FDA Panel Votes No On BD's Balloon For Below The Knee
Executive Summary
Shifting trial design and missing data, plus little evidence of benefit, worked against the paclitaxel-coated balloon, panelists and US FDA speakers said.
You may also be interested in...
US FDA Panel To Take Up Lutonix DCB Catheter For Lower-Leg Use Next Month
If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.
US High Court Punts On ‘Objective Falsity’ FCA Standard
Can a false-claims suit be filed if doctors have different opinions about whether a treatment was necessary? The Supreme Court won’t say.
Office Supply Vendor Faces Proposed Class Action Over Counterfeit N95 Masks
The proposed class action suit alleges that W.B. Mason took advantage of the pandemic by overcharging for the phony respirators.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Medtech Insight?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: