FDA Archives - TMG Pulse

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Clinical Trial FDA Neuro Neurovascular

Sonorous Neurovascular Receives FDA IDE Approval for First U.S. Pivotal Trial of a Venous Sinus Stent to Treat Pulsatile Tinnitus

LAKE FOREST, Calif., Oct. 7, 2026 /PRNewswire/ — Sonorous Neurovascular, a clinical-stage medical device company […]

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Commercial Launch FDA Neuro Surgery

Saluda Medical Expands Access to First and Only FDA-Approved Closed-Loop Surgical Paddle Lead with Full US Commercial Release of CAP24™

BLOOMINGTON, Minn., Oct. 6, 2026 /PRNewswire/ — Saluda Medical, Inc. (ASX: SLD, “Saluda” or the […]

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Cardiovasular Clinical Trial FDA

Medtronic snags breakthrough designation for below-the-knee drug-coated balloon

Medtronic (NYSE:MDT) has secured a breakthrough designation from the FDA for a version of its […]

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Clinical Trial FDA Pediatrics

UTR Therapeutics Inc. Announces U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14

NEW YORK, Sept. 29, 2026 /PRNewswire/ — UTR Therapeutics Inc., a biotech company with clinical […]

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Clinical Trial FDA

Adicet Bio CAR-T sparks lupus remissions in early trial as ‘new era’ of autoimmune treatment approaches

As the race to harness CAR-T cells for autoimmune diseases hits a rough patch, a […]

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Commercial Launch FDA FDA Cleared

Marani Health Receives FDA Clearance for M•care System, Clearing the Path Toward Commercial Launch

MINNEAPOLIS, Sept. 24, 2026 /PRNewswire/ — Maternal health technology company Marani Health today announced that […]

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Dentistry FDA Wound Care

FDA clears at-home dental dressing for non-surgical periodontal procedures

The FDA cleared a personalized wound dressing that users can apply themselves at home following […]

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FDA Respiratory

Applied Photonix Launches ViroZap®, the First FDA-Cleared Medical Device for In-Duct Air Disinfection

TAMPA, Fla., Sept. 15, 2026 /PRNewswire/ — Applied Photonix today announced the commercial launch of ViroZap®, the first FDA-cleared, […]

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Commercial Launch FDA

Anatool Launches to Improve Recognition and Treatment of Anaphylaxis

CINCINNATI, Sept. 9, 2026 /PRNewswire/ — A new clinical support tool called Anatool aims to provide point-of-care […]

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FDA Imaging Radiology

Rongtao Medical Publishes Legacy Ultrasound Cybersecurity Framework Built on FDA, CISA and OEM Evidence

GUANGZHOU, China, Aug. 27, 2026 /PRNewswire/ — Guangzhou Rongtao Medical Technology Co., Ltd. (“Rongtao Medical”) today published an evidence-based […]

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Diagnostics FDA Neuro

Labcorp to Offer First FDA-Cleared Blood Test to Detect Alzheimer’s Disease Pathology in Both Primary and Specialty Care Settings

BURLINGTON, N.C., Aug. 24, 2026 /PRNewswire/ — Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced […]

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FDA Robotics Vascular

FDA authorizes first-of-its-kind autonomous robotic blood draw device

The FDA granted de novo classification to a standalone robotic device that can draw blood […]

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AI FDA

FDA considers ‘competency-based’ evaluations for GenAI-enabled medical devices

The FDA published a discussion paper this week seeking feedback on its considerations for regulations […]

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FDA FDA Approved Vascular

FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System

MINNEAPOLIS, Aug. 11, 2026 /PRNewswire/ — FastWave Medical, which is developing next-generation intravascular lithotripsy (IVL) technology, has received FDA approval of […]

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FDA Surgery

Amend Surgical Advances NanoFUSE® Bioactive Plug Development Through Exclusive Licensing Agreement with MLM Biologics

ALACHUA, Fla., Aug. 10, 2026 /PRNewswire/ — Amend Surgical, a regenerative biomaterials company focused on developing innovative […]

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Diagnostics FDA Point-of-Care Testing

Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

SALT LAKE CITY, Aug. 6, 2026 /PRNewswire/ — Co-Diagnostics, Inc. (Nasdaq: CODX) (“Co-Dx” or “the Company”), a molecular diagnostics company with […]

