Category:
FDA
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.
Cellmyx Announces FDA 510(k) Clearance for intelliFat® BOD™ (Ref.# K210528)
Cellmyx notes this is the most advanced, quickest, and easiest, single-use kit for macro, micro, and nano fat tissue harvesting, processing, and transfer.
FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs
FDA notes the request includes $3.7 billion in budget authority – an increase of $356 million, and $3 billion in user fees – an increase of $153 million.
HLT Gains FDA Approval for Two TAVR Clinical Studies
HLT advises the studies will assess the performance of its HLT Meridian® TAVR® Valve System to treat aortic stenosis and aortic regurgitation for high-risk patients suffering from aortic disease
ArthroFree Wireless Camera System for Minimally Invasive Surgery Receives FDA Market Clearance
ArthroFree Wireless Camera System incorporates the company’s proprietary low-heat, high-intensity Meridiem™ light technology along with advanced camera, battery, and wireless transmission technologies.
Cerus Endovascular Receives FDA 510(k) Clearance of its 027 Micro-catheter
Cerus Endovascular also reports expansion of its Contour Neurovascular System™ Platform
Wision AI Expands U.S. Offerings to Combat Colorectal Cancer With Multiple Screening Tools
Wision AI notes: Obtaining 510(k) Clearance from the FDA for EndoScreener and initiating a US based investigational validation of the new tool for histopathological diagnosis demonstrates how our broadened, enriched AI portfolio can help to reduce colorectal cancer and improve patient outcomes
Solus Gold Embolization Device Receives FDA Clearance
Solus Gold Embolization Device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
FDA Continues Co-sponsorship of MedCon Conference with AFDO/RAPS Healthcare Products Collaborative
FDA reports the event will bring together medical device regulators & industry experts from around the world for content-rich conference sessions that include uncommon collaboration, deep dialogue, and networking as close as your computer.
Fresenius Kabi Receives U.S. Food and Drug Administration 510(k) Clearance for Wireless Agilia® Connect Infusion System with Vigilant® Software Suite-Vigilant® Master Med Technology
Fresenius Kabi notes their wirelessly connected infusion pump system for hospitals and clinics enables centralized distribution of custom drug libraries and warehousing of infusion data for reporting and analysis
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