The FDA cleared Hyperfine Research Inc.’s advanced image reconstruction technology using deep learning for its portable magnetic resonance imaging device, Swoop. The bedside MRI unit’s artificial intelligence application received clearance in January and is used with deep learning to improve image quality and diagnostic value. Hyperfine and Liminal Sciences Inc., which share a founder in serial entrepreneur Jonathan Rothberg, are both combining with special purpose acquisition company Healthcor Catalio Acquisition Corp. to go public in a deal valued at $580 million. The companies reported on Nov. 29 that the Securities and Exchange Commission declared the registration statement on form S-4 for the combination to be effective and the SPAC’s shareholders will vote on the transaction on Dec. 21. Read More
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. Read More
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. Read More
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). Read More
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. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cardiovascular Systems, Eurofins, Ferrum Health, GE Healthcare, Hearing Assist, Imotion, Innerscope, Kheiron Medical, Merit Medical, Novarad, Optellum, Pen Rad, Piezo Motion, Therapixel. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, Lensgen, Novacyt, Qaigen. Read More
