Medical Devices Market
Jul 09, 2026
Presage Technologies Unveils Free Access to FDA-Cleared Contactless Vital Signs Technology; CliniComp Secures FDA Clearance for MIMPS PACS Viewer with Unified Imaging and AI Capabilities; Advita Ortho Strengthens the Scientific Foundation for Predictive Planning in Total Knee Arthroplasty; RunStar® Expands Health Device Portfolio with New Smart Blood Pressure Monitor; Nyra Medical Initiates ENHANCE Early Feasibility Study with First Patient Enrollment; Penumbra Enrolls First Patient in FORWARD Study for Distal Acute Ischemic Stroke
Presage Technologies Earned FDA Clearance for Contactless Vital Signs, Makes Them Available for Free On 07 July 2026, Presage Technologies announced that its SmartSpectra Vital Signs Monitor 1.0 SDK received U.S. FDA 510(k) clearance (K254169) for both iOS and Android platforms and made the FDA-cleared con...
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Jul 02, 2026
STARMED Secures FDA 510(k) Clearance for Benign Thyroid Nodule Ablation; SciBase Advances U.S. Expansion with FDA 510(k) Submission for Nevisense; ALR Technologies to Acquire CGM Medical Technology in US$45 Million and 200 Million Share Deal; Co-Diagnostics Completes Validation Studies Ahead of FDA 510(k) Submission for Upper Respiratory Point-of-Care Test; Corvention Launches Innovative Balloon Catheter in the U.S. Following First Clinical Case; OrthAlign Reports First Clinical Cases Using Lantern® ASC System
STARMED Received FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication On 01 July 2026, STARMED America announced that it had received FDA 510(k) clearance for the first radiofrequency ablation (RFA) system in the United States specifically indicated for the treatment of benign thyroid nodules. Th...
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Jun 18, 2026
FiberSense CGM System Secures CE Mark; AMDI™ Fast PCR System Achieves FDA 510(k) Clearance and CLIA Waiver for Near-Patient Respiratory Diagnostics; Icarus Medical Raises $7.2 Million Series A to Drive Next-Phase Growth; Crescom and Mass General Brigham Launch Global Proof of Concept for Pediatric Musculoskeletal AI; VahatiCor Reaches Key Milestone with First U.S. Patient Dosed in SERRA-I CMD Study; Sonex Health Unveils Results From Largest-Ever U.S. Investigation of UltraGuideCTR™
FiberSense Continuous Glucose Monitoring (CGM) System obtains CE mark as commercial launch preparations begin On 17 June 2026, FiberSense AG announced that its FiberSense Continuous Glucose Monitoring (CGM) System had received CE marking under Regulation (EU) 2017/745 as a Class IIb medical device. T...
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Jun 11, 2026
Sibel Health Secures EU MDR CE Mark, Subtle Medical Wins FDA Clearance, Roche Acquires PathAI, Carestream Launches Lux HD Detectors, and New Clinical Milestones in Atopic Dermatitis & Carpal Tunnel Care
Sibel Health Received EU MDR Class IIb CE Mark for ANNE® One: The First Wireless Wearable Patient Monitoring Platform Certified to Key Interoperability Standards (Regulatory Update) On 10 June 2026, Sibel Health Inc., an award-winning medical technology company, announced that its ANNE® One system had receiv...
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May 28, 2026
FDA Grants Breakthrough Device Status to TOBY’s Urine Test for Alzheimer’s Detection; ubtle Medical Achieves FDA Clearance for Next-Gen SubtleHD™(PET) Software; Ernest Health Expands Rehabilitation Network Through Reunion Hospitals Deal; Olympus Expands Prostate Cancer Footprint Through BioProtect Acquisition; ABILITY Neurotech Secures IMDD Approval for Clinical Trial of Chronic Brain-Computer Interface Implantation in ALS Patients; Implantica Reports Strong Economic Benefits of RefluxStop® in Italian GERD Treatment Study
TOBY Received FDA Breakthrough Device Designation for Its Urine-Based Alzheimer's Disease Diagnostic Test On 26 May 2026, TOBY, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation to the TOBY Test for Alzheimer’s Disease. The designation recognized th...
