HomeFDA
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.
FDA Grants Clearance for UltraSight’s AI-Powered Cardiac Ultrasound Technology
New AI guidance software will allow more medical professionals to conduct cardiac ultrasound in multiple care settings expanding patient access to cardiac imaging.
icotec ag Announces FDA 510(k) Clearance for VADER® Pedicle System Navigated Instruments, Advancing Precision and Safety in Spinal Implantation
This achievement represents a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants.
Octapharma’s Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures
Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy. Balfaxar® is a non-activated four factor prothrombin complex concentrate (4F-PCC) containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S.
Dräger Secures FDA 510(k) Clearance for Evita V600, V800 and Babylog VN800 Ventilators
The Evita V600, Evita V800, and Babylog VN800 ventilators are manufactured by Drägerwerk AG & Co. KGaA.
Invictus Announces FDA Clearance of Ground-Breaking Neoasis ® ANC Device
The Neoasis utilizes a proprietary, innovative active noise control (ANC) system to attenuate noise with canceling sound wave technology. At the same time, it allows a parent’s voice to be directed to the infant, which can also be beneficial for cognitive development.
KORU Medical Systems, Inc. Announces 510(K) Submission for Freedom60® Infusion System With Hizentra® 50 Ml Prefilled Syringes
Linda Tharby, KORU Medical Systems President and CEO. "Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM™ Infusion System as compared to vials. With market data showing significant uptake in prefilled syringe market growth, this 510(k) submission is another innovation milestone for KORU Medical that will further enhance the patient experience and potentially be an additional growth driver for home subcutaneous therapy."
Alcyone Therapeutics Receives FDA IDE Approval to Initiate Clinical Study of the ThecaFlex DRxTM System for Administration of SPINRAZA ® (nusinersen)
"Alcyone is excited to begin the process of evaluating the safety and performance of ThecaFlex in SMA patients being treated with SPINRAZA. ThecaFlex represents the culmination of a deliberate effort to design a delivery system specifically for repeat bolus intrathecal drug delivery," said PJ Anand, Chief Executive Officer of Alcyone Therapeutics. "IDE approval and the impending start of the pivotal study are critical steps toward helping patients in need with a potential therapeutic delivery alternative and improved treatment experience."
FDA clears ImageBiopsy Labs’ latest AI-powered Software for a comprehensive Set of Automated Measurements on Long Leg Radiographs
"FDA clearance serves as a significant validation of the accuracy and quality of our LAMA module. It is a huge milestone to bring AI-supported software tools to surgeons, not only to increase efficiency, but also to improve the outcomes and follow-ups for their patients" said Richard Ljuhar, CEO & co-founder of ImageBiopsy Lab.
FDA Clears CorNeat EverPatch, World’s First Non-degradable, Synthetic Tissue Substitute for Ophthalmic Surgery
CorNeat Vision's EverPatch utilizes EverMatrix™, a novel material technology able to integrate with surrounding tissue.