This article was originally published in The Gray Sheet
Westford, Massachusetts firm begins clinical studies of its optical coherence tomography platform as an imaging tool in cardiac interventional procedures. A 510(k) for the LightLab ImageWire to study and detect cardiovascular plaques is currently pending. Although the firm is not conducting the studies to support the 510(k), it anticipates expanding the planned two-center, 25-patient trial following clearance...
You may also be interested in...
Dispatches from a world turned upside down include FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.
A Phase III trial testing the antibody-drug conjugate sacituzumab govitecan was stopped early for efficacy, boding well for the BLA pending at the US FDA.
Deal Snapshot: Six companies seek to collect convalescent plasma from COVID-19 survivors to quickly develop hyperimmune immunoglobulin therapy for serious complications of the virus.