Regulation

A box containing Cerebral prescriptions
By  Emily Olsen 11:18 am June 16, 2022
Digital mental health company Cerebral is under investigation by the Federal Trade Commission, according to a letter sent by the agency and reviewed by the Wall Street Journal.  According to WSJ, the FTC is investigating whether Cerebral was involved in deceptive or unfair marketing or advertising practices, including raising questions about programs where the virtual mental health company...
A woman using a smartwatch
By  Emily Olsen 11:42 am June 14, 2022
Brain data startup Rune Labs announced Tuesday it received FDA 510(k) clearance to use its StrivePD app to monitor Parkinson's disease patients' symptoms through the Apple Watch. The StrivePD system uses Apple's Movement Disorder API to track tremors and dyskinesia, or uncontrolled, involuntary body movement. Patients can also use the app to log their medications, side effects and other symptoms...
A parent with a toddler at a doctor's appointment
By  Emily Olsen 11:15 am June 13, 2022
EarliTec Diagnostics announced it has received FDA 510(k) clearance for a device that helps clinicians identify autism spectrum disorder for children between the ages of 16 and 30 months old. The tool, called EarliPoint Evaluation, uses eye-tracking technology to monitor a child's looking behavior while they watch short videos of other children interacting with one another. The technology...
Doctors looking at imaging results
By  Emily Olsen 11:51 am May 24, 2022
RapidAI, a health tech company that specializes in stroke imaging analysis, announced Tuesday it had received FDA 510(k) clearance for its product that aims to identify potential cases of central pulmonary embolism and alert providers. The Rapid PE Triage & Notification tool analyzes CT pulmonary angiogram (CPTA) images and alerts care teams when it finds a suspected case, so providers can...
A box containing Cerebral prescriptions that reads "Let's take your first step toward recovery, together."
By  Emily Olsen 04:35 pm May 18, 2022
Cerebral CEO and cofounder Kyle Robertson is leaving his position at the digital mental health company amid growing controversy over its prescribing practices, particularly for controlled substances like Adderall. Dr. David Mou, who has served as Cerebral's president and chief medical officer, will be taking the reins as CEO effective immediately. Mou added the president role earlier this month....
ORCHA, digital therapeutics, DTx Project, digital health patient engagement, mental health, COVID-19
By  Tammy Lovell 07:11 am May 17, 2022
Demand for mental health services has soared since the COVID-19 pandemic. In the UK alone an estimated 1.6 million people are awaiting treatment, while a further eight million who do not qualify for NHS help are experiencing day-to-day challenges. Increasingly digital therapeutics (DTx) are being considered as an option to fill the gaps in healthcare provision. They have the potential to be woven...
A gavel next to a stethoscope
By  Emily Olsen 10:41 am May 13, 2022
In the wake of a leaked Supreme Court draft opinion that would overturn Roe v. Wade, abortion access is set to be restricted further across many states in the U.S. About half of the states would likely make abortion illegal or restrict it heavily if Roe is overturned.    But the landscape for abortion access – and women's healthcare, in general – has greatly changed since the case was decided in...
A woman handing her insurance card to a provider
By  Emily Olsen 01:18 pm May 11, 2022
Healthcare price-transparency platform Turquoise Health has raised $20 million in Series A funding. The round was led by Andreessen Horowitz with participation from Bessemer, Box Group and Tiger Global. WHAT IT DOES Turquoise offers a platform where patients can search services and providers for cost information, compare cash prices and input insurance information to find out-of-pocket costs. The...
A pharmacist working at a desk
By  Emily Olsen 11:37 am May 9, 2022
Cerebral is under investigation for possible violations of the Controlled Substances Act as the digital mental health company faces increasing scrutiny over its prescribing practices for medications like Adderall. As first reported by Insider, Cerebral confirmed it had received a grand jury subpoena from the U.S. Attorney’s Office for the Eastern District of New York on the evening of May 4. That...
CureApp's DTx app for hypertension
By  Adam Ang 09:16 pm May 8, 2022
Japan's Ministry of Health, Labour and Welfare has awarded the Japanese medtech startup CureApp a medical device regulatory approval for its digital therapeutic app for hypertension. WHAT IT DOES CureApp's latest DTx app assists patients in maintaining lifestyle improvements as part of their treatment for hypertension. It automatically delivers personalised guidance to users, including advice on...