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May 21, 2026
Leo Cancer Care Receives CE Mark Approval for Marie® Upright Radiotherapy System; PorTal Access, Inc. Hits Critical Regulatory Benchmark with Flexi-Port™ 510(k) Submission; Araceli Biosciences Introduces Endeavor® Live Cell to Accelerate AI-Driven Drug Discovery Imaging; TrilliumBiO Partners with Oncobit to Launch Next-Generation Uveal Melanoma Monitoring Platform; Advita Ortho Reports First Clinical Application of Equinoxe® Scapula Reconstruction System; Implantica Announces Findings Supporting RefluxStop®’s Economic Advantage in GERD Treatment in Italy
Leo Cancer Care Secured CE Mark for Marie®, Advancing Upright Radiotherapy in Europe On 21 May 2026, Leo Cancer Care announced that its flagship upright radiotherapy system, Marie, had received CE marking approval, enabling commercial deployment across Europe. The approval marked a significant advancement ...
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May 14, 2026
Aurie Wins FDA De Novo Grant for Innovative Reusable Urinary Catheter Technology; Biozen Secures FDA Clearance for Calibration-Free Cuffless Blood Pressure Technology; plusOne® Expands Wellness Care Portfolio with New Menopause and Fertility-Friendly Lubricants; TrilliumBiO and Oncobit Introduce Advanced Uveal Melanoma Monitoring Solution in the U.S.; Renerva Announces First-in-Human Implant of PNM-CAP™ for Neuroma Pain; SonoClear AS Announces Completion of Clinical Enrollment for Breakthrough Device-Designated SonoClear® System
Aurie Received FDA De Novo Grant for First Automated Safely Reusable Intermittent Urinary Catheter System On 11 May 2026, Aurie announced that its Aurie Reusable No-Touch Intermittent Catheter System™ had received marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De No...
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May 07, 2026
Multi4 Medical Gains CE Mark Approval for Office-Based Bladder Cancer Treatment; FX Shoulder Solutions Achieves FDA 510(k) Clearance for FX V135® Easytech Platform; Ortho Development Launches Commercial Rollout of Trivicta® Hip Stem; Clover Podiatry Expands Foot and Wound Care Services With New Advanced Healing Center; CLiMB Study Highlights Superior Sensitivity of HelioLiver™ Blood Test Versus Ultrasound in Detecting Early-Stage HCC; Aqua Medical Unveils Promising DDW 2026 Data Showing Sustained Insulin Elimination in Type 2 Diabetes Patients
Multi4 Medical Received CE Mark - Moves Bladder Cancer Treatment from Operating Room to Outpatient Setting On 05 May 2026, the CE mark enabled the Multi4 System to be commercialized across Europe and represented a major advancement in urologic cancer care. The system introduced the world’s first all-in-one instr...
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Apr 30, 2026
Olympus Secures FDA Clearance for POWERSEAL™ Open Extended Jaw Device; Abbott’s Ultreon™ 3.0 Receives FDA Clearance and CE Certification; LTS Broadens CDMO Capabilities with Ophthalmic Drug Delivery Expertise; BD Transforms Central Line Placement with Groundbreaking Technology; AI Models Deliver Up to 73% Fewer Genome Analysis Errors in New Research; Calidar Finishes Enrollment in First-in-Human Trial of 4D Mammography System
Olympus Received FDA Clearance for POWERSEAL™ Open Extended Jaw Device On 28 April 2026, Olympus Corporation announced that it had received 510(k) clearance from the U.S. Food and Drug Administration for its POWERSEAL™ Open Extended Jaw Sealer/Divider for use in open surgical procedures. The approval marke...
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Apr 23, 2026
Utepreva Announces FDA 510(k) Clearance for Endometrial Sampler Aimed at Early Cancer Detection; Sonorous Neurovascular Announces FDA 510(k) Clearance of BosCATH Neurovascular Catheter; OrganaBio and RxMP Therapeutics Partner to Support Manufacturing of RMP-402 Hemostatic Therapy; RhythMedix Introduces the New RhythmStar® SL Advanced Cardiac Monitor; Nicklaus Children’s Hospital Achieves First Traveling Bedside PDA Closure in Fort Lauderdale NICU; RIVANNA Advances Multi-center Clinical Study of Accuro XV Musculoskeletal Imaging System
Utepreva Introduced FDA 510(k)-Cleared Endometrial Sampler Designed to Support Early Detection of Endometrial Cancer On 22 April 2026, Utepreva LLC announced the launch of the Utepreva Endometrial Sampler, a patented, FDA 510(k)-cleared, single-use endometrial sampling device designed to enhance tissue capture a...
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