FDA bans Juul e-cigs after “insufficient” data on harmful chemicals

Following years of regulatory delays and court battles the US Food and Drug Administration (FDA) has finally called for all e-cigarette products from leading company Juul to be removed from sale in the United States. The FDA cited the primary reason fo… Continue reading FDA bans Juul e-cigs after “insufficient” data on harmful chemicals

Senators push for more frequent medical device cybersecurity guidance from FDA

Cybersecurity threats against health care have skyrocketed in recent years.

The post Senators push for more frequent medical device cybersecurity guidance from FDA appeared first on CyberScoop.

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First at-home test for flu, COVID and RSV authorized by the FDA

A new direct-to-consumer test designed to detect a number of different respiratory viruses, including COVID-19 and influenza, has been authorized by the US Food and Drug Administration (FDA). The test is the first of its kind to be approved by the FDA … Continue reading First at-home test for flu, COVID and RSV authorized by the FDA

FDA approves new kind of diabetes drug with anti-obesity potential

The U.S. Food and Drug Administration (FDA) has approved a new kind of treatment for type 2 diabetes. The once-weekly injection, called Mounjaro (tirzepatide), was found to be more effective at controlling blood sugar levels than other current treatmen… Continue reading FDA approves new kind of diabetes drug with anti-obesity potential

FDA clears new test for early detection of Alzheimer’s disease

A newly approved test uses levels of amyloid proteins in spinal fluid to determine the presence of toxic protein accumulations in the brain

The U.S. Food and Drug Administration (FDA) has approved a new test for Alzheimer’s disease. The test is the first in vitro diagnostic tool for Alzheimer’s to be approved for use in the United States measuring amyloid protein levels in spinal fluid.

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First COVID-19 breath test authorized for use in United States

The first breath-based COVID-19 test has been issued an emergency use authorization by the U.S. Food and Drug Administration (FDA). The device takes three minutes to return results and has been found to be over 90 percent accurate in detecting positive… Continue reading First COVID-19 breath test authorized for use in United States

FDA approves new Fitbit continuous heart rate monitoring algorithm

The U.S. Food and Drug Administration (FDA) has authorized a new Fitbit feature designed to continuously monitor a wearer’s heart rhythms for signs of atrial fibrillation. The roll-out is based on a massive study that last year reported the Fitbit algo… Continue reading FDA approves new Fitbit continuous heart rate monitoring algorithm

FDA pulls COVID antibody therapy as BA.2 variant becomes dominant in US

New modeling from the Centers for Disease Control and Prevention (CDC) estimates the BA.2 Omicron variant is now dominant in the United States. In related news, the Food and Drug Administration (FDA) has withdrawn its emergency use authorization for th… Continue reading FDA pulls COVID antibody therapy as BA.2 variant becomes dominant in US

Fourth COVID-19 mRNA vaccine dose approved for all older Americans

The U.S. Food and Drug Administration (FDA) has authorized a fourth mRNA vaccine dose for all individuals aged 50 and over. The authorization includes both Pfizer and Moderna vaccines and is recommended to be administered at least four months after a t… Continue reading Fourth COVID-19 mRNA vaccine dose approved for all older Americans