Zimmer Biomet Received U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology
On November 14, 2025, Zimmer Biomet Holdings, Inc., a leading global medical technology company, announced that its enhanced ROSA® Knee with OptimiZe™ system received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This upgraded version of the ROSA® Knee System is designed to provide surgeons with a more tailored and streamlined experience, supporting greater accuracy and consistency in robotic-assisted total knee replacement procedures.
ROSA Knee with OptimiZe introduces advanced intelligent surgical planning, along with upgraded positioning, tracking, and alignment capabilities, to enhance precision and minimize variability across users. The platform also features a more intuitive user interface, allowing surgeons to access the specific data they need at any point during the procedure.
“More and more surgeons are integrating robotic technologies, because they empower surgeons to achieve better outcomes for patients3,” said Dr. Peter Sculco, hip and knee replacement surgeon at Hospital for Special Surgery in New York. “ROSA Knee with OptimiZe expands on existing benefits of ROSA Knee by giving surgeons new tools to reduce landmark variability to optimize implant placement and reproducibility. The enhancement also provides more options to maintain an individualized surgical approach to optimize patient outcomes and surgeon confidence.”
Designed for use with the industry-leading Persona® Knee System4, ROSA Knee with OptimiZe empowers surgeons who follow a functional alignment approach by offering customizable surgeon profiles. These profiles automatically generate surgical plans that position the implant and balance the knee according to each patient’s unique anatomy and the surgeon’s individual preferences. For surgeons who use kinematic alignment, the platform provides the industry’s only automated kinematic alignment capability, enabling precise resurfacing to restore the knee’s pre-arthritic position and native joint lines.
“As a leader in advancing innovation in orthopedic robotics, we are committed to improving and enhancing our robotic technologies to better meet the needs of surgeons and improve efficiency in the OR, with the ultimate goal of delivering better outcomes for patients,” said Shaun Braun, senior vice president and chief information and technology officer at Zimmer Biomet. “ROSA Knee with OptimiZe was designed in partnership with our seasoned team of ROSA surgeons to make robotic-assisted knee replacement surgery more personalized, accurate, and efficient for surgeons. With our proprietary algorithm, OptimiZe Planning™, surgeons can create customized profiles that generate personalized surgical plans, reducing planning time by an average of 46%.
ROSA Knee with OptimiZe introduces five major enhancements to the ROSA Knee System, each designed to elevate precision, consistency, and ease of use in total knee arthroplasty. The OptimiZe Planning™ feature creates a personalized surgical plan tailored to the surgeon’s knee-balancing preferences, while OptimiZe Landmarking™ offers an intuitive “painting” tool that minimizes variability in anatomical landmarking. OptimiZe Tracking™ incorporates motion-sensitive Active Track™ technology to enable collaborative resections without the need to pin the Cut Guide to the bone, ensuring accuracy even when the leg moves. Additionally, OptimiZe Kinematic Alignment™ delivers an automated alignment plan based on bony landmarks to help restore the knee to its natural, pre-arthritic position. Completing the suite, OptimiZe Experience™ provides a simplified, customizable interface that allows surgeons to tailor their workflow and display settings for each case.
As per DelveInsight’s “Surgical Robotic System Market Report,” The global surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by an aging population and a higher prevalence of lifestyle-related health issues, is further underscoring the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
IceCure’s ProSense® Cryoablation System Received Regulatory Approval in Switzerland for Indications Including Breast, Lung, Liver, and Kidney Cancer
On November 18, 2025, IceCure Medical Ltd., a developer of minimally invasive cryoablation technology that eliminates tumors by freezing them as an alternative to surgical removal, announced that its ProSense® system and cryoprobes have received official registration and approval for distribution from Swissmedic, the Swiss Agency for Therapeutic Products. The approval covers the treatment of malignant and benign tissues in the breast, lung, liver, kidney, and musculoskeletal (bone) system, including palliative applications. These approved indications align with those already granted for ProSense® in the European Union.
“We believe approval in Switzerland adds to the strong regulatory and commercial momentum we’ve generated leading up to and following the FDA’s recent marketing authorization for ProSense® in low-risk breast cancer,” said Eyal Shamir, IceCure’s Chief Executive Officer. “Gaining access to another important European market enhances our ability to scale adoption and brings us closer to making ProSense® a standard-of-care option to surgery for patients globally.”
About ProSense®
The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy in women aged 70 and older, including those who are not eligible for surgical treatment options. A complete overview of benefits and risks is available on the Company’s website.
ProSense® is a minimally invasive cryosurgical solution that destroys tumors by freezing them. The system utilizes liquid nitrogen to generate large lethal zones, enabling effective ablation of both benign and malignant lesions in organs such as the breast, kidney, lung, and liver.
