FDA

EchoGo helps earlier detection of cardiovascular disease, enabling clinicians to improve patient care and outcomes.

Also: Apple makes another cardiology hire; Blink Health brings on legal counsel.

This is the seventh FDA clearance for the longstanding mobile diabetes management platform.

Epstein Becker & Green's Bradley Merrill Thompson explains why the FDA PreCert Program's built-in subjectivity and bias toward established entities should worry the healthcare and medical technology industry.

Senators Elizabeth Warren, Patty Murray and Tina Smith continued to express concerns about the PreCert's 'Excellence Appraisals,' De Novo pathway and real-wrold performance markers.  

Cognoa and MedRhythms will be kicking off multi-site investigations of their tools, which are designed for pediatric autism diagnosis and stroke rehabilitation, respectively.

Also: ResApp announces results of prospective study on obstructive sleep apnea; Cosnumer telemedicine company Hims opens pharmacy operation in Columbus, Ohio. 

Digital therapeutic stakeholders came together at this week's DTx East conference to discuss the state of digital health investment, developing successful business models, the need for robust data and more.

The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.

The new tool is a clinical-grade ACR test used to identify chronic kidney disease.