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.
X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.
X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
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.
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.
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.
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.
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.
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.”
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.
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.
"Receiving this first FDA clearance for our retinal camera is not just a milestone, it's a leap forward in our quest to safeguard the vision of millions," said Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia. "We're now focused on obtaining De Novo classification for ocular oximetry, a breakthrough biomarker that promises to revolutionize how we diagnose and manage a variety of ocular conditions."
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