Outgoing CEO Kevin Sayer expects expanding coverage of Dexcom’s glucose sensors for people with Type 2 diabetes and ...

Dexcom is recalling certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because of a problem with the speaker that may cause it to fail to make an alert sound when blood sugar is dangero ...

A rtificial Intelligence is ground-breaking technology – expected to cut like a scythe through our ideas about work, leisure, ...

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...

The FDA claims the wearable tech company's BPI offering is "adulterated" and "misbranded," and is being sold without the ...

U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder ...

The U.S. Food and Drug Administration has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.

The letters instruct the companies to cease the illegal marketing of products containing added 7-OH or that have elevated levels of 7-OH.

FDA recalls Dexcom glucose monitors (G6, G7, ONE models) due to alert issues posing severe health risks. Read more here.

The letter also outlines FDA's vision for improvements to recall communications for these products, including short and long-term goals, all of which are framed as working to achieve the agency's ...

The FDA typically does not make complete response letters public, citing confidentiality, putting the onus on the drug companies to share that information, which they often do selectively.

FDA issues warning letters to distributors of food, dietary supplements and unapproved drugs that contain 7-hydroxymitragynine (7-OH) and advises consumers that these products pose significant dangers ...