Applied Medical Technology (AMT) has received 510(k) clearance from the U.S. Food and Drug Administration for a new feeding tube. Cleveland area AMT’s “Low-Profile Transgastric-Jejunal Feeding Tube Kit” was listed among the FDA’s 510(k) clearances for October. Company official Dr. George Picha didn’t return a call seeking comment. The jejunum, which is referenced in the […]
Feeding tube manufacturer Applied Medical Technology has received a warning letter from the U.S. Food and Drug Administration for manufacturing and design issues at its suburban Cleveland location. The FDA cited seven specific violations it found in an April inspection of the medical device company’s Brecksville, Ohio, manufacturing facility. Warning letters are considered by the […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.