In Brief: Endosonics
This article was originally published in The Gray Sheet
Executive Summary
Endosonics: Gains FDA approval for its Oracle Megasonics family of combined percutaneous transluminal coronary angioplasty and ultrasound imaging catheters. Intended for use with Cordis' Duralyn high-pressure PTCA balloon, the Megasonics catheter line "demonstrates the strategic advantages of an all-electronic design compared with competitive mechanical approaches (ultrasound transducer on a spinning drive shaft) because it can both provide images of the lumen and artery wall as well as perform PTCA," Endosonics says. The catheter system will be marketed in the U.S., Canada and Europe through Cordis, which has a marketing and joint technology development deal with Endosonics...
You may also be interested in...
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.