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FDA approves pivotal trial for FastWave Medical's peripheral IVL system
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Medtech
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United States
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Fusion42 · 13 August 2026 · Fusion42 review
The FDA has approved a pivotal trial for FastWave Medical's peripheral intravascular lithotripsy (IVL) system, marking a significant step toward potential regulatory clearance and market introduction of this medical technology in the United States.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You now have a clearer path to US market entry if you develop peripheral vascular devices. FastWave’s FDA trial approval reduces regulatory uncertainty and opens a window to compete or collaborate in this device category.
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1 source · 13 Aug 2026
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Medtechfda-approvalperipheral-ivlclinical-trialmedtechregulatory