By supporting faster recovery and minimizing pain, surgical risks, and complications, ProSense® provides significant value for both patients and healthcare providers. Its portable design and reliance on liquid nitrogen enable efficient, office-based procedures for breast tumors treatment, further enhancing accessibility and convenience.
As per DelveInsight’s “Cryoablation Devices Market Report,” The global cryoablation devices market is estimated to advance at a CAGR of 8.8% during the forecast period from 2024 to 2030. The demand for cryoablation devices is primarily being boosted by the rising number of patients suffering from cardiovascular disorders, the increase in the number of patients suffering from chronic disorders such as cancer, the higher availability of customized probes for cryoablation, the increasing technological advancements associated with the cryoablation devices will help in contributing in the overall market growth of the cryoablation devices during the forecast period from 2024 to 2030.
Clairity Raised $43 Million in Series B to Launch First FDA-Authorized AI Platform for Breast Cancer Risk Prediction
On November 13, 2025, Clairity, Inc., an AI-driven precision health company specializing in image-based risk prediction, announced the completion of a $43 million Series B funding round. The investment will support the commercialization of Clairity Breast, the first FDA-authorized artificial intelligence platform capable of predicting a woman’s five-year breast cancer risk directly from a routine mammogram. The funds will also advance the development of Clairity Breast 3D and Clairity Heart, the company’s upcoming solutions designed to assess cardiovascular risk using the same standard imaging exam.
The funding round was co-led by ACE Global Equity and Santé Ventures, with continued support from the Breast Cancer Research Foundation (BCRF) and participation from several new investors. This strong backing underscores widespread confidence in Clairity’s mission to transform the detection, management, and prevention of breast cancer, as well as the potential of its AI platform to expand into broader population health applications.
The newly secured capital will enable Clairity to accelerate U.S. commercialization efforts, strengthen collaborations with leading imaging centers and health systems, and advance the development of its comprehensive predictive health platform.
Building on the FDA authorization of Clairity Breast and its early deployment across major health systems, the company is now expanding its pipeline to include additional AI-driven predictive tools for other high-impact diseases, using the same deep learning foundation that powers Clairity Breast. The Series B investment will further support reimbursement initiatives and partnerships to ensure that Clairity Breast becomes widely accessible across community imaging centers nationwide.
For decades, we have relied on mammography to detect cancer only after it is visible,” said Connie Lehman, MD, PhD, Founder of Clairity. “With Clairity Breast, we can now use the same images to predict who may be at risk over the next five years, supporting earlier intervention, fewer late-stage diagnoses, and more lives saved. This is the future of breast cancer care: predictive, personalized, and preventive.”
“Our fundraising is about more than capital; it’s about momentum,” said Jeff Luber, Clairity’s President and CEO. “With FDA authorization in hand and commercial partnerships underway, Clairity Breast is poised to redefine how the world approaches breast cancer. We’re proud to stand at the forefront of a paradigm shift—from detection to prevention—and to deliver technology that empowers women and their doctors to predict risk to support action before cancer starts.”
“Clairity represents a rare combination of scientific rigor, regulatory validation, and transformative clinical impact,” said Gabriella Antici, Partner and Chief Investment Officer, ACE Global Equity. “Predictive imaging is the next frontier in oncology, and Clairity Breast is the first real-world embodiment of that promise.”
“BCRF has long believed that prevention is the ultimate cure,” said Donna McKay, President and CEO, Breast Cancer Research Foundation. “Clairity’s technology embodies that vision, turning existing imaging infrastructure into a proactive tool for risk stratification toward earlier interventions that can save lives. We’re proud to continue supporting their work as they bring this innovation to women everywhere.”
“Santé is proud to support Clairity in advancing a new era of predictive breast health,” said Kevin Lalande, Founding Managing Director and Chief Investment Officer of Santé Ventures. “By pairing clinically validated AI with scalable access channels, Clairity exemplifies the type of innovation that can help drive better outcomes for patients and greater cost efficiency across the healthcare system.”
According to DelveInsight’s “Breast Cancer Diagnostics Market Report,” 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 the Breast cancer diagnostics market during the forecast period from 2024-2030.
Distalmotion Raised $150 Million to Accelerate US Expansion of the DEXTER® Robotic Surgery System and Names Chas McKhann as Executive Chairman
On November 18, 2025, Distalmotion, a global MedTech company dedicated to expanding access to the advantages of robotic surgery across outpatient care settings, announced the successful completion of its Series G financing round. The company raised $150 million USD, led by Revival Healthcare Capital, with participation from existing investors.
The capital infusion will primarily support the accelerated U.S. commercial rollout of DEXTER, Distalmotion’s soft tissue robotic surgery system, and further advance ongoing clinical and product development programs. A key priority in the company’s U.S. growth strategy remains the Ambulatory Surgery Center (ASC) market, one of the fastest-expanding areas in surgical care, fueled by the continued shift toward efficient, outpatient surgical procedures.