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Cardiology FDA PFA

Adagio treats first patient with next-gen low-temp ablation system

Adagio Medical (Nasdaq:ADGM) today announced the successful treatment of the first patient with its next-generation vCLAS […]

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Cardiology Clinical Study FDA

VDyne enrolls first patient in IDE study of tricuspid valve

VDyne announced today that it enrolled the first patient in the pivotal FDA investigational device exemption […]

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Clinical Study FDA Ophthalmology

Glaukos completes enrollment in Preserflo MicroShunt study

Glaukos (NYSE:GKOS) announced today that it completed enrollment in a pivotal study evaluating its Preserflo MicroShunt […]

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FDA Gastroenterology Surgery

Johnson & Johnson wins FDA nod for Ottava surgical robot

Johnson & Johnson (NYSE:JNJ) announced today that it received FDA de novo authorization for its Ottava […]

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FDA Surgery Women's Health

Claria Medical earns FDA nod for tissue containment, removal device for hysterectomy

Claria Medical announced today that it received FDA de novo authorization for its Claria system […]

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Clinical Study Clinical Trial FDA Vascular

xDot Medical can begin FDA IDE study of vascular closure device

xDot Medical announced today that it received FDA investigational device exemption (IDE) approval for its […]

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Clinical Trial Diagnostics FDA

SkylineDx’s Merlin CP-GEP Granted FDA Breakthrough Device Designation, Building on Exclusive NCCN Recognition in Melanoma Care

ROTTERDAM, Netherlands and SAN DIEGO, July 1, 2026 /PRNewswire/ — SkylineDx, innovative diagnostics company specializing in the […]

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FDA Neuro Uncategorized

Aurenar gets FDA breakthrough nod for noninvasive neuromod tech

Aurenar announced today that it received FDA breakthrough device designation for its V-Link noninvasive neuromodulation […]

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Cardiology Cardiovasular Clinical Study FDA

Johnson & Johnson begins carotid IVL study enrollment

Johnson & Johnson (NYSE:JNJ) today announced the initiation of its SKYWARD clinical program for a new Shockwave IVL […]

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FDA Imaging Radiology Strategic Partnership

Pulsenmore Announces Strategic Partnership with Ouma Health to Expand Access to Remote Prenatal Care Across the United States

RAMAT GAN, Israel, June 24, 2026 /PRNewswire/ — Pulsenmore Ltd. (NASDAQ: PLSM) (TASE: PLSM), a pioneer in home ultrasound technology, […]

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Clinical Study FDA Oncology

AngioDynamics wins FDA IDE for feasibility study of NanoKnife in BPH

AngioDynamics (Nasdaq:ANGO) announced today that it received FDA investigational device exemption (IDE) to initiate the RELIEF […]

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FDA Imaging Spine Surgery

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasive, Image-Guided Lumbar Disc Treatment.

TORONTO, June 9, 2026 /PRNewswire/ – SpinaFX Medical, a clinical-stage medical device company specializing in minimally invasive, […]

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Diagnostics FDA

Zepto Life Technology Receives FDA Breakthrough Device Designation for Targeted Liquid Biopsy Test for Invasive Mold Infections

ST. PAUL, Minn., June 3, 2026 /PRNewswire/ — Zepto Life Technology announced today that the U.S. Food […]

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Digital Health FDA Neuro

Neurovalens earns FDA nod for neuromod for PTSD

Neurovalens announced today that it received FDA de novo approval for Modius Spero, a post-traumatic stress […]

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Cardiology FDA PFA

Adagio submits ventricular ablation system to FDA

Adagio Medical (Nasdaq:ADGM) announced today that it submitted its premarket approval (PMA) application to the FDA […]

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FDA Orthopedic Surgical Robotics

Zimmer Biomet gets expanded FDA nod for Rosa robotic shoulder system

Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for an advanced version of […]

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Diagnostics FDA MedTech

Natera wins FDA approval for companion diagnostic

Dive Brief: Dive Insight: Researchers have linked the presence of circulating tumor DNA, or ctDNA, […]

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Clinical Trial FDA Implantables Urology

Zenflow findings back BPH treatment device

Zenflow recently shared data from its BREEZE pivotal clinical trial supporting the use of its Spring […]

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Aquisition FDA Wearables

Resmed enters merger agreement to acquire Noctrix Health for $340 million

Resmed (NYSE: RMD) has entered into a definitive merger agreement to acquire Noctrix Health for $340 […]

