PARIS – Diagnostic Medical Systems SA (DMS) is spinning off its medical imaging division into Asit Biotech NV. This agreement, between two firms listed on the Euronext exchange, involves French med-tech company DMS merging its flourishing medical imaging business with the Belgian biopharmaceutical firm and acquiring a controlling stake in the company.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
Ilex Medical Ltd. has injected $3.2 million into cell therapy company Kadimastem Ltd., as it prepares to list on the Nasdaq. As part of the investment, Ilex Medical was granted a total of 1,407,130 options (60% coverage) in two series, at exercise prices of $2.2 and $2.7 per share (up to 100% from the share price at the transaction). If exercised, it would increase the total investment to $6.7 million.
Lunit Inc. has raised $61 million in a fundraising round, getting it closer to its planned list on South Korea’s Kosdaq. “We will use these funds as working capital to research and develop artificial intelligence (AI) products, as well as developing our global market,” a Lunit spokesperson told BioWorld. Seoul, South Korea-based Lunit secured new investors for this round, including U.S. life science investors Healthquest Capital, Casdin Capital LLC, and The American Cancer Society’s Brightedge fund. Asia Pacific-based global health care investors included Tybourne Capital Management Ltd. and NSG Ventures Pte. Ltd.
LONDON – Cases of the new variant of SARS-CoV-2, which has an unprecedented number of mutations in the spike protein that is the target of most COVID-19 vaccines, have now been reported across Europe and in Canada, following its initial detection in South Africa.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, Lensgen, Novacyt, Qaigen.