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.

REGULATORY FDA

#virtual reality

#connected device

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#pdt

#connected device

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#mobile app

#connected device

View Analyst & Ambassador Comments
Go to original news
Nov 16,2020

Voluntis Receives CE Mark for Oleena, Key Milestone to the Future Commercialization of Its Digital Therapeutics for Oncology

Voluntis, a leader in digital therapeutics, today announced that it has received the CE mark for Oleena. Oleena is Voluntis’ proprietary digital therapeutic that enables patients to self-manage symptoms across a wide range of cancer therapies, and also allows care teams to remotely monitor patients. Oleena is based on Voluntis’ Theraxium platform, and its patented algorithm engine, which also serves as the foundation for digital therapeutics the company co-develops with life science partners.

REGULATORY CE MARK

#mobile app

#rpm

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#pdt

#cbt

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#connected device

#software

View Analyst & Ambassador Comments
Go to original news
Jul 25,2019

DarioHealth USB Type C Connector for the European Android Market Is CE Marked

Global digital therapeutics innovator DarioHealth, today announced that its CE certificate covers a USB-C connector enabled version of the acclaimed Dario™ Blood Glucose Monitoring System. The USB-C connector is used to transfer power and communication signals between Android smart mobile devices and the Dario meter, and ensures that consumers, beginning with the Europe market region, will receive the same quality user experience with DarioHealth on the latest Android smart phone devices.

REGULATORY CE MARK

#mobile app

#connected device

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#mobile app

#rpm

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#connected device

View Analyst & Ambassador Comments
Go to original news
Mar 06,2019

Voluntis receives CE Mark to add NPH/isophane to Insulia

Today, Voluntis announced that it had obtained the CE mark for the new version of Insulia that integrates intermediate-acting neutral protamine Hagedorn (NPH) insulin, also known as isophane insulin. Insulia is the first digital therapeutic with regulatory clearance to provide automated titration recommendations for all types of basal insulin, including NPH insulin as well as all first and second generation long-acting basal insulin analogs.

REGULATORY CE MARK

#mobile app

View Analyst & Ambassador Comments
Go to original news
Subscribe to REGULATORY