Intercontinental Robotic Telesurgery Treats First Patient In Clinical Trial
The groundbreaking, FDA-approved trial was undertaken by Dr. Vipul Patel, who performed a prostatectomy from Florida on the patient who was in Angola. In other news, a neurosurgical robot; Andembry approval; and more.
ABC News:
Exclusive Look At Groundbreaking Remote Robotic Surgery: Patient Was In Africa; Doctor Was In Florida
Fernando da Silva, who lives in the southern African nation of Angola, was diagnosed with prostate cancer in March. Three months later, he underwent a procedure to cut out the cancer from a surgeon who has done tens of thousands of similar procedures. But the doctor performing the surgery was 7,000 miles away -- in Orlando, Florida. Da Silva was the first patient of a groundbreaking human clinical trial approved by the U.S. Food and Drug Administration to test transcontinental robotic telesurgery. (Benadjaoud, Serratos, Mendelsohn, and Miller, 6/18)
Modern Healthcare:
Brain Navi Receives FDA Approval For NaoTrac Neurosurgical Robot
Taiwanese surgical robotics company Brain Navi Biotechnology said Tuesday the Food and Drug Administration approved its NaoTrac neurosurgical robot. It’s designed to assist with brain tumor biopsies, deep brain stimulation and other complex brain surgeries. (Dubinsky, 6/17)
MedPage Today:
FDA Approves Once-Monthly Hereditary Angioedema Drug
Anti-factor XIIa biologic garadacimab (Andembry) got the FDA greenlight for use in preventing hereditary angioedema (HAE) attacks in adult and pediatric patients ages 12 years and older, CSL announced. Garadacimab is the only HAE treatment to target factor XIIa, a plasma protein that plays a key role in the unpredictable and potentially life-threatening attacks of swelling that can affect the abdomen, larynx, face, and extremities. The monoclonal antibody is self-injected subcutaneously once monthly from initiation using an autoinjector that takes 15 seconds. (Phend, 6/17)
MedPage Today:
Clozapine's REMS Program Officially Over
The FDA has officially eliminated clozapine's risk evaluation and mitigation strategy (REMS) program, with all REMS operations stopped as of June 13.The announcement comes several months after a joint FDA advisory committee voted to eliminate the REMS program for clozapine that was put in place due to the risk for severe neutropenia associated with the drug, which is used to treat schizophrenia and schizoaffective disorder. (Monaco, 6/17)
KFF Health News:
KFF Health News’ ‘An Arm and a Leg’: The Prescription Drug Playbook, Part I
About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. So, this year, “An Arm and a Leg” asked listeners: What strategies have you used when you’ve been struck by pharmacy sticker shock? (Weissmann, 6/18)
