Prescription Digital Therapeutics

Lisa Rometty, CEO at Zerigo Health, discusses the challenges and opportunities for growth within the digital health landscape, as well as how Zerigo plans to collaborate with patients and payers to make sure digital health tools are accessible and affordable.

When compared to a double reading of a mammogram screening by two radiologists, a double reading by one radiologist plus AI demonstrated a 4% higher non-inferior cancer detection rate, highlighting the potential of AI in enhancing cancer detection in mammography screening.

Mahana’s company’s irritable bowel syndrome digital therapy was the first to digital therapy to gain clearance from the FDA.

Akili executives said a focus on non-prescription digital therapies removes the barriers payers place on access and creates a more sustainable business.

The first-ever machine learning-based model was developed to provide preoperative predictions of weight trajectories up to 5 years after surgery, simultaneously for three of the most common types of bariatric surgery.

However, patients who cannot get insurance coverage will be able to access AspyreRx at a significant self-pay discount.

In two-thirds of published studies, digital therapeutics were found to be cost-effective, and they led to cost savings in most of the other studies. However, most of the research was funded by industry and that might limit its impact.

More than half of participants completed the eight-week course, the authors said.

Big Health CEO Arun Gupta says digital therapeutics companies must "rigorously engage” with payers and focus on broad adoption of their products.

Although they used the app, participants referred by the legal system typically used it to connect with social workers or other services.

The study found the pricing for the therapy made it unlikely to be more cost-effective than in-person physical therapy.

Many countries still do not have official frameworks with which to evaluate digital therapies.

The product specifically looks at the potential to address negative symptoms of schizophrenia through digital health tools.

The company says the video game-based therapy improved measures of attention and quality of life for adults with ADHD.

A new study shows a digital therapeutic for insomnia works, but with important caveats.

The digital therapy product combines cognitive behavioral therapy with financial incentives to encourage abstinence. Lack of side effects may be a selling point.

GrayMatters Health hopes to use its technology for other mental health indications in the future.

People in urban and rural areas saw similar improvement from a digital health program that comprised patient education, an exercise program, and cognitive behavioral therapy.

The development comes after a study showed users had four fewer days per month with migraine symptoms.

By clustering patients based on self-reported data, investigators said they may be able to predict which patients are most likely to respond to a digital therapy.

The goal of the application programming interface (API) is to ensure accurate data collection without burdening patients or biasing the data.

Leaders of the Digital Therapeutics Alliance hope to get a Congressional Budget Office score on the legislation that would extend Medicare coverage so members of Congress can weigh budget implications.

Digital therapeutics are regulated like devices by the FDA. Andy Molnar, the CEO of the industry’s trade organization, the Digital Therapeutics Alliance, says the FDA clearance and authorization process for digital therapeutics “works.”

A new study showed a smartphone app is associated with improvements in HbA1c levels and other measurements indicative of well-managed diabetes. The authors note, though, that benefit may come from greater physician involvement with patients and other factors related to the app.

Digital therapies for migraine have been studied extensively in recent years, and the number of products on the market is likely to expand.

Developer of EndeavorRx, a game-based treatment for ADHD, is pulling back from the pipeline and focusing on near-term growth, the CEO said in an email to employees.

Pear also recently announced a deal with California's Medicaid program that involves supporting a pilot project to help people with stimulant use disorder.

Medi-Cal, California's Medicaid program, has contracted with Pear Therapeutics for members in 24 counties to participate in an outpatient program for stimulant use disorder.

A small (23 patients) pilot study showed improvements symptoms and quality of life.