Abbott Laboratories took the next step in its years-long collaboration with Bigfoot Biomedical Inc. with the announcement after the market close on September 6 that it signed a definitive agreement to acquire the connected insulin cap maker. The financial terms of the transaction, which is expected to close this month, were not disclosed. Read More
Israel’s venture capital firm Pitango has raised $175 million for a new fund focused on backing entrepreneurs leveraging data science, artificial intelligence (AI), medical devices and novel biology to transform health care. Pitango Healthtech II is the firm’s second fund dedicated to health care and will see investment go into 15 companies ranging from those at the seed stage to those wanting commercial stage investment.
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address some of those concerns. Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a manufacturer can recite in a 510(k) filing. Read More
People who can’t verbalize their pain often end up being under medicated, and Painchek Ltd. uses artificial intelligence (AI) to identify the presence of pain even when it may not be obvious. This gives a voice to those who cannot verbalize pain, while also driving objectivity and consistency in pain assessments. Read More
Neurochase Ltd. filed a patent for a septum-sealed transcutaneous, fluid-transferring device through which repeated access for the removal or delivery of fluid to the central nervous system (CNS) can be gained. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nanjing Changcheng Medical Equipment, Techsomed Medical Technologies, Venturemed Group. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atlantic Therapeutics, Biocardia, Biological Dynamics, Caldera Medical, Circular Genomics, Laborie Medical Technologies, Urotronic, Viseon, Vitestro. Read More
