Indianapolis-based pharmaceutical behemoth Eli Lilly has filed lawsuits against four compounders claiming that they sold unapproved products that contain tirzepatide, a key ingredient in the company's weight-loss and diabetes drugs, including top-seller Mounjaro.
The lawsuits against Mochi Health, Fella Health and Delilah, and Henry Meds were filed in the U.S. District Court Northern District of...
Digital therapeutic company Click Therapeutics was granted FDA marketing authorization for its prescription digital therapeutic for the preventive treatment of episodic migraines.
The de novo classification is for the company’s CT-132 offering, for which it received FDA Breakthrough Device Designation in 2022.
CT-132 is intended for the preventive treatment of episodic migraines in patients 18...
Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s Health Care Group.
Wolf, an FDA attorney, sat down with MobiHealthNews to discuss how staffing cuts at the Agency could lead to longer review times for medical device approvals...
A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed tests (LDTs) should be regulated as medical devices.
In a 450-page lawsuit filed by the American Clinical Laboratory Association (ACLA), molecular testing laboratory for infectious diseases...
Food and Drug Administration (FDA) staffers reviewing Elon Musk's Neuralink were among those fired as part of widespread layoffs within the Agency.
Musk is in charge of the new Department of Government Efficiency (DOGE), which is directing workforce cuts throughout numerous government agencies.
According to a Reuters report, the cuts affected 20 individuals within the FDA's Office of Neurological...
The Food and Drug Administration (FDA) published new draft guidelines aimed at improving the accuracy and performance of pulse oximeters by considering the range of skin tones.
The guidance, Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations, refers to pulse oximeters intended for medical purposes that are...
A South Korean manufacturer which claims to develop the world's first AI-powered doll companion for seniors has recently registered its product in the United States.
Hyodol has recently announced that its AI companion doll of the same name has been registered as a medical device with the US Food and Drug Administration.
WHAT IT'S ABOUT
Hyodol describes its doll, first released in 2019, as a...
The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing AI-enabled medical devices.
"This final guidance is part of the FDA's broader commitment to develop and apply innovative approaches to the regulation of device software functions and contains...
The Food and Drug Administration (FDA) has released its perspective on regulating AI in healthcare and biomedicine, stating that oversight needs to be coordinated across all regulated industries, international organizations and the U.S. government.
The Agency says it regulates industries that distribute their products to the global market, and therefore U.S. regulatory standards must be...
The FDA announced the Apple Watch atrial fibrillation (AFib) tool is qualified for use in clinical trials through its Medical Device Development Tools (MDDT) program, thus enabling researchers to use it to detect arrhythmias or abnormal heart beat.
Apple's tool is the first digital health tool to be qualified under the MDDT program, a voluntary program aimed at evaluating devices for use in...
