October 18, 2017
Pear Therapeutics announced today that reSET-O, a digital therapeutic for opioid use disorder, has received an Expedited Access Pathway (EAP) designation from the FDA. The EAP designation doesn't mean that the FDA has cleared the product, only that it has committed to fast-tracking it through the clearance process because of its timely public health value.
“The opioid epidemic continues to...
September 26, 2017
Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras...
September 14, 2017
In an FDA first, Boston- and San Francisco-based Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the agency. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease.
“This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey...
March 17, 2017
The human brain and the seemingly infinite number of health complications that can befall it are complex. As such, there aren’t universally agreed-upon therapies and treatments for conditions ranging from depression and chronic pain to stroke and Parkinson’s disease. But recent, rapid advances in neuroscience research and digital technology are enabling a new wave of tools to gain traction in...
September 15, 2016
As we noted in our in-depth last week, the digital health space is still holding its breath for big pharma and big payers to dive in with serious M&A. At the opening session for Digital Medicine Connect in Boston, a part of EBD Group’s BioPharm America conference, speakers from around the digital health world weighed in on how that landscape is changing.
“When I think about M&A in the...
August 25, 2016
Pear Therapeutics, a Boston and San Francisco-based developer of digital strategies to address a broad range of mental health conditions, has released results of a study showing promising engagement with its program Thrive, which uses a smartphone app along with medication to treat patients with schizophrenia, schizoaffective disorder and bipolar disorder.
Thrive offers 24/7 patient monitoring...
March 3, 2016
So far this year, the digital health funding that MobiHealthNews tracked has surpassed $600 million. In January, digital health companies raised $471 million across 21 deals. This month, funding reached $197 million across 13 deals, although one of those deals was for an undisclosed amount.
More than half of February's funding came from one big deal: MindMaze raised $100 million. An honorary...
February 3, 2016
Pear Therapeutics, which is developing interventions that combine digital tools and medications, has raised $20 million in a round led by 5AM Ventures, Arboretum Ventures, and Jazz Venture Partners, with participation from Bridge Builders Collaborative. The company raised its last round, which was undisclosed, in March 2015.
The company, which has offices in Boston and San Francisco, was founded...
March 23, 2015
Boston and San Francisco-based Pear Therapeutics, not to be confused with Pear Sports, has raised an undisclosed sum in a round led by 5AM Ventures.
The company has developed a product called eFormulations that combines medication for a specific condition with a digital therapy program. The eFormulations product will be prescribed by physicians to their patients.
Depending on the patient's...