The FDA designated class II special controls classifications for two diagnostics and force separation catheters. 

Despite a March recall and a following update, Tandem’s t:slim X2 application is still causing the battery-depleting defect.

Avenda’s chief operating officer Brit Berry-Pusey spoke to Medtech Insight about the company’s CPT III code for its prostate cancer mapping AI and how regulatory bodies can align to support innovators.

This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.

 DHAC’s members, which span across multiple disciplines in the digital health industry, will hold their inaugural meeting this November.  

The long-awaited TCET final notice doesn’t address major concerns, medtech industry advocates say.