Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cutera, Enable Injections, Femasys, J&J.
Medline Inc. returned to the public markets with a blockbuster IPO of $6.26 billion, reportedly this year’s largest IPO globally. The upsized offering of more than 216 million shares at $29 per share will allow the medical supply giant to devote the entirety of the proceeds from its initially proposed 179 million shares toward repayment of debt.
Acryl Inc. debuted on South Korea’s Kosdaq Dec. 16, raising ₩42.12 billion ($28.5 million) in an IPO. Shares (KOSDAQ:0007C0) closed at ₩67,000 on the first day, up 243.5% from its offering price, before closing 30% down on Dec. 17 at ₩47,500. Seoul, South Korea-based Acryl sold 2.16 million shares priced at ₩19,500 each. Notably, Acryl won South Korea Ministry of Food and Drug Safety approval of Acryl-D01 software in December 2024, making it the country’s first AI-based digital therapeutic solution for depression screening and diagnosis. The generative AI-based medical software is cleared to analyze patient interviews and medical records and provide a probability score for clinical depression.
The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.
Siemens Healthineers AG became the latest company to sign a licensing agreement with Alzpath Inc. to use its pTau217 antibody in the development of a blood-based diagnostic assay for Alzheimer's disease. Alzpath previously signed deals with the likes of Roche AG and Beckman Coulter Diagnostics Inc. to use its pTau217 antibody to create diagnostic tests based for early detection and monitoring of Alzheimer's.
Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help to explain some of those spending increases.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Cellution Biologics, Cerapedics, Co-Diagnostics, Personalis.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baird Medical, Beyond Air, Biocerta Precision, Dacadoo, Femselect, GE Healthcare, Insightec, Lifeward, Neuropace, Population Health Partners, Shanghai Kohope, SOLVD, Spinol Medical Verita Neuro, Vaso Corp., Vaso Diagnostics, Vasohealthcare, Verita Healthcare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celltivity, Clarius Mobile Health, CMR Surgial, Hyperfine, Medibeacon, Numares, Pathmaker Neurosystems, Rivanna Medical, Sleepres.
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