Regulation

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...
A parent and a child talking to a doctor
By  Emily Olsen 02:04 pm April 13, 2022
Pediatric behavioral health company Brightline is launching a virtual coaching program aimed at parents and caregivers with children at risk for or diagnosed with autism spectrum disorder (ASD). Getting an Early Start on Autism includes one-on-one sessions with an autism care coach as well additional educational content and exercises. The program is geared toward caregivers with children ages 18...
Doctors looking at patient data on a monitor
By  Emily Olsen 12:06 pm April 13, 2022
Alio announced it earned FDA 510(k) clearance for its remote monitoring system that collects data on skin temperature, auscultation, or internal body sounds, and heart rate. The system, which received the greenlight in late March, is made up of the SmartPatch wearable sensor, its Bedside Hub which collects and uploads patch data, the Alio Medical Cloud that stores that information, and a...