Rutger Zietsma, founder of Manus Neurodynamica and one of In Vivo's Rising Leaders of 2022, explains how his prior work guided his journey into executorship, and the issues of trust and talent in a start-up environment. 

The makers of breathing machines said in comments to the US agency that it must address language in its draft Quality Management System Regulation that the companies say would place onerous traceability requirements on most medical devices.

The tens of thousands of Medical Device Reports sent to the US agency included 124 reports of death associated with Philips’ June 2021 recall of millions of BiPAPs, CPAPs, and other mechanical ventilator devices.

The US FDA is weighing whether to force the embattled company to repair, replace or refund recalled BiPAP, CPAP and other mechanical ventilator devices. Philips Respironics may attend an “informal hearing” before the agency decides.