Speaker issues are causing the devices to stop communicating with the user's CGM. Dozens of patient injuries have been reported, and the company is prepping a software update.

The therapy previously earned the FDA’s Breakthrough Device Designation due to its potential to treat certain cancers.

The agency recently issued a frequently asked questions fact sheet about the WISeR model days after House Democrats expressed concern about the initiative. 

Four men in Michigan have been charged and are accused of $1 million in fraud, in addition to the illegal distribution of controlled substances. The defendants include two physicians, a clinic manager and a patient recruiter.

New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.

The Medical Group Management Association shares concerns about the draft fee schedule published in July. A major concern is the government possibly changing how RVUs are set, rather than allowing the medical specialty representatives to have a say.

The FDA has received multiple reports of the devices, which are designed to be malleable, failing to retain their shape. The issue has been linked to three patient injuries so far, and customers are asked to return unused devices to the manufacturer. 

The Amsterdam-based manufacturer is looking to bolster its facility in Reedsville, Pennsylvania, which produces AI-enabled ultrasound systems