IDE https://www.bioworld.com/rss en-us MMI gets IDE for robotic microsurgical study in Alzheimer’s holland.johnson@clarivate.com http://www.bioworld.com/articles/725948 Mon, 10 Nov 2025 11:00:00 -0500 https://www.bioworld.com/articles/725948-mmi-gets-ide-for-robotic-microsurgical-study-in-alzheimers Symani system The Symani surgical system allows surgeons to replicate hand movements at a micro level. Credit: Symani CG Bio, Nexgel developing long-acting drug delivery system http://www.bioworld.com/articles/725510 Tue, 04 Nov 2025 11:00:00 -0500 https://www.bioworld.com/articles/725510-cg-bio-nexgel-developing-long-acting-drug-delivery-system Deal illustration Onward Medical receives FDA IDE for BP study with ARC-IM system http://www.bioworld.com/articles/723176 Tue, 19 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/723176-onward-medical-receives-fda-ide-for-bp-study-with-arc-im-system Onward Arc IM system Onward Arc IM system. Credit: Onward Medical Newronika gets IDE from the FDA for adaptive DBS trial http://www.bioworld.com/articles/716907 Tue, 11 Feb 2025 11:00:00 -0500 https://www.bioworld.com/articles/716907-newronika-gets-ide-from-the-fda-for-adaptive-dbs-trial DBS for stroke In the EDEN trial, a single DBS lead was implanted into the cerebellum and connected to a pacemaker-like device in the upper back. Credit: Courtesy of Cleveland Clinic Deepqure gets FDA IDE nod for renal denervation device trial http://www.bioworld.com/articles/709248 Tue, 11 Jun 2024 12:00:00 -0400 https://www.bioworld.com/articles/709248-deepqure-gets-fda-ide-nod-for-renal-denervation-device-trial DeepQure Deepqure. Credit: Deepqure FDA advances AI-enhanced tech for prostate diagnosis and treatment http://www.bioworld.com/articles/521460 Tue, 09 Aug 2022 13:00:00 -0400 https://www.bioworld.com/articles/521460-fda-advances-ai-enhanced-tech-for-prostate-diagnosis-and-treatment Man undergoing MRI scan for prostate cancer diagnosis Cardialen wins FDA IDE approval for low-energy pulse therapy http://www.bioworld.com/articles/513522 Thu, 18 Nov 2021 13:00:00 -0500 https://www.bioworld.com/articles/513522-cardialen-wins-fda-ide-approval-for-low-energy-pulse-therapy Cardiovascular illustration FDA draft for investigator safety reporting offers little detail on combo product studies http://www.bioworld.com/articles/511905 Wed, 29 Sep 2021 13:00:00 -0400 https://www.bioworld.com/articles/511905-fda-draft-for-investigator-safety-reporting-offers-little-detail-on-combo-product-studies Hand holding FDA blocks Livanova gets FDA nod for pivotal sleep apnea trial http://www.bioworld.com/articles/508313 Thu, 17 Jun 2021 11:01:00 -0400 https://www.bioworld.com/articles/508313-livanova-gets-fda-nod-for-pivotal-sleep-apnea-trial Aura6000 device, illustration showing placement Aura6000 sleep apnea device. Credit: Livanova plc Acutus rings up regulatory approvals http://www.bioworld.com/articles/508259 Tue, 15 Jun 2021 13:00:00 -0400 https://www.bioworld.com/articles/508259-acutus-rings-up-regulatory-approvals Acqmap console image Acqmap imaging and mapping system. Credit: Acutus Medical Inc. Neurescue’s aortic occlusion device gets FDA nod for hemorrhage and IDE for cardiac arrest http://www.bioworld.com/articles/508088 Thu, 10 Jun 2021 13:00:00 -0400 https://www.bioworld.com/articles/508088-neurescues-aortic-occlusion-device-gets-fda-nod-for-hemorrhage-and-ide-for-cardiac-arrest Neurescue device image Intelligent balloon catheter for aortic occlusion. Credit: Neurescue Atheart Medical begins IDE trial for septal closure device http://www.bioworld.com/articles/506261 Thu, 22 Apr 2021 13:00:00 -0400 https://www.bioworld.com/articles/506261-atheart-medical-begins-ide-trial-for-septal-closure-device Resept ASD occluder image Resept ASD occluder. Credit: Atheart Medical Inc. FDA OKs IDE trial of Agnovos Healthcare’s breakthrough spine device http://www.bioworld.com/articles/506090 Mon, 19 Apr 2021 13:00:00 -0400 https://www.bioworld.com/articles/506090-fda-oks-ide-trial-of-agnovos-healthcares-breakthrough-spine-device AGN1 LEOP SV kit image The AGN1 LEOP SV kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation. Credit: Agnovos Healthcare LLC Hancock Jaffe prepares for Venovalve pivotal trial http://www.bioworld.com/articles/505935 Wed, 14 Apr 2021 13:00:00 -0400 https://www.bioworld.com/articles/505935-hancock-jaffe-prepares-for-venovalve-pivotal-trial Venovalve product rendering Venovalve. Credit: Hancock Jaffe Laboratories Inc. FDA gives nod to Virtual Incision to start study of MIRA Platform http://www.bioworld.com/articles/499483 Tue, 27 Oct 2020 13:00:00 -0400 https://www.bioworld.com/articles/499483-fda-gives-nod-to-virtual-incision-to-start-study-of-mira-platform Product image Miniaturized in vivo robotic assistant (MIRA) Platform. Credit: Virtual Incision Corp. Positive results seen with Shockwave IVL in pivotal IDE study http://www.bioworld.com/articles/499077 Fri, 16 Oct 2020 13:00:00 -0400 https://www.bioworld.com/articles/499077-positive-results-seen-with-shockwave-ivl-in-pivotal-ide-study Illustration of calcified artery, heart Carag secures IDE approval for Bioresorbable Septal Occluder BioWorld.]]> http://www.bioworld.com/articles/436241 Thu, 02 Jul 2020 13:00:00 -0400 https://www.bioworld.com/articles/436241-carag-secures-ide-approval-for-bioresorbable-septal-occluder Product image Carag Bioresorbable Septal Occluder. Credit: Carag AG Ancora Heart gets FDA nod for Accucinch pivotal trial http://www.bioworld.com/articles/436161 Tue, 30 Jun 2020 13:00:00 -0400 https://www.bioworld.com/articles/436161-ancora-heart-gets-fda-nod-for-accucinch-pivotal-trial Accucinch in heart model Accucinch ventricular restoration system. Credit: Ancora Heart Inc. FDA greenlights Balt’s STEM trial for subdural hematoma http://www.bioworld.com/articles/435184 Mon, 18 May 2020 13:00:00 -0400 https://www.bioworld.com/articles/435184-fda-greenlights-balts-stem-trial-for-subdural-hematoma CT scan of brain showing subdural hematoma CT scan of brain showing subdural hematoma. Setpoint Medical's platform receives IDE approval BioWorld.]]> http://www.bioworld.com/articles/435018 Mon, 11 May 2020 13:00:00 -0400 https://www.bioworld.com/articles/435018-setpoint-medicals-platform-receives-ide-approval Neural network Beyond Air seeks IDE for nitric oxide treatment for COVID-19 http://www.bioworld.com/articles/433778 Tue, 17 Mar 2020 12:00:00 -0400 https://www.bioworld.com/articles/433778-beyond-air-seeks-ide-for-nitric-oxide-treatment-for-covid-19 3-17-Beyond-Air-Lung-BRO.png Lungfit Bro. Credit: Beyond Air Inc. Alydia Health wraps up enrollment in pivotal study of device postpartum hemorrhage http://www.bioworld.com/articles/433090 Fri, 14 Feb 2020 12:00:00 -0500 https://www.bioworld.com/articles/433090-alydia-health-wraps-up-enrollment-in-pivotal-study-of-device-postpartum-hemorrhage Woman giving birth GI Dynamics enrolls first patient in pivotal Endobarrier trial http://www.bioworld.com/articles/432688 Tue, 28 Jan 2020 12:00:00 -0500 https://www.bioworld.com/articles/432688-gi-dynamics-enrolls-first-patient-in-pivotal-endobarrier-trial 1-28-GI-dynamics-endobarrier-hero.png Illustration of Endobarrier placement. Credit: GI Dynamics Inc. FDA greenlights Ra Medical’s DABRA atherectomy trial http://www.bioworld.com/articles/432567 Wed, 22 Jan 2020 12:00:00 -0500 https://www.bioworld.com/articles/432567-fda-greenlights-ra-medicals-dabra-atherectomy-trial Green traffic light PGDx receives IDE approval to support Merck’s precision oncology trial http://www.bioworld.com/articles/431553 Wed, 04 Dec 2019 12:00:00 -0500 https://www.bioworld.com/articles/431553-pgdx-receives-ide-approval-to-support-mercks-precision-oncology-trial PGDx-elio12-4.png Pq Bypass gets FDA OK to launch Torus SFA stent graft pivotal trial http://www.bioworld.com/articles/430102 Wed, 09 Oct 2019 00:00:00 -0400 https://www.bioworld.com/articles/430102-pq-bypass-gets-fda-ok-to-launch-torus-sfa-stent-graft-pivotal-trial FDA grants IDE approval for pivotal study of Avita Medical's Recell system http://www.bioworld.com/articles/430199 Wed, 18 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/430199-fda-grants-ide-approval-for-pivotal-study-of-avita-medicals-recell-system