Fda.gov

What is Digital Health

Digital tools are giving providers a more holistic view of patient health through access to data and giving patients more control over their health. Digital health … See more

Actived: 8 days ago

URL: https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health

FDA Approves First Treatment to Reduce Risk of Serious …

WEBThe 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 …

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Women's Health FDA

WEBSilver Spring, MD 20993. [email protected]. (301) 796-9440 Phone. (301) 847-8601 fax. Office of Women's Health. Content current as of: FDA has resources to help …

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FDA Approves First Treatment for Patients with Liver …

WEBThe 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 …

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Think It Through: Managing the Benefits and Risks of …

WEBTo obtain the benefits of riding in a car, you think through the risks. You consider the condition of your car and the road, for instance, before deciding to make that trip to the …

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FDA approves a new antibacterial drug to treat a serious …

WEBThe FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur …

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Augmented Reality and Virtual Reality in Medical Devices …

WEBAugmented Reality and Virtual Reality (AR/VR) have the potential to transform health care, delivering altogether new types of treatments and diagnostics, …

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CDRH Issues 2024 Safety and Innovation Reports FDA

WEBApril 17, 2024. The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH) Today, CDRH is issuing …

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Helping Patients Understand Their Prescription Information

WEBFDA proposed a new type of Medication Guide known as Patient Medication Information (PMI). PMI is designed to provide concise, easy-to-understand information …

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CDER Launches a Center for Clinical Trial Innovation FDA

WEBCDER is establishing the CDER Center for Clinical Trial Innovation (C3TI). C3TI will foster CDER’s innovation efforts and act as a central point for coordinating, …

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Aspirin for Reducing Your Risk of Heart Attack and Stroke

WEBFACT: Aspirin is a drug. If you are at risk for heart attack or stroke your doctor may prescribe aspirin to increase blood flow to the heart and brain. But any drug …

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Counterfeit Version of Botox Found in Multiple States FDA

WEBLinkedin. [4-16-2024] FDA is alerting health care professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in multiple …

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What does FDA do

WEBFDA is responsible for protecting the public health by regulating human and veterinary drugs, vaccines and other biological products, medical devices, our …

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Benefits and Risks FDA

WEBBenefits. An MRI scanner can be used to take images of any part of the body (e.g., head, joints, abdomen, legs, etc.), in any imaging direction. MRI provides better soft tissue …

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Outbreak Investigation of Salmonella: Organic Basil (April 2024)

WEBThe FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Salmonella infections linked to Infinite …

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Health Effects of Tobacco Use FDA

WEBEspañol. Tobacco use has serious effects on the health of users. In fact, tobacco use remains the leading preventable cause of disease and death in the United States, 1 …

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Food Safety in Your Kitchen FDA

WEBTry these recipes and follow the food safety tips along the way for a healthy and tasty meal at home! Recipe: Grilled Tuna with Chickpea and Spinach Salad. Atun a la parrilla con …

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FDA Warns Consumers to Avoid Certain Male Enhancement and …

WEBFDA is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a …

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January 2021 510(K) Clearances FDA

WEBCadde,SE DECISION MADE: 05-JAN-21 Istanbul TR 34490 510 (k) STATEMENT DEVICE: Sparrow Therapy System Spark Biomedical, Inc. 510 (k) NO: …

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Celebrating Women’s Health and Women’s History FDA

WEBOWH protects and promotes the health of women through policy, science, education, and outreach. This women’s history month, we’re reflecting on and celebrating 30 years of …

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HeartMate II and HeartMate 3 LVAS Recalled due to an Obstruction

WEBDevice UDI-ID Firm Reference Number; HeartMate II Sealed Outflow Graft with Bend Relief: 00813024010807: 103393: HeartMate II LVAS Implant Kit: …

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OTP Town Hall: CMC Readiness for Gene Therapy BLAs

WEBThe FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, June 4, …

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Colonna Brothers, Inc. Issues a Voluntary Recall for “1.5oz Marcum

WEBColonna Brothers of North Bergen, NJ is recalling its 1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon because of a possible health …

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Ossos-Sans contains hidden drug ingredients FDA

WEBThe Food and Drug Administration is advising consumers not to purchase or use Ossos-Sans, a product promoted and sold for pain on various websites, including …

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Global Mix, Inc Recalls Tejocote Products Because of Possible …

WEBThe recalled products are labeled as tejocote root but are toxic yellow oleander. Ingestion of yellow oleander can cause neurologic, gastrointestinal, and …

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FDA Drug Topics: Fraudulent Drugs: You’re Using What

WEBFDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present our FDA Drug Topic series of educational …

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U.S. Food and Drug Administration

WEBControl # Recd Date From Subject 2021-1 01/04/2021 FDA NEWS Copies of Form 483s issued by the CDER Office from November 1-30: 2021-2 Laura Cotoros-Petrulian, …

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