Yearly Archives: 2020

FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System

The White House Guidelines for Opening Up America Again are providing us a roadmap for optimizing operations and new work arrangements, as well as the Centers for CDC guidance for protecting workplace exposures to COVID-19 in non-healthcare settings.

Infervision Receives FDA Clearance for the InferRead Lung CT.AI Product

InferRead Lung CT.AI product is currently in use at over 380 hospitals and imaging centers globally.

Encompass Health Purchases Land in St. Augustine, Florida

"This new, state-of-the-art hospital will help meet a growing need for intensive physical rehabilitative services in the St. Augustine area," said Linda Wilder, president of Encompass Health's southeast region.

MedAlliance Announces Enrollment of the 1st Patient In Its SELUTION SLR™ 014 DEB Study for the treatment of In-Stent Restenosis

The objectives of this prospective, randomized, single-blind multicenter study are to demonstrate the safety and efficacy o SELUTION SLR™ 014 DEB n the treatment of ISR with either drug-eluting or bare-metal stents. The study will support the submission for FDA approval.

FDA COVID-19 Update for July 9, 2020

Today, a U.S. District Court in Florida granted a motion for default judgment and a permanent injunction against the Genesis II Church of Health and Healing, Jonathan Grenon, and Jordan Grenon for violating federal law by distributing their product, "Miracle Mineral Solution