The continuing proliferation of U.S. state privacy law drew the attention of developers of med-tech wearables for some time, but a recent Senate hearing delivered the news to Congress that a failure to preempt it will slow digital health innovation to a crawl.

The U.S. FDA recently posted three alerts under the agency’s early alert program, including an alert for the V6 and V8 versions of the Sigma Spectrum infusion pumps by Baxter International Inc., which was the result of a mix-up in software installation.

Serac Imaging Systems Ltd. reported encouraging data from two clinical trials demonstrating the effectiveness of its Seracam portable hybrid gamma-optical camera as a point-of-care imaging solution. The studies show the camera’s value in nuclear medicine, particularly for small organ imaging and image-guided surgery, while also revealing new potential applications beyond those initially expected.

Companies in the life sciences must tread carefully when it comes to the Anti-Kickback Statute, but a recent advisory opinion by the Office of Inspector General lends little clarity on the point.

Plasmacure B.V. secured €6 million (US$7 million) in series A funding for its Plasoma cold plasma system to treat complex wounds. The round was led by Venture Medical LLC, a U.S.-based provider of solutions for wound care, which also committed to spend over $10 million to support regulatory approval, reimbursement and U.S. market expansion of the Plasoma technology.