OCT devices market is moving towards positive market growth owing to factors such as the 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 OCT devices among others.
Edwards’ SAPIEN 3 Ultra RESILIA Valve Demonstrated Continued Excellent Outcomes for Patients in Real World Data
On November 25, 2024, Edwards Lifesciences, announced promising one-year data showcased the continued exceptional performance of its SAPIEN 3 Ultra RESILIA valve. An analysis of data from over 9,000 propensity-matched patients in the STS/ACC TVT Registry revealed that those who received the latest generation SAPIEN 3 Ultra RESILIA valve experienced superior one-year outcomes compared to recipients of the earlier generation SAPIEN 3 and SAPIEN 3 Ultra valves. The SAPIEN 3 Ultra RESILIA valve cohort demonstrated extremely low mortality rates, minimal re-intervention rates, larger effective orifice areas, lower echo-derived gradients across all valve sizes, and no paravalvular leaks in 84.4% of cases. Additionally, patients, with an average STS score of 3.6 and an average age of 77, reported significant quality of life improvements, including a clinically meaningful 31-point increase in KCCQ 2 score and an average one-day hospital stay, with 93% of patients being discharged to their homes.
“These strong, real-world data continue to demonstrate that patients treated with a SAPIEN valve experience excellent outcomes with rapid recovery and improved quality of life,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “These data add to the immense body of evidence with multiple years of follow up on the Edwards SAPIEN valve platform and more than 10 years of clinical experience with the RESILIA tissue.”
“This is the first large-population study that showed the latest generation SAPIEN 3 Ultra RESILIA valve results in improved 1-year survival after TAVR versus prior generation valves, given it reduces mild or greater paravalvular leak,” said Gilbert Tang, MD, MSc, MBA, Surgical and Academic Director of the Structural Heart Program for the Mount Sinai Health System and Professor and Vice-Chair of Innovation in Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai. “This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies.”
According to DelveInsight’s “Transcatheter Heart Valve Replacement Market Report”, the global transcatheter heart valve replacement market is estimated to grow at a CAGR of 13.75% during the forecast period from 2024 to 2030. The transcatheter heart valve replacement market is observing significant market growth primarily owing to the growing number of valvular heart diseases and aortic stenosis disorders across the globe. Further, the rising focus on minimally invasive surgeries, increasing technological advancements in device & surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, increasing burden of risk factors leading to valvular diseases, presence of a large number of devices in the pipeline, increasing product launches and approvals, surging investments by key players, among others will ultimately affect the demand for transcatheter heart valve during the forecast period from 2024 to 2030 growing at a substantial CAGR.
Abbott Launched AVEIR™ VR Leadless Pacemaker System in India to Treat Patients with Slow Heart Rhythms
On November 21, 2024, Abbott, a global healthcare leader, announced the launch of the AVEIR™ VR single-chamber ventricular leadless pacemaker for the treatment of patients in India with slow heart rhythms. The device was approved by the Central Drugs Standard Control Organization (CDSCO) in India and is also a U.S. Food and Drug Administration (FDA) approved product. This marks a significant advancement in patient care, offering new features to benefit both patients and their physicians.
Unlike traditional pacemakers, which require a chest incision, a generator pocket, and insulated cardiac leads to deliver electrical impulses to the heart, leadless pacemakers like the AVEIR™ VR eliminate the need for chest incisions, wires, and a generator pocket. Instead, the device is implanted directly into the heart’s right lower chamber (right ventricle) through a minimally invasive, catheter-based procedure via the groin, reducing the invasiveness of the procedure and enhancing patient recovery.
“A leadless pacemaker offers a powerful option for the treatment of people with cardiac arrhythmias or irregular heartbeats. Leadless pacemakers address known complications associated with traditional pacemakers,” said Dr. Balbir Singh, Chairman of Cardiology, Max Superspeciality Hospital. He further added, “Cardiovascular diseases like heart failure and cardiac arrhythmias form a major component of the chronic disease burden in India, and interventional therapies like pacemakers help improve patient outcomes.”
“The AVEIR VR leadless pacemaker was designed to make the implantation and retrieval processes as seamless as possible for physicians and provide improvements over existing options,” said Ajay Singh Chauhan, General Manager for Abbott’s Cardiac Rhythm Management business in India, Southeast Asia, HK, Taiwan & Korea. ” What sets this innovation apart is the impressive battery life and unique mapping capability and retrievability. Our goal is to continue to build on the introduction of AVEIR VR to provide more first-of-their-kind products in the future, revolutionizing how abnormal heart rhythms are treated.”
