US clearance expands catheter brush market potential
This article was originally published in Clinica
Executive Summary
The US FDA has given FAS Medical the go-ahead to expand the use of its endoluminal brush from collecting biofilm samples from a central venous catheter (CVC) to removing obstructive material from the catheter's internal surface. The Sunbury on Thames, UK-based firm claims that the new 510(k) clearance will significantly increase the market potential for the product. It adds that, to its knowledge, the brush is the only product of its kind which has application in the two major post-insertion complications of CVCs - infection and occlusion.
You may also be interested in...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.