The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.

This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.

The DBS trial will look at the use of neurostimulation in people with treatment-resistant depression, which affects about 2.8 million Americans each year. The implanted device may relieve depression symptoms by changing activity patterns in the brain.

Exact Sciences’ Cologuard at-home colorectal cancer screening test was the first of its kind when it was introduced to the US market in 2014. What’s ahead for the company as its flagship product moves into its second decade? Medical director Paul Limburg spoke to Medtech Insight about the potential of home cancer screening.

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

The devices include a digital therapeutic to treat ADHD and a tongue muscle stimulator to prevent sleep apnea and snoring. They all initially reached market via the de novo process and have now been declared class II.