Senseonics announced the long-awaited FDA approval of its Eversense E3 implantable CGM, featuring a sensor that lasts up to six months. The company is also developing a one-year version of Eversense and a transmitter-less version, but the stock market is disappointed with its sales projections.
Senseonics’ modest revenue projections for 2022 disappointed investors, even as the company is touting the long-awaited US Food and Drug Administration approval of its next-generation Eversense E3 implantable continuous glucose monitor (CGM).
The new premarket supplement labels Eversense E3 for up to 180 days of continuous use. It supplement to...
Create an account to read this article
Already a subscriber?
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.
