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.
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 Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a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.
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.
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.
At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the Centers for Medicare and Medicaid Services. The clearance of Claritypro to diagnose ESE follows receipt of an FDA breakthrough device designation in two different categories in the past year, setting the stage, Ceribell CEO Jane Chao told BioWorld, for expanded access to critical seizure diagnosis technology.
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.
Researchers at the Georgia Institute of Technology (Georgia Tech) in Atlanta have developed melting microneedle patches comprising a drug dissolved or dispersed in a wax.
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