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Home » Topics » Regulatory » De novo

De novo
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De novo key on keyboard

FDA releases another batch of regs for de novo decisions

June 17, 2025
By Mark McCarty
It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.
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Da Vinci Xi robot - Intuitive Surgical

J&J reports completion of first cases with Ottava robotic system

April 15, 2025
By Holland Johnson
Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in development.
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Healgen COVID-Flu OTC test kit

FDA authorizes first home flu and COVID-19 combo test outside EUA

Oct. 8, 2024
By Holland Johnson
The U.S. FDA granted marketing authorization for Healgen Scientific LLC’s Rapid Check COVID-19/Flu A&B antigen test.
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De novo key on keyboard

Digital products lead FDA’s de novo parade for September

Sep. 10, 2024
By Mark McCarty
The U.S. FDA posted a series of de novo decisions Sept. 9, including a digital diagnostic for chronic kidney disease progression by Renalytix AI Inc., of New York, and a digital therapy device for management of fibromyalgia symptoms by Swing Therapeutics Inc., of San Francisco.
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FDA approval seal on blue glittering background

FDA still playing catch-up on de novo device classifications

Sep. 4, 2024
By Mark McCarty
The U.S. FDA is accused of dragging its feet on making public the devices for which it granted market access under the de novo program, and the agency recently been scrambling to bring these decision summaries to light.
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Bone marrow illustration with doctor background

Scopio wins FDA clearance for bone marrow aspirate application

April 18, 2024
By Shani Alexander
The U.S. FDA granted Scopio Labs Ltd. de novo clearance for its artificial intelligence (AI)-powered software which analyzes bone marrow. Scopio’s Full-Field Bone Marrow Aspirate (FF-BMA) system aims to improve patient care by standardizing bone marrow aspirate analysis and elevating diagnostic precision.
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MIRA Virtual Incision

Virtual Incision’s miniature robotic surgery device gets FDA nod

Feb. 26, 2024
By Annette Boyle
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
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Bluewind Revi cuff

FDA blows good news Bluewind’s way with de novo approval for urgency incontinence device

Aug. 18, 2023
By Annette Boyle
The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.
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Masimo Opioid Halo finger monitor and mobile app

FDA grants de novo to Masimo Opioid Halo

April 3, 2023
By Annette Boyle
Masimo Corp.’s Opioid Halo, an opioid overdose prevention and alert system, was granted de novo status by the U.S. FDA. The device detects opioid-induced respiratory depression, the primary cause of opioid deaths. The de novo authorizes the company to make Halo available over the counter and by prescription for use on individuals aged 15 and up.
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PMD 200 platform in operating room

Medasense gets FDA nod for its nociception technology

Feb. 23, 2023
By Annette Boyle
Medasense Biometrics Ltd. received U.S. FDA marketing authorization for its PMD-200 patient monitor with nociception level index (NOL) technology that monitors patients’ physiological response to pain during surgery. NOL uses a multi-parametric sensor platform combined with artificial intelligence (AI) algorithms to generate a ‘signature of pain’ for patients under anesthesia who are also receiving opioids and other analgesics.
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