Jun 16,2020

FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

The U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to 12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. The FDA reviewed the EndeavorRx through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

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Oct 21,2020

AppliedVR Receives FDA Breakthrough Device Designation to Treat Pain with Digital Therapeutic

AppliedVR, a pioneer advancing the next generation of digital medicine, today announced its EaseVRx product received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for treating treatment-resistant fibromyalgia and chronic intractable lower back pain. EaseVRx is now one of the first virtual reality (VR) digital therapeutics to get breakthrough designation to treat conditions related to chronic pain.

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Oct 26,2020

Nerivio® Receives Clearance of Expanded Indication to Cover Chronic Migraine Patients

Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® medical device has received Food and Drug Administration (FDA) clearance for an expanded indication encompassing acute treatment of chronic migraine in people 18 years and older.

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Nov 09,2020

FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder

The FDA granted Minneapolis-based NightWare a De Novo clearance on Friday for its Apple Watch and iPhone app designed to improve the sleep quality of those experiencing nightmare disorder and nightmares related to PTSD. The digital therapeutic – which received breakthrough designation from the agency last year – uses the Watch's sensors to track the heart rate and movement of users as they sleep. The application then vibrates the smartwatch just enough to interrupt the wearer's dreaming, but not enough to wake them up or disrupt their circadian sleep cycle.

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Dec 08,2020

CBT digital therapeutic for IBS patients receives FDA De Novo clearance

The FDA has granted a De Novo clearance to San Francisco-based Mahana Therapeutics' Parallel, a prescription digital therapeutic for patients with irritable bowel syndrome (IBS) that delivers cognitive behavioral therapy (CBT). The three-month digital treatment logs a patient's symptoms and uses them to deliver relevant guidance. In addition, the digital CBT teaches patients skills and habits to help them manage their condition.

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Oct 04,2019

Biofourmis Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring

Boston-based Biofourmis has received 510(K) clearance for its machine-learning and artificial intelligence (AI)-powered analytics engine as a medical device for ambulatory physiological monitoring. This regulatory approval is part of the FDA’s growing recognition of machine-learning and AI in the Software as a Medical Device category.

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Jul 31,2019

Voluntis announces market authorization for Oleena™, first digital therapeutic in oncology

Voluntis, a leader in digital therapeutics, today announced it has successfully completed a U.S. Food and Drug Administration (FDA) regulatory review of its Oleena™ software for oncology-related symptoms management and remote patient monitoring. Oleena™ is determined as Class II medical device falling under enforcement discretion per FDA Guidance. Oleena™ is a care companion for the cancer patient journey based on mobile and web technologies that enables self-management of symptoms and remote monitoring by care teams.

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Feb 06,2019

Cognoa Receives FDA Breakthrough Designations for Autism Diagnostic and Digital Therapeutic Devices

Cognoa, a company at the forefront of digital behavioral health for children, today announces it has received Breakthrough Device designations from the U.S. Food and Drug Administration (FDA) for its lead products, the first digital diagnostic and digital therapeutic devices for autism. These products are the foundation of Cognoa’s precision health platform designed to support earlier identification and treatment of pediatric behavioral health conditions. Today, most children in the US who receive an autism diagnosis, and subsequent treatments, do so after the age when interventions have the greatest opportunity to impact the lifetime trajectory of the child.

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May 02,2019

FDA clears Biofourmis' software for ECG-based arrhythmia detection

The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics, a cloud-based software product that uses deep learning to read and interpret cardiac arrhythmias. According to a statement from the company and the FDA’s clearance letter, RhythmAnalytics collects single-lead ECG data from a range of FDA-cleared devices, and from these scan for more than 15 types of cardiac arrhythmias, including ventricular arrhythmia, ventricular ectopic beats and non-paced arrhythmias, such as atrial fibrillation.

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May 24,2019

NightWare Awarded FDA “Breakthrough Status” for PTSD Apple Watch App

NightWare, Inc., digital therapeutics for mental health company has received Breakthrough Status designation from the U.S. Food and Drug Administration (FDA) for its NightWare Apple Watch app that measures and treats nightmares in people with Post-Traumatic Stress Disorder (PTSD).

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