digital therapeutic

By Dave Muoio and Laura Lovett 03:45 pm September 27, 2019
It’s been two years since the first software-only digital therapeutic got the FDA greenlight, but the industry is still very much in its infancy and continuing to evolve. New entrances are emerging from the world of health, pharma, tech and finance. As the industry matures, it's grappling with existential questions including regulation, reimbursement models and, as always, the definition of a...
By Laura Lovett 04:22 pm September 25, 2019
There’s no denying that digital therapeutics look and feel different than traditional medications. Instead of popping open a medication bottle, users are logging into an app to access treatment. But the differences don’t stop at the look. While the risk of toxicity is an ever-looming question in the pharma space, the same isn’t true for digital solutions.  Stakeholders at the digital therapeutics...
By Dave Muoio 03:30 pm August 6, 2019
Paris, France-based Voluntis has received FDA marketing authorization for an algorithm-driven digital tool that helps cancer patients manage their symptoms and care teams identify clinical insights, the company announced last week. The Oleena software is a Class II medical device that is prescribed by the patient’s care team. As the user logs their symptoms into the app, it adapts to offer...

Omada CEO Sean Duffy. Photo credit: Omada

By Laura Lovett 03:57 pm July 11, 2019
Omada Health, the digital health company that recently raised $73 million, came on to the digital health scene in 2011 with a focus on diabetes and chronic conditions. As the company continues to carve out its legacy in the digital health world, it is taking a cue from a more established industry. “We’re one of the most life sciences-like digital health companies. We don’t fit perfectly into any...
By Dave Muoio 03:48 pm May 21, 2019
Minneapolis-based NightWare — maker of a smartwatch therapeutic for people with nightmare disorder and PTSD-driven nightmares — has received breakthrough therapy designation for its in-development product. In addition, the company is launching two new placebo-controlled randomized clinical trials for its digital intervention, one of which is being conducted within Department of Veterans Affairs...
By Dave Muoio 11:32 am May 8, 2019
A randomized controlled trial recently published in npj Digital Medicine found Kaia Health’s app-based exercise therapy for lower back pain (LBP) to be an effective treatment for multidisciplinary patients, and could be more effective than a standard strategy of individual physiotherapy sessions paired with online education. TOPLINE DATA In the investigation — which was sponsored by Kaia Health...
By Laura Lovett 01:14 pm January 31, 2019
Fifty-four percent of consumers are willing to try an FDA-approved app or digital tool for the treatment of a medical condition, according to a new report out of PricewaterhouseCoopers compiling survey data and other health trend information from the past year.  “The arrival of digital therapeutics — an emerging health discipline that uses technology to augment or even replace active drugs in...
By MobiHealthNews 11:25 am December 26, 2018
The pharma industry has become increasingly interested in the digital health space over the last few years, but this quarter numerous projects that have been in the works for years have finally came to fruition. For instance, Pear's reSET, the first digital therapeutic cleared by the FDA, was recently launched to commercial markets.  But that wasn’t the only advance in the space as pharma...
By Laura Lovett 05:37 pm December 10, 2018
The FDA has officially cleared reSET-O — a digital therapeutic to treat opioid use disorder (OUD) jointly developed by Pear Therapeutics and Sandoz, a division of Novartis — a little over a year after it was granted an Expedited Access Pathway designation from the agency.  This announcement makes reSET-O the first digital therapeutic to treat patients with OUD. Patients will need a valid...