De novo https://www.bioworld.com/rss en-us Icecure gets FDA nod for Prosense cryoablation in breast cancer holland.johnson@clarivate.com http://www.bioworld.com/articles/724792 Mon, 06 Oct 2025 12:00:00 -0400 https://www.bioworld.com/articles/724792-icecure-gets-fda-nod-for-prosense-cryoablation-in-breast-cancer Illustration of cryoblation procedure in breast The Icecure Prosense system creates an iceball at breast tumor site. Credit: Icecure Medical Ltd. FDA posts another batch of regulations for de novo devices http://www.bioworld.com/articles/723183 Wed, 20 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/723183-fda-posts-another-batch-of-regulations-for-de-novo-devices Gears with regulatory words Tissium’s polymer solution set to transform nerve repair after FDA nod http://www.bioworld.com/articles/721141 Mon, 30 Jun 2025 12:00:00 -0400 https://www.bioworld.com/articles/721141-tissiums-polymer-solution-set-to-transform-nerve-repair-after-fda-nod tissium Tissium Coaptium Connect system. Credit: Tissium FDA releases another batch of regs for de novo decisions http://www.bioworld.com/articles/721119 Tue, 17 Jun 2025 12:00:00 -0400 https://www.bioworld.com/articles/721119-fda-releases-another-batch-of-regs-for-de-novo-decisions De novo key on keyboard J&J reports completion of first cases with Ottava robotic system holland.johnson@clarivate.com http://www.bioworld.com/articles/719131 Tue, 15 Apr 2025 12:00:00 -0400 https://www.bioworld.com/articles/719131-j-and-j-reports-completion-of-first-cases-with-ottava-robotic-system Da Vinci Xi robot - Intuitive Surgical The updated Ottava will feature four arms, like competitor Da Vinci Xi robot (pictured) from Intuitive Surgical. Credit: Intuitive Surgical Inc. FDA authorizes first home flu and COVID-19 combo test outside EUA holland.johnson@clarivate.com http://www.bioworld.com/articles/712921 Tue, 08 Oct 2024 12:00:00 -0400 https://www.bioworld.com/articles/712921-fda-authorizes-first-home-flu-and-covid-19-combo-test-outside-eua Healgen COVID-Flu OTC test kit Healgen Scientific's Rapid Check COVID-19/Flu A&B antigen test. Credit: Healgen Scientific LLC Digital products lead FDA’s de novo parade for September http://www.bioworld.com/articles/712017 Tue, 10 Sep 2024 12:00:00 -0400 https://www.bioworld.com/articles/712017-digital-products-lead-fdas-de-novo-parade-for-september De novo key on keyboard FDA still playing catch-up on de novo device classifications http://www.bioworld.com/articles/711940 Wed, 04 Sep 2024 12:00:00 -0400 https://www.bioworld.com/articles/711940-fda-still-playing-catch-up-on-de-novo-device-classifications FDA approval seal on blue glittering background Scopio wins FDA clearance for bone marrow aspirate application http://www.bioworld.com/articles/707454 Thu, 18 Apr 2024 12:00:00 -0400 https://www.bioworld.com/articles/707454-scopio-wins-fda-clearance-for-bone-marrow-aspirate-application Bone marrow illustration with doctor background Virtual Incision’s miniature robotic surgery device gets FDA nod http://www.bioworld.com/articles/705840 Mon, 26 Feb 2024 11:00:00 -0500 https://www.bioworld.com/articles/705840-virtual-incisions-miniature-robotic-surgery-device-gets-fda-nod MIRA Virtual Incision Virtual Incision Inc.’s MIRA system granted FDA de novo authorization for use in colectomy. Credit: Virtual Incision FDA blows good news Bluewind’s way with de novo approval for urgency incontinence device http://www.bioworld.com/articles/700077 Fri, 18 Aug 2023 12:00:00 -0400 https://www.bioworld.com/articles/700077-fda-blows-good-news-bluewinds-way-with-de-novo-approval-for-urgency-incontinence-device Bluewind Revi cuff Revi is activated with a lightweight, wearable cuff once or twice a day. Credit: Bluewind Medical Inc. FDA grants de novo to Masimo Opioid Halo http://www.bioworld.com/articles/695727 Mon, 03 Apr 2023 13:00:00 -0400 https://www.bioworld.com/articles/695727-fda-grants-de-novo-to-masimo-opioid-halo Masimo Opioid Halo finger monitor and mobile app Masimo’s Opioid Halo system. Medasense gets FDA nod for its nociception technology http://www.bioworld.com/articles/694531 Thu, 23 Feb 2023 13:00:00 -0500 https://www.bioworld.com/articles/694531-medasense-gets-fda-nod-for-its-nociception-technology PMD 200 platform in operating room Medasense Biometrics Ltd.’s PMD-200 with nociception level index helps clinicians personalize analgesia during surgery and reduce postoperative pain. FDA playing catch-up on regulations with a fistful of de novos http://www.bioworld.com/articles/693060 Fri, 06 Jan 2023 13:00:00 -0500 https://www.bioworld.com/articles/693060-fda-playing-catch-up-on-regulations-with-a-fistful-of-de-novos FDA website and logo Credit: Postmodern Studio - stock.adobe.com FDA provides five more device classifications via de novo petition http://www.bioworld.com/articles/516233 Fri, 18 