RESEARCH TRIANGLE PARK, N.C. — OCTOBER 23, 2025 – IQVIA MedTech, a trusted global partner delivering integrated regulatory, clinical and commercial solutions to medical device and diagnostic companies, today announced that MCRA, an IQVIA business, has successfully guided IceCure Medical through the regulatory pathway to secure U.S. Food and Drug Administration (FDA) marketing authorization for the first medical device indicated for local treatment of breast cancer.
IceCure’s ProSense® Cryoablation System (ProSense) is a minimally invasive device option to destroy tumors by freezing them with liquid nitrogen without surgical removal of breast tissue. Unlike traditional surgical approaches, such as lumpectomy, ProSense utilizes a needle-like cryoprobe placed under ultrasound guidance during an outpatient procedure that reduces surgical risks and recovery time.
“This partnership highlights our commitment to guiding clients through rigorous regulatory landscapes with expert insight and integrated solutions,” said Margeaux Rogers, Vice President of Regulatory Affairs at MCRA. “This achievement represents tremendous success not only for IceCure, but also for physicians and patients who are provided with an innovative new treatment option for breast cancer.”
The De Novo grant marks a major milestone in oncology innovation and regulatory achievement. MCRA led all FDA-related activities, including successful Breakthrough Designation submission, detailed and comprehensive De Novo submission, a successful Advisory Committee meeting, and discussions with FDA post-panel meeting, resulting in the final De Novo grant.
ProSense® was granted FDA marketing authorization for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors less than or equal to 1.5 cm in size and treated with adjuvant endocrine therapy. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.
“This FDA authorization is a defining moment for IceCure and for patients seeking innovative, less invasive breast cancer treatment options,” said Eyal Shamir, CEO of IceCure Medical. “MCRA was an exceptional partner throughout this complex regulatory journey. Their expertise, strategic guidance and integrated support were instrumental in helping us reach this milestone. Together, we have demonstrated what is possible when visionary companies and trusted partners unite to advance patient care.”
MCRA’s integrated service model — combining regulatory, clinical, data management and safety monitoring expertise — created a pathway to approval for IceCure’s device.
As part of IQVIA MedTech, MCRA reinforces and expands the organization’s MedTech capabilities by offering customers a powerful blend of legacy FDA expertise and integrated lifecycle solutions to accelerate first-of-its-kind device approvals in highly regulated therapeutic areas.
About IQVIA MedTech
IQVIA MedTech is a trusted global partner delivering integrated regulatory, clinical, quality and commercialization solutions to medical device and diagnostic companies. With former FDA and Notified Body reviewers, therapeutically aligned clinical teams and seasoned industry leaders, our team offers perspective on stakeholder expectations and clinical evidence strategies that align from the start. Bringing together regulatory insight, therapeutic specialization, industry expertise and high-quality health data and technology, IQVIA MedTech meets the demands of the evolving MedTech industry, on a global scale with local precision. This integrated approach empowers MedTech innovators to accelerate development, navigate complexity and optimize performance to deliver impactful technologies to patients. To learn more, visit: www.iqvia.com/solutions/industry-segments/medtech.
About IQVIA
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI®, advanced analytics, the latest technologies and extensive domain expertise. IQVIA is committed to using AI responsibly, with AI-powered capabilities built on best-in-class approaches to privacy, regulatory compliance and patient safety, and delivering AI to the high standards of trust, scalability and precision demanded by the industry. With approximately 90,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
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