Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.

Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach.

Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.

The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.

Lumos Diagnostics Inc.’s stock shot up 162% Wednesday morning on news that it signed a pivotal commercial deal with Phase Scientific International Ltd to expand its reach into the U.S. market for its Febridx rapid, point-of-care test for bacterial infections.

Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear Implant products portfolio and strategy told BioWorld.

Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted medical devices.

Lunit Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.

The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.

Tetratherix Ltd. raised AU$45 million (US$25 million) in its IPO on the Australian Securities Exchange (ASX:TTX) to support clinical development of its Tetramatrix polymer biomaterial platform to support bone regeneration, tissue spacing and tissue healing.