From: itnonline.com Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for Clairity Breast, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025 – propelling a new era …
FDA Clears ZEISS INTRABEAM 700 for Intraoperative Radiation Therapy in Neuro-Oncology & Breast Cancer
By: Jax DiEugenio From: onclive.com Key Takeaways The ZEISS INTRABEAM 700 platform enhances intraoperative radiation therapy with robotic-assisted precision and digital-first design, improving procedural efficiency and connectivity. Key features include the ZEISS INTRABEAM SMART Stand, sterile SMART Spherical Applicators, and Radiance treatment planning software for preoperative simulation. RFID-equipped applicators and a Spherical Sizer Set streamline intraoperative radiation delivery, enhancing procedural …
HyperVIEW X-Ray System Receives FDA Breakthrough Device Designation for Breast Cancer Imaging
By: Kyle Doherty From: onclive.com Key Takeaways HyperVIEW X-ray system uses K-Edge subtraction and laser-Compton X-rays for enhanced breast cancer imaging, offering 100-times higher resolution and improved safety. Simulations suggest HyperVIEW may improve tumor detection by over 3000% compared to traditional contrast-enhanced mammography systems. Despite the benefits of contrast-enhanced mammography, its clinical adoption is limited due to high-level clinician requirements …
FDA Accepts BLA for Pertuzumab Biosimilar in HER2+ Breast Cancer
By: Chris Ryan From: onclive.com Key Takeaways HLX11, a pertuzumab biosimilar, is under FDA review for HER2-positive breast cancer treatment, supported by phase 1 and phase 3 trial data. Phase 1 trial confirmed pharmacokinetic equivalence and similar safety profiles between HLX11 and pertuzumab, with no impact from anti-drug antibodies. Phase 3 trial showed HLX11’s efficacy in achieving comparable pathological complete …
FDA approves Datroway for HR-positive, HER2-negative breast cancer
By: Lori Solomon From: medicalxpress.com The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The Trop-2-directed antibody and topoisomerase inhibitor conjugate is approved for patients who have had disease progression with prior endocrine-based therapy and chemotherapy for unresectable or …
FDA Expands Enhertu Approval to HER2-Ultralow Breast Cancer
By: Charles Bankheadmetastatic From: medpagetoday.com The FDA expanded the approval of trastuzumab deruxtecan (T-DXd, Enhertu) to include treatment of unresectable/metastatic hormone receptor (HR)-positive, HER2-low/ultralow breast cancer. Approval stipulates use in patients with disease that has progressed on or proven unresponsive to at least one prior endocrine therapy in the metastatic setting, according to a statementopens in a new tab or …
FDA Grants Breakthrough Device Designation to DCISionRT for Breast Cancer With DCIS
By: Ashling Wahner From: onclive.com The FDA has granted a breakthrough device designation to the DCISionRT test for patients with breast cancer with ductal carcinoma in situ (DCIS), according to an announcement from PreludeDX.1 DCISionRT assesses individual recurrence risk after breast-conserving surgery alone and with the addition of radiotherapy in women diagnosed with breast cancer with DCIS—also described as stage …
FDA Fast Tracks Emiltatug Ledadotin in Advanced/Metastatic Breast Cancer
By: Jordyn Sava From: targetedonc.com The FDA has granted a new fast track designation to emiltatug ledadotin for the treatment of advanced or metastatic breast cancer, specifically targeting patients with HER2-low or HER2-negative disease, including TNBC.1 This designation applies to patients who have previously received a topoisomerase-1 inhibitor antibody-drug conjugate (ADC). Additionally, hormone-receptor positive patients must have either received prior …
IceCure’s cryoablation system for breast cancer treatment gains FDA panel support
From: medicaldevice-network.com Based on the latest recommendation, the company anticipates receiving marketing authorisation for the system in the first quarter of 2025. IceCure Medical has received a favourable recommendation for its ‘ProSense’ Cryoablation System from the Medical Device Advisory Committee Panel of the US Food and Drug Administration (FDA). Leveraging liquid nitrogen to target benign and malignant lesions, the ProSense …
Women Will Be Notified Of Breast Density After a Mammogram: What to Know
From: healthline.com The FDA will now require all mammography reports to include whether a person has breast density. Breast density is considered a risk factor for breast cancer and can make it difficult to detect signs of cancer. Dietary and lifestyle modifications may help reduce breast density, but more importantly, they help lower a person’s risk of developing breast cancer. …