FDA

FDA Approves Second Alzheimer’s Drug That Can Slow Disease

(WASHINGTON) — U.S. officials have approved another Alzheimer’s drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment. The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It’s only the second …

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FDA OKs the First Menthol E-Cigarettes

The Food and Drug Administration (FDA) on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, the government’s strongest indication yet that vaping flavors can reduce the harms of traditional tobacco smoking. The FDA said it authorized four menthol e-cigarettes from NJOY, the vaping brand recently acquired by tobacco giant Altria, which also makes …

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Advisory Panel of Experts Endorses F.D.A. Approval of New Alzheimer’s Drug

A committee of independent advisers to the Food and Drug Administration voted unanimously on Monday that the benefits outweigh the risks of the newest experimental drug for Alzheimer’s disease. Alzheimer’s afflicts more than six million Americans. It has no cure, and there is no treatment or lifestyle modification that can restore memory loss or reverse …

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FDA Reviews MDMA Therapy for PTSD, Citing Health Risks and Study Flaws

The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the …

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Hologic AI-powered cancer screening system wins FDA approval

Medical technology firm Hologic has been granted clearance from the FDA to market its Genius Digital Diagnostics System, powered by the company’s Genius Cervical AI algorithm. The digital cytology system–a medical diagnostic tool used to examine cells under a microscope to detect abnormalities or diseases–integrates deep learning-based AI with advanced volumetric imaging technology to aid …

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Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance

Surgical robotics and mixed reality company Zeta Surgical announced it secured FDA special 510(k) clearance for advanced functionalities and expanded compatibility of its cranial navigation system for neurosurgery. The mixed-reality navigation system offers surgeons real-time “GPS-like” guidance with millimeter precision. With a computer vision engine ensuring continuous accuracy despite patient movement, the company says the system …

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Experts Say Safer Eyedrops Will Require New FDA Powers

WASHINGTON — When you buy eyedrops at a U.S. store, you might assume you’re getting a product made in a clean, well-maintained factory that’s passed muster with health regulators. But repeated recalls involving over-the-counter drops are drawing new attention to just how little U.S. officials know about the conditions at some manufacturing plants on the …

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FDA Is Screening Cinnamon Imports for Lead: What to Know

The Food and Drug Administration (FDA) is investigating cinnamon apple puree and applesauce products amid reports of elevated blood lead levels in at least 34 individuals.  Residents in more than 20 states have reported illness after exposure to cinnamon apple products offered by three brands: WanaBana, Weis, and Schnucks. The goods are manufactured in Ecuador …

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Roundup: Nesa gets US FDA 510(k) for fibroid mapping tool and more briefs

Nesa obtains US FDA 510(k) for fibroid mapping tech Indian femtech Nesa Medtech has received the United States Food and Drug Administration 510(k) clearance for its fibroid mapping tool. Its Fibroid Mapping Reviewer Application assists in the diagnosis and planning of interventional procedures for patients with uterine fibroids. It generates a 3D model of the …

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Roundup: South Korean AI software for sepsis detection gets US FDA nod and more briefs

SpassMed scores US FDA 510(k) for AI sepsis detection software South Korean medical AI company SpassMed has received the United States Food and Drug Administration’s 510(k) clearance for its AI-powered sepsis detection software.  The AI solution called SpassageQ has been approved as software as a medical device for identifying sepsis, anaphylaxis, and hypovolemic shock.  South Korean …

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