MedTech News
Dec 01, 2022
AnchorDx’s UriFind Bladder Cancer Assay in the US; UroMems Initiates Smart Implant to Treat Stress Urinary Incontinence; FDA 510(k) Clearance to NeuroLogica’s BodyTom 64; CE-IVD Mark Approval to SeekInCure’s Recurrence Monitoring Kit Gets; Ypsomed and CamDiab’s Automated Insulin Dosing System; Boston Scientific to Acquire Apollo Endosurgery
AnchorDx Clinical Trial Enrols First Patient for its UriFind® Bladder Cancer Assay in the US On November 23, 2022, AnchorDx, announced the first patient enrollment for its clinical trials of the UriFind® bladder cancer assay in the United States. The UriFind® bladder cancer assay clinical trial in the U...
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Nov 24, 2022
Mainstay Medical’s ReActiv8-C Study; Swing Therapeutics Announced Results from Studies of Stanza; FDA Approves Empatica’s Health Monitoring Platform; FDA Clearance to Persona OsseoTi Keel Tibia System; ClariPi Joins Siemens Healthineers Digital Marketplace; Sony Launches Cloud-based Solution for Flow Cytometry Data Analysis
Mainstay Medical Published Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study On November 22, 2022, Mainstay Medical, a medical devices company, announced that the data from the ReActiv8®-C study, a single-centre, real-world study with a one-year clinical follow-up of selected patients, is publ...
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Nov 17, 2022
Medtronic Launches Infusion Set for Insulin Pumps; Penumbra’s Virtual Reality-Based Rehabilitation System; FDA Approval to Genesis’s Chocolate Touch® Drug-coated Balloon PTA Catheter; FDA Nod to AEYE’s AI-based Autonomous Screening; Alpheus Medical Treats First High-Grade Glioma Brain Cancer Patient with its Proprietary Platform; Karidum’s Next Generation Globe® Pulsed Field System
Medtronic Launches World's First and Only Infusion Set for Insulin Pumps that Doubles Wear Time up to 7 days in the US On November 15, 2022, Medtronic plc, a global leader in healthcare technology, announced the US launch of the Medtronic Extended infusion set, the first and only infusion set labeled for up to ...
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Nov 10, 2022
QuantuMDx & Menarini’s Agreement; TruClear System Launched by Medtronic in India; FDA 510(k) Clearance for TriVerse Primary Knee Replacement System; FDA Clearance to ProciseDx’s Reactive Protein (CRP) Assay and ProciseDx Instrument; Evolution Optiks’s Enrollment of LFR-260 Phoropter in US; Kardium First-in-Human Clinical Study of the New Globe Pulsed Field System
QuantuMDx and Menarini Announced an Agreement for the Distribution of the Q-POCTM Platform On November 2, 2022, QuantuMDx Group Limited, a UK-based developer of transformational Point-of-Need molecular diagnostics, and A.Menarini Diagnostics S.r.I. (Menarini), announced an exclusive distribution agreement for Qu...
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Oct 20, 2022
Biosense Webster’s HELIOSTAR Radiofrequency Balloon Ablation Catheter; Philips’s ClarifEye Augmented Reality Surgical Navigation Solution; NeuroLogica’s Elite Mobile Computed Tomography Devices; Medtronic’s Natural Conduction System for Heart; Pfizer & BioNTech’s Omicron BA.4/BA.5-Adapted Bivalent Booster Trial; Castle Biosciences’s TissueCypher® Barrett’s Esophagus Test
HELIOSTAR™ Radiofrequency Balloon Ablation Catheter Launched by Biosense Webster in Europe On October 12, 2022, Biosense Webster, a part of Johnson & Johnson Medical technology, announced the launch of HELIOSTAR™ Balloon Ablation Catheter, the first radiofrequency balloon ablation catheter in E...
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Oct 13, 2022
Neuspera Medical’s Nuvella System; Abbott Presented the Data for FreeStyle Libre 2 System; ZEISS Receives FDA 510(k) Clearance for MTLawton; FDA 510(k) Clearance for the GHOST 3D-Printed Titanium Spacer System; Thermo Fisher Scientific Launched CE-IVD Marked TaqPath Enteric Bacterial Select Panel; BIOCORP and Merck Announced New Partnership
Neuspera Medical Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its Sans-Uui Ide Clinical Trial On October 10, 2022, Neuspera Medical, a medical device company involved in the development of implantable devices for patients suffering from chronic illnesses, announced that...
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Sep 29, 2022
Asahi Intecc Partners with Penumbra; Prosoma and EVERSANA Announce Commercialisation Partnership; Zynex Starts Enrollment in the Blood Loss Detection Clinical Trial; Reva Initiates Enrollment in the MOTIV IDE Clinical Trial; FDA Clearance to QT Imaging to Calculate Fibroglandular Volume of the Breast; FDA 510k Clearance to iMediSync’s EEG scanner ‘iSyncWave’
Asahi Intecc partners with Penumbra to roll out Indigo System in Japan On September 22, 2022, Asahi Intecc, a Surgical and medical instrument manufacturing company, partnered with Penumbra, a medical device company headquartered in Alameda, California, to roll out Indigo System in Japan. After getting regulat...
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Sep 22, 2022
Smith+Nephew’s OR3O Dual Mobility System; Medtronic Launches the Evolut FX Next-Gen TAVR System; FDA Approves Edwards’s Pascal Precision Transcatheter Valve Repair System; FDA Clearance to Zimmer Biomet’s Identity Shoulder System; Otsuka Announces Results of RADIANCE II Trial; Smith+Nephew Announces Data for its REGENETEN™ Bioinductive Implant
OR3O™ Dual Mobility System launched by Smith+Nephew in Japan for use in primary and revision hip arthroplasty On September 20, 2022, Smith+Nephew, a leading global portfolio medical technology business, announced the launch of OR3O Dual Mobility System for use in primary and revision hip arthro...
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Sep 15, 2022
Aerin Medical’s RhinAer Stylus; CE Mark for Haemonetics’s VASCADE Vascular Closure Device; J&J Vision Launches ACUVUE OASYS MAX 1-Day; Olympus Launches VISERA ELITE III Surgical Visualization Platform; GlucoRx’s Non-Invasive Glucose Monitoring Platform; Medtronic-BioIntelliSense’s Partnership; Corindus’s CorPath GRX Neurovascular System Trial; GE & Lantheus [18F]flurpiridaz PET Radiotracer Trial; Pulmonx’s AeriSeal System Trial; AtriAN’s Second Study on Cardioneuroablation
Johnson & Johnson Vision Launches New Contact Lens Innovation ACUVUE® OASYS MAX 1-Day for Meeting the Needs of Digitally Intense Lifestyles On September 12, 2022, Johnson & Johnson Vision, a part of Johnson & Johnson and a global leader in the eyecare market, had announced the launch of its newest in...
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Sep 08, 2022
eCential Robotics’s Surgical Robotic Platform for Spine Surgery; Baxter Gets 510(k) Clearance for Syringe Pump; Medical Microinstruments’s NanoWrist Instruments; Magnus’ SAINT Neuromodulation System; Henry Schein Acquires Midway Dental Supply
eCential Robotics Receives FDA Clearance for its Surgical Robotic Platform for Spine Surgery The FDA has approved a robotic spinal surgery platform designed to assist human surgeons by automating several steps of spinal procedures. The platform, developed by eCential Robotics, combines intraoperative 2D and 3D i...
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