Embattled Masimo Corp. disclosed it received a non-binding term sheet offering $850 million to $950 million for a potential joint venture that would include its consumer health products and the Sound United business. In an 8-K filing with the U.S. Securities and Exchange Commission, Masimo said it intends to negotiate for a higher price. Read More
Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency reissued a 2014 draft guidance that describes an enforcement policy about third-party communications about a drug or device. The draft appears to sidestep at least one major problem with the 2014 edition, but seems to suggest that manufacturers should consider addressing misinformation about an entire class of products. Read More
Smartcella Holding AB raised €50 million (US$54 million) in a new share issue that it will use to accelerate growth and ramp up commercialization of its endovascular Extroducer delivery device, in addition to strengthening its cell and mRNA operations. The funding is supported by existing and new investors including Astrazeneca, which committed to approximately half of the shares issued. Read More
South Korean researchers from Gwangju Institute of Science and Technology invented SPINDLE — a virtual reality-based robotic rehabilitation system — as a potential breakthrough therapy for tremor patients. Read More
Australia’s Therapeutic Goods Administration (TGA) made significant changes to some of its regulations, including those for software-based medical devices. The TGA said that entities that are switching their products to a higher risk classification can continue to offer them for six months after Nov. 1, 2024, if they have an application on file with the TGA, but only if the sponsor notified the agency of such intent prior to May 25, 2022. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Microbot Medical, Olink, Polynovo, Pulse Biosciences, Spectral AI, Tempus AI, Thermo Fisher. Read More
