Digital Health bits | May 6th 2020
Digital therapeutic makers see opportunity as pandemic prompts FDA to ease rules
A new FDA policy aiming to boost access to digital health devices for treating psychiatric disorders during the COVID-19 pandemic is creating new opportunities for digital therapeutic manufacturers.
Akili Interactive Labs, a Boston-based company that seeks to deliver digital medicine through video games, began rolling out its still-under-review ADHD treatment Wednesday at no cost to qualifying users under the policy, which like FDA’s other COVID-19 guidance documents applies for the duration of the public health emergency.
Pear Therapeutics, which already markets three FDA-cleared app-based treatments for substance use disorder, opioid use disorder, and chronic insomnia, said teleprescribing for its products has jumped amid social distancing and it's looking at other treatments in its pipeline that meet the agency's criteria during the pandemic.
#DigitalHealth #DigitalTherapeutics #COVID-19
Pear rolls out digital therapeutic for schizophrenia, after FDA loosens regulations in COVID-19 response
Pear Therapeutics is rolling out its new digital therapeutic aimed at treating schizophrenia for limited distribution, after the FDA loosened up its regulations for digital psychiatric disorders devices during the coronavirus crisis.
The new tool, called Pear-004, uses multimodal neurobehavioral interventions combined with antipsychotic medications. Patients with schizophrenia can use the tool for social skills training, cognitive behavioral therapy for psychosis and for illness self-management training. Pear-004 has to be used under a doctor’s supervision. The company is collaborating with select healthcare providers and academic institutions for the initial distribution.
Two weeks ago, the FDA came out with a new guidance that waives several regulatory requirements for devices aimed at treating psychiatric disorders including submission of 510(k) premarket notifications, reports of corrections and removals requirements, registration and listing requirements, and unique device identification (UDI) requirements.
#DigitalHealth #DigitalTherapeutics
French firm Withings launches under-the-mattress sleep tracking mat
French digital health firm Withings has unveiled its latest sleep-tracking device - a mat which can be used to detect sleep apnea.
When placed underneath a mattress, Sleep Analyzer uses its advanced sensors to analyse sleep and snoring episodes.
It utilises a pneumatic sensor to measure respiratory rate, body movement and continuous heart rate in order to track users’ sleep cycles (deep, light, and REM) and cycle durations, as well as overall sleep duration.
The technology also uses a sound sensor to detect snoring. Users can check the number of snoring episodes they experienced and their durations in the accompanying Health Mate app. Results can then be shared with physicians and sleep specialists.
Sleep Analyzer launched in the EU and UK this week, after receiving CE marking for medical devices. It has been crafted in conjunction with sleep experts and clinically validated to provide medical-grade analysis and sleep apnea detection.
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European telehealth start-up Kry lands in the US as coronavirus creates spike in demand
Swedish digital health start-up Kry has launched a video consultation platform in the U.S., marking the firm’s first expansion beyond Europe.
The Stockholm-based company is one of Europe’s largest digital health care providers, facilitating 1.8 million consultations to date. Its closest competitor is Britain’s Babylon, which has racked up over 2 million consultations.
Kry — known in English-speaking markets as “Livi” — isn’t bringing its main app to the States. Instead, it’s rolling out Livi Connect, a free video consultation platform with less features, in response to a spike in demand caused by the coronavirus pandemic.
Johannes Schildt, Kry’s CEO and co-founder, said a full launch could be a potential revenue driver for the company down the line, but added such a move would depend on how well its Livi Connect product performs “post-pandemic.”
#DigitalHealth #TeleHealth
COVID-19 gives Akili’s digital ADHD treatment an early debut in US
An app to treat children with attention-deficit hyperactivity disorder (ADHD) developed by Akili has been made available ahead of its FDA approval, under an agency scheme to speed up access to digital therapies during the coronavirus pandemic.
The app – called Endeavor (AKL-T01) – aims to improve children’s ability to focus by asking them to manage competing tasks and to shift attention between tasks using video game-like graphics and digital rewards.
Boston, US-based Akili, an affiliate of UK group PureTech Health, is still in the process of seeking FDA approval of the digital therapy as a prescription treatment. However, it has been able to offer it to children with ADHD and their families early because the FDA has relaxed regulations covering digital health devices for psychiatric conditions during the COVID-19 outbreak.
Just-published guidance from the regulator has introduced enforcement discretion for low-risk digital therapies that have clinical evidence to back up their efficacy, to support patients who may not be able to access their usual health services during lockdown.
Earlier this year, Akili reported the results of a randomised trial involving 348 children aged eight to 12 who played Endeavor or a control app for 25 minutes a day on weekdays for a month. They came off any ADHD medications before the study to stop these affecting the results.
#DigitalHealth #DigitalTherapeutics
Read more: https://pharmaphorum.com/news/covid-19-gives-akilis-digital-adhd-treatment-an-early-debut-in-us/
France's COVID-19 Tracing App Expected to Enter Testing in Week of May 11
France's state-supported "StopCOVID" contact-tracing app should enter its testing phase in the week of May 11 when the country starts to unwind its lockdown, a government minister said on Sunday.
Minister for Digital Affairs Cedric O, a member of President Emmanuel Macron's inner circle, presented the app as a key element of France's strategy to stave off the coronavirus as authorities grapple with the prospect of mass testing.
"There's nothing magical about this app, but it's not technological coquetry either," O wrote on online publishing platform Medium. "It's only useful if it's integrated into a global health system."
Countries are rushing to develop apps to assess the risk of one person infecting another, helping to isolate those who could spread the disease.
#DigitalHealth #COVID-19
Read more: https://www.nytimes.com/reuters/2020/05/03/technology/03reuters-health-coronavirus-france.html
Note: Opinions expressed are solely my own and do not express the views or opinions of my employer