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FDA Surgical Robotics Women's Health

CMR Surgical Submits 510(k) Application to U.S. FDA to Expand Versius Plus™ into Gynecology

CAMBRIDGE, UK, April 29, 2026 — CMR Surgical, a global medical technology business, today announced that […]

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FDA FDA Cleared Orthopedic

Pixee wins FDA nod for next-gen AR knee surgery tech

Pixee Medical announced today that it received FDA 510(k) clearance for its Knee+ NexSight augmented reality […]

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Cardiovasular Clinical Trial FDA

Medtronic wins FDA breakthrough nod for Sphere-9 catheter, reports new clinical milestones for Affera

Medtronic (NYSE:MDT) today announced new milestones for its Affera family of technologies, including a breakthrough device […]

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Cardiology Cardiovasular Clinical Trial FDA

Adagio ventricular ablation tech performs well in clinical trial

Adagio Medical (Nasdaq:ADGM) today announced new six-month results from its FULCRUM-VT clinical trial evaluating its ablation […]

Topic: FDA

Sonorous Neurovascular Receives FDA IDE Approval for First U.S. Pivotal Trial of a Venous Sinus Stent to Treat Pulsatile Tinnitus

Saluda Medical Expands Access to First and Only FDA-Approved Closed-Loop Surgical Paddle Lead with Full US Commercial Release of CAP24™

Medtronic snags breakthrough designation for below-the-knee drug-coated balloon

UTR Therapeutics Inc. Announces U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14

Adicet Bio CAR-T sparks lupus remissions in early trial as ‘new era’ of autoimmune treatment approaches

Marani Health Receives FDA Clearance for M•care System, Clearing the Path Toward Commercial Launch

FDA clears at-home dental dressing for non-surgical periodontal procedures

Applied Photonix Launches ViroZap®, the First FDA-Cleared Medical Device for In-Duct Air Disinfection

Anatool Launches to Improve Recognition and Treatment of Anaphylaxis

Rongtao Medical Publishes Legacy Ultrasound Cybersecurity Framework Built on FDA, CISA and OEM Evidence

Labcorp to Offer First FDA-Cleared Blood Test to Detect Alzheimer’s Disease Pathology in Both Primary and Specialty Care Settings

FDA authorizes first-of-its-kind autonomous robotic blood draw device

FDA considers ‘competency-based’ evaluations for GenAI-enabled medical devices

FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System

Amend Surgical Advances NanoFUSE® Bioactive Plug Development Through Exclusive Licensing Agreement with MLM Biologics

Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Adagio treats first patient with next-gen low-temp ablation system

VDyne enrolls first patient in IDE study of tricuspid valve

Glaukos completes enrollment in Preserflo MicroShunt study

Johnson & Johnson wins FDA nod for Ottava surgical robot

Claria Medical earns FDA nod for tissue containment, removal device for hysterectomy

xDot Medical can begin FDA IDE study of vascular closure device

SkylineDx’s Merlin CP-GEP Granted FDA Breakthrough Device Designation, Building on Exclusive NCCN Recognition in Melanoma Care

Aurenar gets FDA breakthrough nod for noninvasive neuromod tech

Johnson & Johnson begins carotid IVL study enrollment

Pulsenmore Announces Strategic Partnership with Ouma Health to Expand Access to Remote Prenatal Care Across the United States

AngioDynamics wins FDA IDE for feasibility study of NanoKnife in BPH

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasive, Image-Guided Lumbar Disc Treatment.

Zepto Life Technology Receives FDA Breakthrough Device Designation for Targeted Liquid Biopsy Test for Invasive Mold Infections

Neurovalens earns FDA nod for neuromod for PTSD

Adagio submits ventricular ablation system to FDA

Zimmer Biomet gets expanded FDA nod for Rosa robotic shoulder system

Natera wins FDA approval for companion diagnostic

Zenflow findings back BPH treatment device

Resmed enters merger agreement to acquire Noctrix Health for $340 million

CMR Surgical Submits 510(k) Application to U.S. FDA to Expand Versius Plus™ into Gynecology

Pixee wins FDA nod for next-gen AR knee surgery tech

Medtronic wins FDA breakthrough nod for Sphere-9 catheter, reports new clinical milestones for Affera

Adagio ventricular ablation tech performs well in clinical trial