Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke.
PERTH, Australia – On the heels of an AU$5 million ($US3.47 million) capital raise, digital health company Respiri Ltd. is preparing to launch its digital wheezo asthma measurement device in Australia as it transforms itself from a device manufacturer to an eHealth software as a service company (SaaS). Melbourne-based Respiri received its first batch of 500 wheezo devices in March, and the company plans to deploy them in Australia this quarter.
Before becoming the global head of Johnson & Johnson External Innovation, William Hait spent 30 years in academic medicine focused on oncology. Whenever he speaks to a group, the first question he asks is if there is anyone in the room that would like to get a disease.
The FDA's revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making.
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 to address depressive symptoms in multiple sclerosis (MS).
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct-acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.