FDA Roundup: April 9, 2024
The system includes the use of a motion scaling function, which scales down the surgeon's movements.
SILVER SPRING, Md., April 9, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Friday, the FDA authorized for marketing MMI North America, Inc.'s Symani Surgical System, indicated for use during certain microsurgical procedures on small blood vessels and lymphatic ducts in adults. The system includes the use of a motion scaling function, which scales down the surgeon's movements. Microsurgery covers procedures involving the use of microscopes and small instruments to perform small-scale surgical techniques. The system is intended for use by trained physicians in the operating environments described in the device's labeling.
- On Friday, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. View full prescribing information for Enhertu.
Additional Resources:
Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration
