Jul 07,2022

Renovia’s breakthrough tech gets FDA OK for new incontinence indication

The US FDA has given Renovia’s Ieva pelvic health system the green light to be marketed as a first-line treatment for chronic faecal incontinence (FI) in women. The 510(k) clearance comes less than nine months after the technology, designed for home use, was granted FDA breakthrough device status. leva is already cleared and being commercialised as a treatment for stress, mixed and mild-to-moderate urinary incontinence (UI) in women.

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Nov 29,2022 TOP STORY

FDA clears Apple Watch app for tracking Parkinson’s from H2o Therapeutics

H2o Therapeutics announced recently that the FDA cleared its prescription mobile app, Parky, for monitoring Parkinson’s disease. Ankara, Turkey–based H2o’s Parky app monitors symptoms including tremors and dyskinesia in real-time through the Apple Watch. In addition, the tool allows users and medical professionals to share meaningful and reliable data.

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Jul 30,2021

Biofourmis Earns FDA Breakthrough Device Designation for Digital Therapeutic for Heart Failure

Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).

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Aug 17,2021

Swing Therapeutics lands FDA breakthrough designation for fibromyalgia platform

Digital therapeutics (DTx) startup Swing Therapeutics has been granted FDA Breakthrough Device Designation for its smartphone-administered fibromyalgia management program. Swing’s 12-week DTx uses acceptance and commitment therapy (ACT), forms of cognitive behavioral therapy (CBT) that help patients accept factors outside of their control and focus on making internal changes. The program includes daily learning lessons and interactive sessions that help users understand their circumstances and develop skills to manage their condition.

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Mar 02,2021

Relivion® Wearable Brain Neuromodulation Technology Cleared by FDA for the Treatment of Migraine

Neurolief, an innovator in neurotechnology, announces the company has received Food and Drug Administration (FDA) clearance for its Relivion® system. Relivion® is the first non-invasive multi-channel brain neuromodulation system for at home treatment of acute migraine, a debilitating neurological disease impacting 39 million people and resulting in 1.2 million emergency department visits annually.

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Mar 09,2021

Mahana Therapeutics Obtains CE Mark for Parallel™ in the UK

Mahana Therapeutics, an emerging leader in prescription digital therapeutics, announced today that it has obtained a CE mark for its flagship product Parallel™. Parallel is the first prescription-only digital therapeutic (PDT) intended to reduce the severity of irritable bowel syndrome (IBS) symptoms in adult patients.

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May 12,2021

Voluntis receives CE Mark for new version of Oleena with expanded clinical intelligence

Voluntis, a leader in digital therapeutics, today announced that it has received the CE mark for a new version of Oleena featuring expanded clinical intelligence. Oleena is Voluntis’ proprietary digital therapeutic that supports patients in the self-management of their symptoms in combination with a wide range of cancer treatments, while allowing healthcare teams to remotely monitor the progress of the disease. It is based on the Theraxium platform developed by Voluntis, which also serves as the foundation for the digital therapeutics the company is co-developing with pharmaceutical partners.

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May 14,2021

One Drop Receives CE Mark for AI-Powered Blood Glucose Forecasts

One Drop, a leader in precision health solutions for people living with chronic conditions, today announced it has achieved the Conformité Européenne (CE) Mark for its Blood Glucose Prediction Analysis Engine-1 to accurately forecast glucose levels up to eight hours in advance for people living with prediabetes, type 2 diabetes, and gestational diabetes.

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May 26,2021

One Drop Receives CE Mark, Launches Data-Driven Insights for People Managing High Blood Pressure

One Drop, a leader in precision health solutions for people living with chronic conditions, today announced it has received the Conformité Européenne (CE) Mark for its Blood Pressure Trend and Analysis Engine-1 to generate blood pressure (BP) insights. As part of the One Drop Digital Membership, consumer and employer members worldwide can now receive in-app messages with blood pressure trends, behavioral reinforcements, and alerts for hypertensive crises.

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May 26,2021

Digital chatbot Woebot lands FDA breakthrough designation to tackle postpartum depression

Digital mental health company Woebot Health has landed FDA Breakthrough Device Designation for its postpartum depression digital therapeutic, WB001. WB001 combines cognitive behavioral therapy and elements of interpersonal psychotherapy with the company’s conversational chatbot, Woebot, to deliver treatment directly through patients’ phones.

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