Ablation Devices
Jan 29, 2026
Seno Medical Secures EU MDR CE Mark for Next-Generation Imagio® Imaging System; Spine Innovation Announces FDA 510(k) Clearance of LOGIC™ Titanium Expandable Interbody System; Laborie Adds JADA® System to Obstetrics Portfolio for Rapid PPH Control; Olympus Introduces SecureFlex™ Single-Use Fine Needle Biopsy Device in the U.S.; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; Myra Vision Begins U.S. ADAPT Glaucoma Study, Treating First Participant
Seno Medical’s Next-Generation Imagio® Imaging System Obtained European Union (EU) Medical Device Regulation (MDR) CE Mark Certification On January 26, 2026, Seno Medical received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100, confirming that the device met the stringent ...
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Jan 22, 2026
Sonomotion Secures FDA Clearance for Break Wave™ Lithotripsy System; Aidoc Earns FDA Clearance for Comprehensive AI Foundation Model in Healthcare; BD and Ypsomed Deepen Partnership to Serve Expanding Biologics Market; Omnia Medical Launches FDA-Approved PsiF DNA™ System to Market; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; NEURO PMR Data Validates Hyperfine’s Diagnostic Precision and Patient-Centered Care
Sonomotion Announced FDA Clearance for its Break Wave™ Lithotripsy Device for Treatment of Kidney Stones On January 21, 2026, SonoMotion, a venture-backed medical device company focused on developing non-invasive solutions for kidney stone treatment, announced that it had received U.S. Food and Drug Admini...
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Jan 08, 2026
Gore Secures FDA Approval for Its First Deep Venous Stent for IVC and Iliofemoral Veins; Stereotaxis Secures FDA Approval for MAGiC Ablation Catheter; Stimlabs® LLC Announces FDA 510(k) Clearance and Launch of Allacor P™ for Wound Care; CorePlus and AIxMED Join Forces to Deliver AI-Powered Bladder Cancer Detection with Complete QC; Interim Clinical Outcomes at Six Months from the SPARTAN Study Evaluating the TransLoc 3D™ System; TYBR Health Reports First U.S. Clinical Use of the B3 GEL™ System
Gore Gained FDA Approval for First Deep Venous Stent Indicated for the IVC and Iliofemoral Veins On January 06, 2026, W. L. Gore & Associates’ medical business (Gore) announced that it had received FDA approval for the GORE® VIABAHN® FORTEGRA Venous Stent, formerly known as the GORE® VIAFORT Vascular S...
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Jul 10, 2025
Intuitive’s da Vinci 5 Gets CE Mark; Boston Scientific’s FARAPULSE™ Secures Expanded FDA Approval; Trividia Health’s TRUE METRIX® Added to Pennsylvania Medicaid List; Cerapedics’ PearlMatrix™ Sees First U.S. Clinical Use Post-FDA Nod; Smith+Nephew Expands Q-FIX◊ with Knotless Option; Cochlear Unveils World’s First Smart Cochlear Implant
Intuitive’s da Vinci 5 Surgical System Received CE Mark On July 02, 2025, Intuitive, widely recognized as a pioneer in robotic-assisted surgery and minimally invasive care, announced that its latest system, the da Vinci 5, had secured CE mark approval for use in both adult and pediatric patients across Eur...
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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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Feb 29, 2024
Profound Medical and Siemens Entered Into a Collaboration; CardiAI and Carleton University Forged an Innovative Partnership; BrainMD Launched Revolutionary Smart Collagen Supplements; FDA Approved Seastar’s Quelimmune Device; Nebraska-developed Surgical Robot Received FDA Approval; Catheter Precision Presentated First Clinical Data on LockeT
Profound Medical and Siemens Healthineers Entered Into a Collaboration on Ultrasound Ablation On February 27, 2024, Profound Medical entered into a non-exclusive agreement with Siemens Healthineers. The objective of the agreement was to establish the foundation for Profound's commencement of marketing a comprehe...
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Jan 04, 2024
HR Pharmaceuticals Announced Collaboration with Poiesis Medical; Enovis Acquired Lima Corporate; AnX Robotica Announced FDA Clearance for ProScan; FDA Breakthrough Device Designation for CGBio’s ‘NOVOSIS PUTTY’; EndoSound Received 510(k) Clearance for Breakthrough EVS Innovation; Boston Scientific Initiated AVANT GUARD Clinical Trial
HR Pharmaceuticals, Inc. Received Exclusive Commercialization Rights to Poiesis Medical’s Dual Balloon Catheter Technology in North America On December 28, 2023, HR Pharmaceuticals entered into a collaboration with Poiesis Medical LLC, to license Poiesis's Dual Balloon Catheter (Duette™). According to the terms ...
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Dec 21, 2023
Integra to Buy J&J’s Acclarent; B. Braun Launches the CARESITE Micro Luer Access Devic; FDA Approves Medtronic’s Novel PulseSelect Pulsed Field Ablation System; FDA Clearances to Perfuze’s Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment; ShiraTronics Successfully Implants First Migraine System; Sight Sciences Announced the Six-Month Results For Heat Therapy Device
Integra LifeSciences to Buy Johnson & Johnson’s Acclarent and its ENT Tech On December 13, 2023, Integra LifeSciences entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech. Acclarent strengthens Integra's position in the ENT treatment market. Acclarent is a component of ...
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Dec 14, 2023
Micro Medical Solutions’s Pivotal STAND Clinical Trial; AcelRx’s Continuous Renal Replacement Therapy; Kaneka Acquired Japan Medical Device Technology; Tandem Diabetes Care Launched t:slim X2 Insulin Pump Software; ZimVie’s Vital Spinal Fixation System and Brainlab Spine & Trauma Navigation; NeuroOne’s OneRF Ablation System
Micro Medical Solutions Announced Completion of Enrollment in Pivotal STAND Clinical Trial On December 6, 2023, Micro Medical Solutions (MMS) made an announcement on the completion of a pivotal clinical study enrollment in the United States. MMS microvascular intervention is intended to improve clinical outcomes...
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Nov 30, 2023
Baird Medical’s Microwave Ablation System; BrainSpec’s AI-Backed Solution for Non-Invasive Brain Chemistry Measurement; AWAK’s AI-Enabled Kidney Disease Prediction Tool; Revvity’s EONIS Q System; FormaPath Announced Advancement in Cancer Pathology; Pramand Launched CraniSeal Dural Sealant
Baird Medical Received the US FDA Clearance for a Microwave Ablation System On November 22, 2023, Baird Medical announced the US Food and Drug Administration clearance of the company’s microwave ablation (MWA) system and disposable needles for use in the US. The clearance allows the use of the technology to a...
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