Freenome Holdings Inc. has landed $290 million from Basel, Switzerland-based Roche Holding AG to advance its multiomics platform for early cancer detection. The multimillion financing deal brings San Francisco-based Freenome’s total funding to more than $1.1 billion, securing its status as a unicorn company. It comes on the heels of a series D raise in December 2021, which netted Freenome $300 million from investors including Perceptive Advisors and RA Capital Management. Read More
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant. Read More
The existence of prior art isn’t always readily evident when companies in the device and diagnostic spaces file patent applications with the U.S. Patent and Trademark Office (PTO). As it turns out, literature describing that prior art need not be widely distributed to invalidate a patent as Quest Diagnostics Inc., of Secaucus, N.J., recently discovered, an object lesson for all in the med-tech space that research for prior art must be exhaustive if a patent is to hold up over time. Read More
A panel of leaders in women’s health at the 2022 edition of the J.P. Morgan Healthcare Conference addressed the challenges and benefits of digital health and new apps in enabling women to be the “chief medical officers” of their families’ health and to take the necessary steps to improve their own. The panel included moderator Lynne Chou O’Keefe, founder and managing partner of Define Ventures; Apple Inc.’s Vice President of Health Sumbul Ahmad Desai; Veronica Gillispie-Bell, assistant professor, Ochsner Health System; Found CEO Sarah Jones Simmer; Michelle Williams, dean of faculty at the Harvard T.H. Chan School of Public Health; and Tia Inc. CEO and co-founder Carolyn Witte. Read More
Two med-tech giants GE Healthcare Ltd. and Boston Scientific Corp. are teaming up to expand cardiac care in Southeast Asia. GE Healthcare and Boston Scientific reported plans to collaborate on an end-to-end cardiac care solution offered to cardiac care centers in Southeast Asia. The suite of care offered ranges from diagnostic to percutaneous coronary intervention. Read More
Clinicians at the University of Maryland have transplanted a heart from a genetically modified pig bred by Revivicor Inc., a subsidiary of United Therapeutics Corp., into a patient with end-stage heart failure. Read More
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agendia, Atara, Clario, Cloud DX, Ellume, Illumina, Imeka, Impeto, Seqster, Strata Skin, Xing Imaging, Withings. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cochlear, GI Supply, Indica Labs, Inivata, Lumiradx, Medtronic, Sight Diagnostics. Read More
