Shares in Echo IQ Ltd (ASX: EIQ) jumped more than 10% after the company said it believed there was a "clear path" to getting regulatory approval in the US for its EchoSolv HF technology.
The Company's assessment has not identified concerns relating to the underlying technology or core functionality of the EchoSolv HF device, and Echo IQ remains confident that clearance remains achievable under the 510 route.
The company's shares were 10.7% higher at 57 cents on Thursday.
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Shares in Echo IQ Ltd (ASX: EIQ) jumped more than 10% after the company said it believed there was a "clear path" to getting regulatory approval in the US for its EchoSolv HF technology.
Echo IQ shares fell almost 50% last week when the company said that the US Food & Drug Administration had issued a Not Substantially Equivalent determination for the company's application for the approval of clinical use of EchoSolv HF.
The company said it "believes there is a path forward to getting FDA clearance for EchoSolv HF and it's progressing this as a priority''."
The Company's assessment has not identified concerns relating to the underlying technology or core functionality of the EchoSolv HF device, and Echo IQ remains confident that clearance remains achievable under the 510 route. Echo IQ has identified multiple potential pathways to progress EchoSolv HF towards FDA clearance, including an administrative appeal of the NSE determination, seeking review through the FDA Ombudsman, or submitting a new 510 application.
The company's shares were 10.7% higher at 57 cents on Thursday.
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