medical device
Nov 12, 2026
FX Shoulder Solutions Secures EU MDR Certification for Humelock Reversed® Shoulder System; Bechtel Medical’s Wound VOX™ Receives FDA 510(k) Clearance; MRP Launches VYDENCE ZYE Ultra Multi-Platform Aesthetic Laser System; Health Canada Authorizes Moderna’s mRNA Flu and Flu-COVID-19 Vaccines; i-Lumen Presents i-SIGHT Feasibility Study Findings at CTS Retina 2026; CaliberMRI Launches Quantitative MRI Phantom for Preclinical High-Field Systems
FX Shoulder Solutions, Inc. Achieved EU MDR Certification for Humelock Reversed® Shoulder System On 03 November 2026, FX Shoulder Solutions, Inc. received European Union Medical Device Regulation (EU MDR 2017/745) certification for its Humelock Reversed Shoulder System, marking an important regulatory mile...
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Aug 26, 2026
How is the Active Implantable Medical Devices Market Evolving?
Active implantable medical devices (AIMDs) represent one of the most transformative categories of modern medical technology, combining electronics, materials science, and clinical medicine to deliver therapy or monitoring from within the human body itself. Unlike passive implants such as joint prostheses or vascula...
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Jul 27, 2026
Nanobots in Medicine: Transforming Healthcare from the Inside Out
For decades, the idea of microscopic robots travelling through the human bloodstream to hunt down disease sounded like pure science fiction. That idea is now a serious field of biomedical engineering. Medical nanorobotics sits at the intersection of nanotechnology, robotics, molecular biology, materials science, an...
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Jul 27, 2026
Non-Surgical Body Contouring: What’s Fueling Its Growth in Aesthetic Medicine?
The aesthetic medicine landscape has undergone a profound transformation over the past two decades, moving steadily away from procedures that require incisions, anesthesia, and extended recovery toward technologies that reshape the body with little to no downtime. Non-surgical body contouring sits at the center of ...
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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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Jun 25, 2026
Legacy Expands Diagnostic Portfolio with New York CLEP Approval for Two LDTs; Quest Diagnostics Expands Patient Access to ctDNA MRD Testing with New York Approval of Haystack MRD; MVZ MedDiagnost and Sectra Ink 10-Year Deal to Unify Radiology Network Across 10 Sites; ALZpath and Abbott Enter Global Licensing Deal to Expand Blood-Based Alzheimer’s Diagnostics; Corvention Reaches Key Commercial Milestone with First U.S. Procedure and Balloon Catheter Launch; ZETA SURGICAL® Achieves First Clinical Milestone with Initial Patient Treatment at HOPE Therapeutics
Legacy Received New York State CLEP Approval for Two Laboratory-Developed Tests: Semen Analysis and DNA Fragmentation On 24 June 2026, Legacy announced that the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP), administered by the Wadsworth Center, had validated and approved it...
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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 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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