PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking comments from stakeholders on whether certain self-testing in vitro diagnostics (IVDs) should be prohibited from being sold to consumers.

A large-scale U.K. clinical trial of a portable electronic nose device has shown it is possible to distinguish bacterial from viral infection in an unselected population of patients presenting with a respiratory tract infection (RTI) symptoms, at the point of care.

Healthy.io had plenty of news to report last week. To begin, the Tel Aviv, Israel-based company, which is focusing on turning the smartphone camera into a clinical-grade medical device, now has a second clearance. In addition, the company closed a $60 million series C funding round.

The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.