The AVEIR™ VR device features a unique mapping capability that enables physicians to measure electrical signals within the heart, allowing for optimal placement of the device prior to final implantation. This technology enhances precision and improves patient outcomes. Additionally, the AVEIR™ VR offers increased projected battery longevity compared to currently available leadless pacemakers, broadening its potential use for more patients. Furthermore, AVEIR™ is the only leadless pacemaker designed to be retrieved, providing flexibility if the device needs to be replaced or if therapy requirements change over time.
According to DelveInsight’s “Pacemakers Market Report”, the global pacemakers market was valued at USD 4.88 billion in 2023, growing at a CAGR of 5.85% during the forecast period from 2024 to 2030, to reach USD 6.84 billion by 2030. The demand for pacemakers is primarily motivated due to the rise in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and growing technological advancements, among others during the forecast period.
GE HealthCare Launched Pristina Via to Streamline Technologist Workflow and Improve Patient-Centered Breast Care, Innovating in Mammography
On November 26, 2024, GE HealthCare unveiled the new Pristina Via™ mammography system, designed to improve the screening experience for both technologists and patients. This innovative system equips mammography technologists with advanced tools that balance diagnostic accuracy with efficient workflows, enabling more patient-centered breast care. Building on the patient-focused Senographe Pristina platform, Pristina Via introduces enhanced features aimed at minimizing repetitive tasks and streamlining workflows, allowing technologists to concentrate on delivering high-quality, personalized care throughout the screening process.
The Pristina Via mammography system is equipped with advanced features designed to enhance workflow efficiency and improve patient care. One standout feature is its Zero-click acquisition functionality, enabling faster, seamless workflows with no wait time between exposures, allowing technologists to work at their own pace. Additionally, the Pristina Via DBT (Digital Breast Tomosynthesis) image-to-image cycle time is up to twice as fast as competing mammography systems, significantly improving efficiency. The system also supports vendor-neutral prior image comparison, which reduces the time spent analyzing previous exams and enables quicker final assessments.
“At GE HealthCare, we are dedicated to addressing our customers’ needs by delivering solutions that enhance the experience for both patients and healthcare professionals,” said Jyoti Gupta, PhD – President & CEO for Women’s Health and X-ray at GE HealthCare. “Pristina Via represents a significant evolution in our patient-focused Senographe Pristina platform which was designed by women for women. With the new in-room workflow, Pristina Via minimizes laborious tasks and provides technologists with the gift of time to prioritize what matters most: compassionate, patient-centered care.”
“Simplifying, automating, and streamlining the mammography exam to improve in-room workflows is critical to driving patient compliance and access to screening,” said Dr. John Simon, CEO of SimonMed, one of the largest nationwide outpatient imaging providers serving hundreds of thousands of women with breast cancer screening and diagnostic services annually. “As a leading mammography provider in the country, we are actively investing in new technologies, workflows, and AI innovation that improve clinical and operational outcomes. The enhancements offered by Pristina Via are part of our mission of making advanced technology accessible.”
The Pristina Via’s advanced capabilities help streamline technologists’ workflows while ensuring exceptional speed and efficiency. It also features a future-focused, scalable platform with full backward compatibility, providing imaging centers with access to the latest innovations while offering flexibility to accommodate evolving needs.
GE HealthCare developed the Pristina Via to further its commitment to innovation aimed at addressing the challenges faced by both patients and healthcare providers. The company conducted observations with mammography technologists, which highlighted that the primary challenge technologists face is maintaining the rapid pace of modern medicine while ensuring diagnostic accuracy and prioritizing patient-centered care. This valuable insight drove the creation of Pristina Via, which incorporates advanced features designed to streamline workflows, reduce repetitive tasks, and support technologists in delivering high-quality, personalized care without compromising on speed or precision.
According to DelveInsight’s “Mammography Devices Market Report”, the global mammography devices market was valued at USD 1.78 billion in 2023, growing at a CAGR of 9.15% during the forecast period from 2024 to 2030, to reach USD 3.65 billion by 2030. The demand for mammography devices is primarily witnessing growth on account of the increasing prevalence of breast cancer, technological advancements in breast imaging, and increasing focus on creating awareness regarding routine breast cancer screening programs.
