The Venus Versa Pro combines the applicator of the Venus Viva MD with the Venus Versa system which are both approved in Australia and registered in Australian Register of Therapeutic Goods (ARTG).
This milestone gives healthcare professionals an important tool for managing bacteremia by providing antibiotic susceptibility test (AST) results with unprecedented speed.
Benefits of the system, according to a news release, include maneuverability and visualization.
The clearance ends a three-year back-and-forth with the FDA to get the product to market.
Using neuromodulation technology, HeadaTerm 2 releases targeted electrical impulses to increase pain tolerance of its users. It is FDA-cleared for the preventative treatment of migraine headaches.
NanoDrop is the First Over-the-Counter Blood-Lancing Device Labeled for the Upper Arm to be Cleared in the United States, Changing the Landscape of the At-Home Consumer Testing Market and Decentralized Clinical Trials
TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery
Developed with Mayo Clinic, Eko Health’s Low Ejection Fraction (Low EF) AI gives healthcare professionals a powerful tool to more accurately assess possible heart failure in at-risk patients during a standard physical exam
Ross Bjella, Kelyniam’s CEO, said, “This approval will further boost Kelyniam’s sales momentum which started in Q4 last year
The FDA’s Investigational Device Exemption (IDE) clears the way for a pivotal study of Fractyl’s Revita system designed to maintain weight loss after patients have stopped taking GLP-1 drugs