FDA Approves New Treatments and Medical Devices in March 2025 Roundup

FDA Roundup: Highlights from March 21, 2025

The U.S. Food and Drug Administration (FDA) has provided key updates on various health products and technologies as of March 21, 2025. In a significant development, the FDA has granted approval for Fabhalta (iptacopan), a new oral treatment intended for adults suffering from complement 3 glomerulopathy (C3G). This rare illness leads to kidney inflammation and damage, affecting the glomeruli which filter blood to produce urine. Patients will administer Fabhalta twice daily, and detailed dosing instructions can be found in the prescribing information provided by the FDA.

In addition to the drug approval, the FDA also released crucial updates regarding medical devices. Recently, the agency issued an early alert concerning the Calyxo CVAC Aspiration Systems, which includes revisions on updated usage instructions. This alert is part of the FDA's Center for Devices and Radiological Health (CDRH) communication pilot aimed at refining the recall process for medical devices. The initiative strives to enhance transparency and decrease the time it takes to inform the public and health professionals about potential risks associated with medical devices.

Furthermore, the FDA has authorized the market introduction of the CORIS System, a groundbreaking automated endoscope channel cleaner designed for use with the Olympus EVIS EXERA III CF-HQ190L colonovideoscope. This device presents an innovative approach to maintaining hygiene standards in colonoscopy procedures, which are vital for colon cancer screening. The CORIS System automates the cleaning process, effectively delivering a cleaning agent through the channels before they are rinsed and purged with air, although external surfaces still require manual cleaning per the manufacturer's guidelines.

These announcements reflect the FDA's ongoing commitment to safeguarding public health by ensuring the effectiveness and safety of medical treatments and devices. As an integral part of the U.S. Department of Health and Human Services, the FDA continues to protect citizens by regulating a wide spectrum of products, including drugs, vaccines, medical devices, and food safety.

The FDA's work not only focuses on product approval but also on enhancing the overall health regulatory framework, thereby assuring consumers of the safety and effectiveness of products they rely on. For further information on these updates or other related inquiries, please reach out to the FDA's Office of Media Affairs or consult their official newsroom for additional resources.

For continuous improvements and updates on health regulations and product approvals, staying informed about FDA communications is essential for healthcare providers, consumers, and industry stakeholders alike.