Jun 02,2021

Cognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid

Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid. The AI-based device is the first FDA-authorized diagnosis aid designed to help physicians to diagnose autism in the primary care setting.

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Oct 20,2021

Luminopia Announces FDA Approval of Digital Therapeutic to Improve Vision in Children with Lazy Eye

Luminopia, a digital therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo premarket approval for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye), the leading cause of vision loss in children. Luminopia One is indicated for improvement in visual acuity in children with amblyopia, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions as prescribed by a trained eye-care professional.

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Nov 16,2021

FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction

The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

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Nov 22,2021

Pear scores Breakthrough Device Designation for digital therapeutic aimed at alcohol use disorder

Pear Therapeutics announced Monday it had received Breakthrough Device Designation from the FDA for its prescription digital therapeutic aimed at treating alcohol use disorder, reSET-A. The news comes just ahead of the company’s planned merger with a special purpose acquisition company, Thimble Point Acquisition Corp., which will allow it to trade publicly. Pear already has FDA-cleared digital therapeutics for substance abuse disorder, opioid use disorder and chronic insomnia. The Breakthrough Device Designation isn’t a marketing approval from the FDA, but it aims to accelerate review of products that could help treat debilitating or life-threatening conditions.

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Dec 07,2021

FDA clears digital therapeutic for abdominal pain from IBS

MetaMe Health, a startup building an app-based treatment to help alleviate some of these symptoms, recently received FDA clearance for its digital therapeutic, called Regulora. It’s built around research by University of North Carolina psychologist Olafur Palsson, who studies the use of psychological treatments for IBS and other GI disorders.

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Jan 25,2021

FDA Approves Theranica’s Nerivio® for Acute Treatment of Migraine in Adolescents

Theranica, a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® therapeutic device has received the Food and Drug Administration clearance to market for an expanded indication for acute treatment of episodic or chronic migraine in people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache.

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Mar 31,2022

Optellum wins CE mark for AI-powered early lung cancer diagnostic tech

Oxford, England-based Optellum designed the Virtual Nodule Clinic as a clinical decision-support tool for helping clinicians identify and track at-risk patients who present suspicious lung nodules that may or may not be cancerous. The platform received FDA 510(k) clearance in March 2021.

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May 03,2022

FDA clears iSono’s automated, wearable 3D breast ultrasound system

iSono Health announced today that the FDA cleared its Atusa system for whole-breast ultrasound imaging. South San Francisco, California–based iSono designed Atusa as a first-of-its-kind, compact, automated whole-breast ultrasound system with a unique wearable accessory and intuitive software for automated image acquisition and analysis.

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May 27,2022

DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes

DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px Colorectal deep learning algorithm. Oslo, Norway-based DoMore designed its Histotype Px Colorectal deep learning algorithm to predict colorectal cancer patient outcomes based on analysis of digital histology images.

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Jul 01,2022

FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy

Intuitive (Nasdaq:ISRG) announced that the FDA cleared an integration of imaging technology with the Ion robot-assisted bronchoscopy system. The integration covers a mobile cone-beam CT (CBCT) imaging technology, developed by Siemens Healthineers, called Cios Spin. The integration of Ion with Siemens’ imaging technology could improve the accuracy of biopsy procedures, aiding in the diagnosis of lung cancer, the company said, through the enhancement of a physician’s ability to provide minimally invasive lung biopsy with Ion and potentially give patients answer sooner.

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