“This funding marks another important milestone on our journey,” said Greg Roche, CEO of Distalmotion. “The continued commitment of our investors validates our vision to break down barriers to robotic access through simplified operations. As we enter our next phase of US market acceleration, ASCs represent a tremendous opportunity for DEXTER. The ongoing support from our investors reaffirms our roadmap, our mission, and the value DEXTER brings to minimally invasive surgery.”
“I am thrilled to join the Distalmotion team,” said Mr. McKhann. “Distalmotion has reimagined how robotic surgery can be adopted across care settings because DEXTER delivers all the benefits of robotic surgery – dexterity, precision, and ergonomics – while also offering flexibility, efficiency, and value. With the recent FDA clearance in gynecology and release of DEXTER product enhancements, the company is poised to accelerate adoption in the US and globally at this pivotal stage in its growth trajectory.”
As per DelveInsight’s “Surgical Robotic System Market Report,” The global surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by an aging population and a higher prevalence of lifestyle-related health issues, is further underscoring the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
Envoy Medical Achieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical Trial
On November 18, 2025, Envoy Medical® Inc., a hearing health company advancing fully implanted hearing technologies, announced that all 10 patients enrolled in the first stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have successfully completed their six-month follow-up evaluations. Importantly, no serious adverse events have been reported, underscoring the trial’s positive momentum and the device’s encouraging safety profile.
This milestone marks a significant step forward for the Acclaim implant and supports Envoy Medical’s planned timeline for ongoing trial progression, FDA submission, and future commercialization.
“This marks another important step forward on our mission to redefine hearing health with fully implanted technology solutions,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “All 10 patients from the initial cohort have now successfully completed their six-month follow-up visits with encouraging results, strengthening confidence among our clinical teams and investigators in the potential of this technology. Patients are eager for a solution that delivers discreet, full-time hearing without external wearable hardware, and the Acclaim fully implanted cochlear implant continues to show promise toward meeting that need in an impactful way.”
According to DelveInsight’s “Cochlear Implants Market Report,” The cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is experiencing substantial growth, primarily driven by the increasing prevalence of hearing loss & which incurs significant economic costs. Investing in cochlear implants & improving access to these devices, along with supportive reimbursement policies, are anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
Cardiovalve Submitted CE File for Approval Following Successful TARGET Study Completion
On November 17, 2025, Venus Medtech (Hangzhou) Inc. announced that Cardiovalve has submitted the CE technical file for its transcatheter tricuspid valve replacement (TTVR) system to DEKRA, the notified body overseeing CE mark approvals in Europe. This submission marks a significant milestone and follows the successful completion of the TARGET study, which enrolled 150 patients and demonstrated the Cardiovalve system’s safety and performance.
Interim results from the TARGET study titled “Safety and Performance of the Cardiovalve Replacement System for Tricuspid Regurgitation” were presented on November 16, 2025, by Prof. Georg Nickenig on behalf of the study investigators during the Top Late-Breaking Trials session at the PCR London Valves Main Arena.
The TARGET study evaluated 150 patients across 30 sites in Europe, the UK, and Canada as part of a prospective, single-arm, open-label, multicenter clinical trial designed to assess the safety and effectiveness of the Cardiovalve TR System. The interim findings showed that TTVR with the Cardiovalve system successfully eliminated tricuspid regurgitation (TR) in most patients, despite 73% entering the study with massive or torrential TR, highlighting the device’s strong clinical performance.
Beyond efficacy, the procedure demonstrated an acceptable safety profile, with notable symptom improvement observed within 30 days of treatment. Patients will continue to be monitored for up to five years, and comprehensive clinical and echocardiographic data, including mortality and heart failure hospitalization outcomes, from the full cohort of 150 patients, will be shared in forthcoming updates.
Prof George Nickenig said: “The results of the Cardiovalve study are highly encouraging, demonstrating strong efficacy in tricuspid regurgitation (TR) reduction and a favorable safety profile, particularly with the new device iteration. These findings represent an important step forward, offering hope that patients suffering from TR will soon have access to a novel and effective treatment option.”
“The submission of the CE file marks a pivotal milestone and brings Cardiovalve closer to delivering transformative therapy for patients suffering from severe mitral and tricuspid regurgitation,” said Amir Gross, CEO of Cardiovalve. “This achievement reflects the commitment of a focused team with a shared vision, a team that doesn’t just aim; it hits the target. Deep appreciation goes to the investigators, coordinators, clinical partners, and most importantly, the patients and their families for their trust.”
Lim Hou-Sen, CEO of Venus Medtech, stated: “These promising results mark a significant advancement for patients suffering from tricuspid regurgitation. With the CE submission under review, Cardiovalve is well-positioned to achieve certification and begin commercial rollout of the TR system by 2027.”
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.
