Ekos Corp. may have found a fast, but kinder and gentler way to lyse obstructive blood clots, with a patented catheter that can simultaneously deliver ultrasound waves and a thrombolytic drug directly to the site of a clot.
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The company cited lackluster efficacy in its decision to discontinue development of V590 and V591. It will instead develop two drugs to treat COVID-19.
The regulatory tools are for use in medical device development.
The US agency plans to hold a virtual workshop that will use breakout sessions to get stakeholder feedback on specific hurdles preventing more pediatric devices coming to market.