medical device
Nov 21, 2024
Cartessa Aesthetics teams with Classys for Everesse; LogicMark unveils Freedom Alert Max; GE HealthCare clears SIGNA MAGNUS MRI; OMRON’s BP monitor with AI-powered AFib detection gets FDA approval; Boston Scientific’s WATCHMAN FLX™ cuts bleeding risk; Encora Therapeutics wraps ULTRE trial for tremor device
Cartessa Aesthetics Partnered With Classys, Inc. to Bring Everesse to the US Market On November 14, 2024, Cartessa Aesthetics, a leading North American aesthetic medical device company, collaborated with Classys, Inc., a prominent global aesthetics firm based in South Korea, to introduce EVERESSE by Volnew...
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Nov 14, 2024
FDA Grants Approval to Caris Life Sciences for MI Cancer Seek; Johnson & Johnson MedTech Secures FDA IDE Approval for OTTAVA; Organogenesis Shares Positive Interim Data from Second Phase 3 Study of ReNu; LivaNova’s OSPREY Trial Achieves Key Safety and Efficacy Milestones; Hyperfine Launches Advanced Portable MR Brain Imaging Swoop® System Across Europe; Nihon Kohden Strengthens Neurological Solutions Through Ad-Tech Medical Instrument Corporation Acquisition
Caris Life Sciences Received FDA Approval for MI Cancer Seek™ as a Companion Diagnostic (CDx) Test On November 6, 2024, Caris Life Sciences, a leading next-generation AI TechBio company and precision medicine pioneer, announced that the U.S. Food and Drug Administration (FDA) approved MI Cancer Seek™ for u...
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Oct 31, 2024
Medtronic Secures FDA Green Light for Affera™ Mapping and Ablation System Alongside Sphere-9™ Catheter; Precision Optics Gets FDA 510(k) Clearance; Abbott Launches New Clinical Trial Aimed at Enhancing Care for Advanced Heart Failure Patients; Fresenius Medical Care’s Study Confirms Efficacy of New Anemia Therapy Software in Enhancing Outcomes for Hemodialysis Patients; Inspira™ Announces New Distribution Center to Support INSPIRA™ ART100’s U.S. Introduction; WellSky Expands Home Care Offerings with Acquisition of Bonafide
Medtronic Received FDA Approval for Affera™ Mapping and Ablation System and Sphere-9™ Catheter, Pioneering Advances in Arrhythmia Treatment On October 24, 2024, Medtronic plc, a global leader in healthcare technology, announced the United States Food and Drug Administration (FDA) approval of its Affera™ Ma...
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Oct 24, 2024
iRhythm’s Zio® AT Device Improvements Receive FDA Clearance; Epitel Adds REMI AI Device to Portfolio with Fourth FDA 510(k); SeaStar Medical Advances Acute Kidney Injury Trial, Approaches Interim Analysis; Endospan Completes Primary Enrollment for TRIOMPHE Study of NEXUS® Stent Graft; Boston Scientific Enhances FARAPULSE™ PFA with New Cardiac Mapping Technology; GE HealthCare Debuts CareIntellect to Support Oncologists with AI-Enhanced Patient Insights
iRhythm Technologies Received FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device On October 21, 2024, iRhythm Technologies, Inc., a leading digital healthcare company specializing in solutions to detect, predict, and prevent disease, announced that the U.S. Food and Drug Administ...
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Oct 17, 2024
Roche Receives FDA Approval for Itovebi; FDA Approves Bausch + Lomb’s Envista® Envy™; Microbot Medical Successfully Completes Pivotal Human Clinical Trial and Accelerates Go-to-Market Strategy for LIBERTY® Launch; Positive FDA Guidance on Phase III Trial of 64Cu-SAR-Bispsma for Recurrent Prostate Cancer; ELEHEAR Launches Hearing Aids at Just $399; Abbott Advances Pulsed Field Ablation Studies and Launches New Technology for Cardiac Mapping
FDA Approved Roche’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation On October 11, 2024, Roche announced that the United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibran...
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Oct 10, 2024
Johnson & Johnson Acquires V-Wave; CalmiGo Launches Anxiety-Management Platform CalmiGo Plus; Vy Spine Secures FDA Clearance for 3D-Printed Lumbar IBF; InspireMD Receives IDE Approval for CGuard Stent Study; GE Healthcare Reveals Phase I MRI Contrast Results; Medinol Completes First Human Implantation of Drug-Eluting Stent
Johnson & Johnson Completed Acquisition of V-Wave On Oct 09, 2024, Johnson & Johnson announced that it successfully completed the acquisition of V-Wave Ltd., a privately-held company dedicated to developing innovative treatments for heart failure patients. V-Wave will now operate under Johnson & John...
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Oct 03, 2024
Establishment Labs Gains FDA Approval for Motiva Implants; Surmodics Receives 510(k) Clearance for Pounce™ XL Thrombectomy System; Synergy Spine Solutions Completes Patient Enrollment in Synergy Disc® 2-Level IDE Clinical Trial; Medtronic Reports Strong Lesion Durability Data for PulseSelect™ Ablation System and Expands AiBLE™ Spine Surgery Ecosystem with Siemens Healthineers Partnership; Globus Medical Launches New Orthopedic Trauma Solutions
Establishment Labs Received U.S. FDA Approval for Motiva Implants On September 26, 2024, Establishment Labs Holdings Inc., a global medical technology company focused on enhancing women’s health and wellness, particularly in breast aesthetics and reconstruction, announced that it received approval from the U.S. ...
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Sep 26, 2024
Vivos Therapeutics Receives FDA 510(k) Clearance for Pediatric Sleep Apnea; Nevro Launches AI-Driven Spinal Cord Stimulation; Jupiter Endovascular Treated First Patients in Pulmonary Embolectomy System Study; Toro Neurovascular Advances Stroke Treatment with SuperBore Aspiration Catheter; GE HealthCare Introduces Venue Ultrasound Solutions; Linear Health Expands Orchid Safety Valve Indications
Vivos Therapeutics Received Groundbreaking FDA 510(k) Clearance to Treat Moderate to Severe Pediatric Sleep Apnea and Snoring On September 18, 2024, Vivos Therapeutics, Inc., a premier medical device and technology firm focused on innovative treatments for sleep-related breathing disorders (SRBDs), including obs...
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Sep 19, 2024
Boston Scientific INGEVITY™ gets Expanded Indication and acquires Silk Road Medical; FDA Approves Philips’ LumiGuide Guidewire; Microbot Completes LIBERTY Trial Enrollment; Innovent Presents Data at ESMO 2024; Argon Medical Launches CLEANER Vac™ System
Boston Scientific Received FDA Approval For The Expanded Indication of INGEVITY™+ Pacing Leads, Allowing For Conduction System Pacing in The Left Bundle Branch Area On September 17, 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval to expand the indication for th...
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Sep 12, 2024
SpectraWAVE raised $50M; Rockwell Medical signed dialysis deal; Modular Medical got FDA nod for Modd1 pump; iRhythm’s Zio approved in Japan; Autonomix trial showed 83% pain reduction; Insulin Efsitora Alfa improved A1C.
Modular Medical Announced the FDA Clearance for the Modd1 Insulin Pump On September 5, 2024, Modular Medical, Inc., an insulin delivery system technology company, announced that it received the U.S. Food and Drug Administration (FDA) clearance to market and sell its MODD1 pump in the United States. With it...
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