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The US FDA approved ReCor’s Paradise ultrasound renal denervation system, making it the first RDN system to reach the US market. Medtronic hopes its Symplicity Spyral radiofrequency RDN system will be the second RDN system on the US market, but it may face a more difficult path through the approval process.
Private Company Edition: ReCode’s series B venture capital round grew for a third time, now totaling $260m for precision genetic medicines. Also, DalCor closed an $80m series D, manufacturer Nephron amassed $350m, Hyku launched with a $56m seed financing and Magnet emerged with $50m.
The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.
FDA’s circulatory system advisory panel narrowly voted against Medtronic’s Symplicity Spyral, because one of the pivotal trials of the radiofrequency renal denervation system missed its primary endpoint and the patient population evaluated in the trial does not match the requested indication.
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