Getinge’s recall of its Vaporizer Sevoflurane Maquet Filling was recently identified as FDA class I after the company relayed ...

Teleflex and its subsidiary Arrow International recently received FDA Class I designation for its recall of the Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) catheter kits after reporting ...

This case study explains how Fresenius Medical Care launched the world’s largest global database of dialysis care with fully ...

The Chicago, IL-based company is the latest firm that blossomed during the early days of the pandemic to either fold or file for bankruptcy.

Through a federal lawsuit unsealed last week, Roche has accused manufacturers and sellers in India of selling counterfeit versions of its diabetes medical devices, specifically its Accu-Chek devices, ...

Uncontrolled accumulation of reactive oxygen species (ROS) and sustained inflammation make diabetic wounds difficult to treat ...

Zimmer Biomet recently announced a limited distribution agreement with Think Surgical in relation to its wireless handheld ...

Abbott is taking two of its continuous glucose monitoring (CGM) technologies over the counter. The Abbott Park, IL-based ...

For maintenance teams at manufacturing plants where healthcare devices, supplements, and medications are made, 21 CFR compliance is a daily consideration. Also, audits are a necessary but unpleasant ...

I’ve said this before, but it bears repeating: Medical device companies are not perfect, nor should anyone expect them to be. But manufacturers in this industry especially do have a responsibility to ...