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Echo IQ Begins Work to Address Issues Cited by FDA in EchoSolv HF Device Application

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Echo IQ (ASX:EIQ) began work to address the issues cited by the US Food and Drug Administration (FDA) in issuing its "not substantially equivalent" determination for an application for the firm's EchoSolv HF device, according to a Thursday Australian bourse filing.

The firm believes there is a clear path forward to obtaining FDA clearance for the device, which could be achieved over the coming quarters, per the filing. It considers the matters cited to be limited to aspects of statistical analysis supporting the clinical validation after a review of the regulator's feedback, and it did not identify concerns relating to the underlying technology or core functionality of the device.

It identified potential pathways to progress the device towards FDA clearance, including an administrative appeal of the determination, seeking review through the FDA Ombudsman, or submitting a new 510(k) application.

What else is happening in Asia?

Asia

Guangdong Skychem Technology Proposes Hong Kong Listing; Shares Up 4%

Guangdong Skychem Technology (SHA:688603) plans to list its H shares on the Hong Kong bourse to advance its globalization strategy and build an international capital operation platform.The proposal requires approvals from the board and shareholders as well as Chinese and Hong Kong regulators, according to a Wednesday filing with the Shanghai bourse.Shares of the electronic chemical manufacturer climbed 4% in recent trade.

Hang SengSHA:688603
Asia

Market Chatter: Anthropic to Open Office in Singapore in October

Artificial intelligence company Anthropic is set to open its office in Singapore in October, local media reports said on Wednesday, citing a company statement.This will be the company's fifth office in the Asia-Pacific region, with existing offices in Tokyo, Bengaluru, Seoul, and Sydney, the reports said.Anthropic has appointed Dale Finlay as general manager of ASEAN to lead regional commercial operations based out of Singapore.(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)

^STI
Asia

Range Intelligent Computing Technology to Commit 1 Billion Yuan to AI Fund

Range Intelligent Computing Technology (SHE:300442) will commit 1 billion yuan to an artificial intelligence fund, according to a Tuesday after-hours filing with the Shenzhen bourse.The amount is equivalent to 20.4081% of the 4.90-billion-yuan Xiamen Times Deep Venture Capital Fund Partnership, the filing said.The fund, which has a term of seven years, will invest in artificial intelligence, embodied AI, technology applications, and frontier technologies, the filing said.Shares in the digital infrastructure and data center operator rose 2% during the midday break on Wednesday.

SHE:300442