Abbott Laboratories took the next step in its years-long collaboration with Bigfoot Biomedical Inc. with the announcement that it had signed a definitive agreement to acquire the connected insulin cap maker. Financial terms of the transaction, which is expected to close this month, were not disclosed. The companies began working together in 2017 and in 2020, Abbott led a $55.1 million series C financing round.

Pitango Healthtech raises $175M for new fund

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. “We’re launching this new fund to continue to back entrepreneurs and invest in companies that are revolutionizing the health care industry,” said Ittai Harel, managing partner at Pitango Healthtech.

FDA drops three draft guidances for 510(k)s, including a predicate best practices draft

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 pounded out 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 Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a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.

Painchek rolls out first AI-powered pain assessment solution in North America

People who can’t verbalize their pain often end up being under medicated, and Painchek Ltd. uses artificial intelligence 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 first regulatory-cleared medical device for assessing pain, the Painchek app uses cameras in smartphones and tablets to conduct a facial scan of the person, which is analyzed in real time using facial recognition software to detect the presence of facial micro-expressions that are indicative of pain.

Neurochase further develops its device for drug delivery into the brain

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. The device can be used for the treatment or diagnosis of neurological diseases but is particularly suited for use in delivering therapeutic agents to the CNS, either directly into the brain parenchyma using the method of convection enhanced delivery, or by infusion into the cerebrospinal fluid. CNS disorders that may be treated with therapeutic agents delivered through the device include neurodegenerative diseases, movement disorders, an enzyme deficient condition, a neuroinflammatory disease, CNS infection, an acquired neurological injury, epilepsy, cancer, subarachnoid hemorrhage, and cerebral vasospasm.

Also in the news:

Adheretech, Elucid, Imaging Endpoints, Zimmer Biomet, Ibex, Laborie Medical Technologies, Levee Medical, Biocardia, Biological Dynamics, Caldera Medical, Circular Genomics, Medialliance, Viseon, Vitestro, Lucid Diagnostics, Techsomed, Venturemed Group