Intuitive Ventures, the investment arm of Intuitive Surgical Inc., closed a $150 million fundraising round for its second fund, which will focus on investments in startups in three areas: precision diagnostics and interventions, digital ecosystems and improving health care access and coordination. Intuitive Surgical’s first venture fund raised $100 million that has been used to support more than 10 early-stage companies.
Venture Capital firm Sofinnova Partners has launched Sofinnova.AI, an artificial intelligence (AI) platform that it hopes will transform its approach to life sciences investment. The platform harnesses billions of data points spanning scientific literature, emerging therapeutic fields, and technological breakthroughs, and connects them with the firm’s own proprietary knowledge accumulated over 50 years.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was accorded a mere 60 days for comment, but nonetheless drew support from a number of stakeholders, including Foundation Medicine of Cambridge, Mass.
The U.S. FDA’s advisory hearing on multi-cancer detection (MCD) tests suggests that the premarket requirements for these tests will be rigorous, if only because the agency stated at the outset of the hearing that it sees these tests as class III devices. However, the advisory committee also suggested that a registry be established to track outcomes for these tests, a requirement that is likely to prove expensive and time-consuming to fulfill.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABK Biomedical, Clordisys Solutions, Exactech, West Pharmaceutical.
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