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CONNEQT Health files FDA package after $5.5M raise
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CONNEQT Health files FDA package after $5.5M raise

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  • CONNEQT Health has lodged an FDA pre-submission package for its SphygmoCor Cloud medical software.
  • The regulatory milestone follows a recently completed $5.5 million capital placement.
  • The submission drives a long-term commercial strategy to transition from hardware sales to software subscription.

CONNEQT Health (ASX:CQT) has lodged an FDA pre-submission package for its SphygmoCor Cloud medical software to seek US clearance.

This software format contrasts with the company's historical reliance on dedicated hardware installations across more than 40 countries.

The company stated that it anticipates written regulatory feedback in August before a formal financial year 2027 submission.

A recently completed $5.5 million placement and a proposed $0.5 million share purchase plan will provide near-term corporate funding.

Following the announcement, the CONNEQT Health share price was unchanged at $0.022.

Management intends for the cloud platform to eventually support subscription models, enterprise licensing, and direct-to-patient channels.

This move follows previous corporate updates targeting a business transition towards recurring, data-driven revenue streams.

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