Brooklyn Park medtech FastWave wins FDA trial green light
FastWave, a Brooklyn Park medtech founded in 2021, has won FDA clearance to begin a pivotal clinical trial of its peripheral intravascular lithotripsy system.[1]
The company is launching a $40 million Series B to fund a pivotal trial of up to 125 patients.[1] FastWave aims to file a 510(k) with FDA by late 2027 and could launch commercially in early 2028.[1]
Founded in 2021 and based in Brooklyn Park, FastWave has raised $52 million and operates two manufacturing lines inside Switchback Medical's Brooklyn Park facility.[1] It is now the only remaining U.S. intravascular lithotripsy startup at the pivotal-trial stage after Johnson & Johnson's $13 billion Shockwave acquisition and several other major medtech deals.[1]
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📌 Key Facts
- FastWave, founded in 2021 and based in Brooklyn Park, has received FDA approval to begin a pivotal clinical trial of its peripheral IVL system.
- The company is launching a $40 million Series B round to fund a trial of up to 125 patients, aiming to submit a 510(k) to FDA by late 2027 and potentially launch commercially in early 2028.
- FastWave has raised $52 million to date, operates two manufacturing lines in Switchback Medical’s Brooklyn Park facility, and is now the only remaining U.S. IVL startup at the pivotal-trial stage after Johnson & Johnson’s $13B Shockwave acquisition and other major M&A deals.
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