FDA delays EchoSolv HF 510(k) clearance for EchoIQ
FDA has not cleared the initial EchoSolv HF 510(k) application, prompting a review of regulatory options. EchoIQ says business momentum remains strong, supported by cash reserves and ongoing US commercial expansion.
FDA has not cleared the initial EchoSolv HF 510(k) application, and the company is reviewing its regulatory options. EchoIQ said business momentum remains strong, citing robust cash reserves and ongoing US commercial expansion. The company also said a webinar is scheduled to address investor questions.