FDA de novo clearance

Above: Alon Ironi, CEO & Co-Founder, Theranica. Credit: Theranica

By Dean Koh June 16, 2019
Pain is usually an indication something wrong with the body and the typical approach to pain is to take appropriate medicine that will help alleviate that pain. However, taking painkillers will have some side effects and it is more complicated, or even life-threatening for those who are allergic to certain painkillers. Imagine a future where pain can be managed or alleviated using a combination...
By Dave Muoio June 10, 2019
The FDA has granted De Novo clearance to a prescription nerve stimulation device for the reduction of functional abdominal pain. The device is intended for use by adolescents and teens with irritable bowel syndrome in combination with other therapies. Developed by Innovative Health Solutions, the IB-Stim devices is a single-use electrical nerve stimulator. When placed behind the patient’s ear, it...

An illustrated graphic of how the Nerivio Migra device works. Source: Theranica

By Dean Koh May 28, 2019
Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilising Remote Electrical Neuromodulation for the acute treatment of migraine. The FDA...
By Dave Muoio February 19, 2019
Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers. The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of...
By Dave Muoio December 4, 2018
De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges submitted devices. “Our goal is to make the De...
By Dave Muoio November 14, 2018
De Novo clearance for urinary incontinence wearable. The FDA has granted De Novo clearance to Atlantic Therapeutics’ Innovo therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence. The wearable is intended for adult women as a front-line or second-line therapy, and in a multi-center randomized controlled trial recorded an 87 percent rate of...
By Dave Muoio October 31, 2018
Yesterday afternoon the FDA announced that it would permit 23andMe to market its Personal Genome Service Pharmacogenetic Reports test. The test offers consumers information on whether they posses one of 33 variants across multiple genes that could impact their body’s ability to metabolize certain medications. The purpose of this test is to inform patients and encourage them to more thoroughly...
By Dave Muoio August 10, 2018
The FDA announced today that it will allow marketing of Natural Cycles’ contraception app in the US for pre-menopausal women aged 18 years and older. Previously approved in the UK and currently the subject of investigation by multiple regulatory agencies, the algorithm-driven app helps users track their menstrual cycle and informs them when they are most fertile. “Consumers are increasingly using...
By Dave Muoio February 14, 2018
The FDA announced yesterday that it will permit marketing of Viz.ai’s Contact, a clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke. The CDS application was submitted through the agency’s de novo premarket review pathway, and as such creates a new regulatory classification for similar AI-drived platforms to come. The FDA’s...
By Jonah Comstock September 14, 2017
In an FDA first, Boston- and San Francisco-based Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the agency. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease. “This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey...