MedTech Dive

J&J submits FDA de novo request for Ottava robot in general surgery

Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft ...
Nasdaq

SS Innovations International, Inc. Plans FDA Submission for SSi Mantra 3 Surgical Robotic System in July 2025

SS Innovations plans to submit a De Novo request to the FDA for its SSi Mantra 3 surgical robotic system in July 2025. SS Innovations International, Inc. announced plans to submit a De Novo ...
ABC7

FDA updates risk classification for voluntary shredded cheese recall

The U.S. Food and Drug Administration has assigned a risk classification to a previous voluntary recall of various shredded cheese products sold at ALDI, Target, Walmart and other national retailers ...
ABC News

Canned green beans distributed by Target given 2nd-highest FDA recall classification

The FDA has assigned the recall a Class II designation. The U.S. Food and Drug Administration has assigned its second-highest classification to an earlier recall involving some canned green beans sold ...
Nasdaq

Spectral AI’s DeepView SnapShot® Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...

Johnson & Johnson Submits OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration

Johnson & Johnson today announced that the company has submitted the OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration (FDA) in an application for De Novo classification.