Jul 22,2015

Propeller Health Receives FDA Clearance for the Propeller Platform in Association with Boehringer Ingelheim’s Respimat® Inhaler and GlaxoSmithKline’s Diskus® Inhaler

Propeller Health, the FDA-cleared digital health solution for chronic respiratory disease, today announced U.S. Food and Drug Administration 510(k) clearance to market its Propeller platform in association with medications using GlaxoSmithKline’s Diskus® dry powder inhaler (DPI) device for asthma and chronic obstructive pulmonary disease (COPD). This new clearance follows 510(k) clearance to market the Propeller platform in association with medications using Boehringer Ingelheim’s Respimat® inhaler for chronic obstructive pulmonary disease (COPD) received in March 2015.

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Jun 16,2021

Amalgam Rx Receives CE Mark for Basal Insulin Titration

Amalgam Rx, Inc., the leader in connecting healthcare providers and life sciences companies through a SaaS-enabled digital marketplace and product platform, is announcing it has achieved the Conformité Européenne (CE) Mark for its insulin titration application, iSage RxTM and its white-labeled variants. The CE Mark demonstrates Amalgam's commitment to EU standards for quality management, safety, and performance as defined in the Medical Devices Directive 93/42/EEC.

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Mar 26,2020

Pear Therapeutics Obtains FDA Authorization For Somryst, A Prescription Digital Therapeutic For The Treatment Of Adults With Chronic Insomnia

Pear Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted authorization for Somryst™, the first prescription digital therapeutic (PDT) intended for use in the treatment of patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms, and it is the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0.

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Apr 14,2020

FDA Grants The Learning Corp Breakthrough Device Designation for Speech Therapy App

The Learning Corp, an award-winning digital therapeutics provider, today announced that it has received Breakthrough Device designation from the United States Food and Drug Administration (FDA) for its Speech Therapy (ST) App, which is designed to provide accessible cognitive, speech and language therapy to stroke patients. The first cognitive linguistics application to achieve this status by FDA, ST App’s Breakthrough Device designation is also the first for The Learning Corp, which combines AI and real-world evidence to deliver next-generation brain health products and research. ST App is designed as an accessible, home-based therapy solution for patients that also allows clinicians to check in remotely on progress.

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Jun 01,2020

Blue Note Therapeutics Receives Breakthrough Device Designation from FDA for Prescription Digital Therapeutic to Treat Cancer-Related Anxiety and Depression

Blue Note Therapeutics, Inc., a prescription digital therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to BNT001, the company’s lead prescription digital therapeutic (PDT) candidate for the treatment of symptoms of anxiety and depression related to cancer in adult patients.

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Jun 03,2020

BlueStar's eighth FDA clearance adds long-acting basal insulin support for Type 2 patients

WellDoc's BlueStar chronic disease-management tool has picked up another 510(k) FDA clearance that will allow it to support adult Type 2 diabetes patients using long-acting basal insulin. The feature was announced by WellDoc this morning, but cleared by the agency in April, according to a listing on its website. The new capability takes the form of a new program within the prescription BlueStar app, called the Insulin Adjustment Program. Healthcare providers use a web-based interface to prescribe an initial dose of long-acting basal insulin, which the new feature then uses to guide patients with subsequent titrations.

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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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Jun 23,2020

Akili Announces CE Mark Approval of EndeavorRx™ Digital Treatment for Children with ADHD

Akili today announced that it has received Conformité Européenne (CE) Mark certification for EndeavorRx (AKL-T01), as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is one of the most common psychiatric disorders in childhood and nearly 5 percent of children in Europe are diagnosed with the disorder.

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Aug 18,2020

NuvoAir respiratory platform receives Class Im medical device status

Sweden-based digital therapeutics respiratory company, NuvoAir, has been certified as a Class Im medical device. The NuvoAir Home platform includes Air Next, a certified bluetooth spirometer, a connected patient app and a healthcare portal. Patients can use the platform to self-monitor their respiratory health and share clinically relevant data with their care teams, who can view this data remotely via a healthcare portal.

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Sep 08,2020

Nerivio® Smartphone-Controlled Wearable for Acute Treatment of Migraine Granted CE Mark for Use in Europe

Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, today announced that it has been granted a CE mark for its Nerivio® device for acute treatment of migraine, a little more than a year after receiving FDA clearance in the United States. This milestone allows the award-winning wearable therapeutic device to be marketed in select countries in Europe, as part of the company's roll-out plan, starting in 2021

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