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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May 28,2019

FDA Grants Theranica De Novo to Market First Smartphone-Controlled Acute Migraine-Relief Wearable Device

Theranica, a bio-medical technology company developing advanced electroceuticals for migraine and other pain disorders, announced today that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra®, utilizing Remote Electrical Neuromodulation for the acute treatment of migraine.

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Aug 23,2018

FDA grants digital therapeutic for Alzheimer's symptoms Breakthrough Device designation

Dthera Sciences, a San Diego-based developer of clinical and consumer digital therapeutics for individuals with neurodegenerative conditions, announced today that its development stage intervention, DTHR-ALZ, has been granted Breakthrough Device designation by the FDA. DTHR-ALZ is a digital intervention “intended to mitigate the symptoms of agitation and depression associated with major neurocognitive disorder of the Alzheimer’s type,” according to the current proposed indication for use.

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Feb 21,2018

FDA recognizes Cognoa's child development app as autism diagnostic

Palo Alto, California-based Cognoa’s machine learning app for pediatric behavioral health has received categorization from the FDA as a diagnostic medical device for autism, according to an announcement from the company. By analyzing parent-provided information and videos of a child’s natural behavior, the company’s app uses machine learning to provide an assessment of whether that child is developing at the right pace, as well as to evaluate their behavioral health.

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Dec 10,2018

Pear's digital therapeutic reSET-O FDA cleared to treat opioid use disorder

The FDA has officially cleared reSET-O — a digital therapeutic to treat opioid use disorder (OUD) jointly developed by Pear Therapeutics and Sandoz, a division of Novartis — a little over a year after it was granted an Expedited Access Pathway designation from the agency. The prescription digital therapeutic will give users interactive therapy lessons to be use by patients under a clinician's supervision.

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Dec 18,2018

Palo Alto Health Sciences Obtains FDA-Clearance for Freespira in Treating Post-Traumatic Stress Disorder

Palo Alto Health Sciences, Inc. (PAHS) announced today that its flagship digital therapeutic, Freespira®, has been cleared by the FDA as a treatment option for patients diagnosed with post-traumatic stress disorder (PTSD). Freespira is a 4-week, drug-free treatment for PTSD, panic disorder, panic attacks, and other panic symptoms. Patients complete two 17-minute in-home sessions every day for 4 weeks under the supervision by a licensed healthcare provider.

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Jan 19,2017

WellDoc Receives FDA 510(k) Clearance to Offer a Non-Prescription Version of BlueStar® Digital Therapeutic for Type 2 Diabetes

Digital health leader WellDoc announced today that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) class II clearance for a non-prescription version of the BlueStar® digital therapeutic. Based on this clearance, WellDoc will offer BlueStar® and BlueStar® Rx. The non-prescription version will have all the first-in-class features of BlueStar® Rx apart from an insulin calculator.

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Sep 14,2017

Pear Therapeutics gets de novo FDA clearance for reSET, a digital therapeutic for substance abuse

Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the FDA. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease. reSET is a 12-week program designed to treat addiction and dependency on stimulants, cannabis, cocaine, and alcohol. The system is not usable for opioids, but Pear is also seeking clearance for an opioid product called reSET-O.

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Oct 18,2017

DarioHealth Gains CE Mark for iPhone 7 and iPhone 8 Smart Glucose Meter

This ensures that consumers, beginning in the UK market, will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the brand-new iPhone 8.

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