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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval Reports Pulnovo Medical
The PADN technology is a major revolutionary procedure in the field of global interventional pulmonary arterial hypertension (PAH), which breaks the dilemma in PAH interventional therapy.
CGBio’s ‘NOVOSIS PUTTY’ Receives FDA ‘Breakthrough Device Designation,’ Accelerate Entry into the US Market
NOVOSIS PUTTY: The designation marks the first case for implantable device in Korea. Despite being a high-risk permanent implant, NOVOSIS PUTTY's efficacy and innovative aspects are recognized internationally.
Inspira™ Announces 95% Accuracy Results for HYLA ™ Blood Sensor, Planning FDA Submission for Clearance in 2024
The development of the first HYLA ™ variant, key to this advancement, marks a significant step towards its submission under a 510(k) pathway with the U.S. Food & Drug Administration ("FDA"), which is expected in the second half of 2024. This sensor technology is designed to be integrated with the Company's INSPIRA ART100 and was submitted to the FDA in September 2023, with clearance anticipated in the first half of 2024.
Align Technology Receives US FDA 510(k) Clearance for the Invisalign® Palatal Expander System to Address Skeletal and Dental Expansion in Growing Patients, Including Teenage...
Previously introduced at the Align Technology Investor Day in September 2023, the Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology.
Tyber Medical Granted FDA Clearance on Distal Radius Plating System
The Tyber Medical Distal Radius Plating System maintains stability and orientation in the anteroposterior plane utilizing a dynamic grouping of plate length options, offered in titanium or stainless steel.
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
Seladelpar has been granted Breakthrough Therapy Designation by the FDA and is the only potent, selective, orally active delpar, or PPARδ agonist, with Phase 3 trial results demonstrating a statistically significant improvement in markers of cholestasis related to risk of progression and PBC-related pruritus.
DnaNudge Secures FDA approval to Deploy a Multiplex PCR Platform for Diagnosing Four-in-one Respiratory Pathogens in Ghana
Commenting on the announcement of FDA approval in Ghana, Professor Chris Toumazou FREng FRS FMedSci, co-founder of DnaNudge and founder, Chief Scientist of the Institute of Biomedical Engineering at Imperial College London and Laureate of the UNESCO-Equatorial Guinea International Prize For Research in the Life Sciences said: “This milestone approval in Ghana marks the beginning of what we believe will be a seismic shift in the ubiquitous availability of advanced healthcare technology throughout Africa. In partnership with NantNudge, we are now embarking on the first phase of an extensive programme that will see the deployment of our highly multiplexed technology across villages, towns and cities in Africa, delivering equitable access to improved quality of care for communities and reducing costs, complexity and inefficiency for clinical teams and healthcare providers.”
Ad Astra Diagnostics Receives 510(k) Clearance of QScout™ Hematology Analyzer
QScout ™ is the first hematology platform designed for simple, fast operation at the point-of-care. It provides lab-grade, patient-side results that caregivers use to screen for health conditions including infection, leukemia, and other blood-related cancers, allergies, and many more.
BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device
The BD MiniDraw™ Capillary Blood Collection System is less invasive than a traditional venous blood draw by using capillary blood collected from a patient's finger by a trained healthcare worker, without the need for a phlebotomist to collect blood from a vein.