M. Jason Brooke, Attorney and Managing Member at Brooke & Associates, was kind enough to stop by our virtual fireplace to discuss the FDA’s latest draft guidances on 510k submissions and share tips on how medical device companies could best navigate them.

We're excited to announce that we've launched a clinical study with Daye, a UK-based gynaecological health startup, to develop a Diagnostic Tampon for at-home HPV and STI testing.

We're excited to announce that we've launched a fully remote clinical study with Oto, a UK-based digital health startup, to combat tinnitus.

The funding comes from Spotify-backer Creandum, with participation from PayPal co-founder Peter Thiel and returning investors firstminute, Seedcamp, Hambro Perks, Amino Collective, Page One Ventures and Calm/Storm. Additional investment has been provided by angel investors including Nadav Rosenberg, Kaysan Nikkhah, Trevor Martin, Soraya Darabi, Andrej Steinberg, Tom Krüger and Mithi Thaya.

To break the mold of the CRO status quo. To leverage social medial and technology to support research operations. The Lindus Health culture. Hear more from Anthony Brogno, Director of Clinical Operations, on why he joined Lindus Health.

The FDA recently released draft guidance on DCTs. Whilst this is a significant step towards providing a clear framework for implementing DCTs, some parts could be expanded on for the industry to take full advantage of their potential. We reflected on our learnings from delivering DCTs to highlight three key areas we think can benefit from additional detail: participant engagement, recruitment and retention, and the handling of investigational products.