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/516233-fda-provides-five-more-device-classifications-via-de-novo-petition Toy bulldozer moving FDA letter blocks FDA announces four new class II device designations http://www.bioworld.com/articles/515837 Mon, 07 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/515837-fda-announces-four-new-class-ii-device-designations FDA icons Class II designation finally effective for cerebrospinal fluid shunts http://www.bioworld.com/articles/514729 Fri, 31 Dec 2021 13:00:00 -0500 https://www.bioworld.com/articles/514729-class-ii-designation-finally-effective-for-cerebrospinal-fluid-shunts Hand holding FDA blocks FDA’s pressure on 510(k) process a factor in lawsuit between J&J, Auris http://www.bioworld.com/articles/514356 Thu, 16 Dec 2021 13:00:00 -0500 https://www.bioworld.com/articles/514356-fdas-pressure-on-510k-process-a-factor-in-lawsuit-between-j-and-j-auris FDA icons FDA slots five device types into class II, including for de novo granted in 2011 Federal Register. One of these de novo classifications, for conditioning tools for eating disorders, was the subject of a de novo petition filed in 2007 and granted in 2011.]]> http://www.bioworld.com/articles/513892 Wed, 01 Dec 2021 13:00:00 -0500 https://www.bioworld.com/articles/513892-fda-slots-five-device-types-into-class-ii-including-for-de-novo-granted-in-2011 Hand holding FDA blocks Hemolung respiratory assist system gets de novo nod http://www.bioworld.com/articles/513393 Mon, 15 Nov 2021 13:00:00 -0500 https://www.bioworld.com/articles/513393-hemolung-respiratory-assist-system-gets-de-novo-nod Doctor, patient using Hemolung Hemolung respiratory assist system. Credit: Alung Technologies Inc. Feops Heartguide granted FDA de novo authorization for LAAo planning http://www.bioworld.com/articles/512436 Fri, 15 Oct 2021 13:00:00 -0400 https://www.bioworld.com/articles/512436-feops-heartguide-granted-fda-de-novo-authorization-for-laao-planning Digital heart illustration FDA retains pre-inspection features in final rule for de novo petitions http://www.bioworld.com/articles/512085 Tue, 05 Oct 2021 13:00:00 -0400 https://www.bioworld.com/articles/512085-fda-retains-pre-inspection-features-in-final-rule-for-de-novo-petitions U.S. FDA headquarters Paige receives FDA de novo authorization for AI product for prostate cancer detection http://www.bioworld.com/articles/511688 Wed, 22 Sep 2021 13:00:00 -0400 https://www.bioworld.com/articles/511688-paige-receives-fda-de-novo-authorization-for-ai-product-for-prostate-cancer-detection Woman using Paige software on tablet Credit: Paige.ai Inc. Zimmer, Canary advance the cause of digital orthopedics with smart knee implant http://www.bioworld.com/articles/510913 Mon, 30 Aug 2021 13:00:00 -0400 https://www.bioworld.com/articles/510913-zimmer-canary-advance-the-cause-of-digital-orthopedics-with-smart-knee-implant Gold wireframe handshake De novo petitions not the same as patent protection, but some exclusivity available http://www.bioworld.com/articles/507622 Fri, 28 May 2021 13:00:00 -0400 https://www.bioworld.com/articles/507622-de-novo-petitions-not-the-same-as-patent-protection-but-some-exclusivity-available Patent law book and gavel Neurolutions wins de novo nod for stroke rehabilitation device http://www.bioworld.com/articles/506364 Mon, 26 Apr 2021 13:00:00 -0400 https://www.bioworld.com/articles/506364-neurolutions-wins-de-novo-nod-for-stroke-rehabilitation-device Patient wearing Ipsihand Ipsihand upper extremity rehabilitation system. Credit: Neurolutions Inc. Helius gets FDA nod for first neuromodulator for MS gait issues http://www.bioworld.com/articles/505369 Tue, 30 Mar 2021 13:00:00 -0400 https://www.bioworld.com/articles/505369-helius-gets-fda-nod-for-first-neuromodulator-for-ms-gait-issues Device components and in use Portable Neuromodulation Stimulator. Credit: Helius Medical Inc. Fifth Eye launches ML-based tool to predict hemodynamic instability http://www.bioworld.com/articles/504254 Tue, 02 Mar 2021 13:00:00 -0500 https://www.bioworld.com/articles/504254-fifth-eye-launches-ml-based-tool-to-predict-hemodynamic-instability Software screenshot Analytic for Hemodynamic Instability. Credit: Fifth Eye Inc. Study underscores effectiveness of Caption Health's AI-guided ultrasound software http://www.bioworld.com/articles/503838 Fri, 19 Feb 2021 13:00:00 -0500 https://www.bioworld.com/articles/503838-study-underscores-effectiveness-of-caption-healths-ai-guided-ultrasound-software Product image Caption Guidance. Credit: Caption Health Inc. FDA gives nod to first-ever daytime treatment for sleep apnea http://www.bioworld.com/articles/503355 Mon, 08 Feb 2021 13:00:00 -0500 https://www.bioworld.com/articles/503355-fda-gives-nod-to-first-ever-daytime-treatment-for-sleep-apnea Mobile app and device ExciteOSA offers first daytime treatment of obstructive sleep apnea. Credit: Signifier Medical Technologies LLC.