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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.
Mg OSTEOINJECT Receives 510(k) Clearance for Expanded Indications
Mg OSTEOINJECT is the first drillable, adhesive, and injectable bone void filler in the U.S. to incorporate magnesium, a critical component for bone health and development.
FDA Accepts & Closes LimiFlex PMA Module
The LimiFlex DST is the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis. is the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis.
Renovia Receives FDA Clearance for leva Pelvic Health System as 1st Line RX for Chronic Fecal Incontinence
leva Pelvic Health System is designed to treat FI through helping women strengthen their pelvic floor muscles, including the puborectalis muscle, the muscle that acts as a sling around the rectum and the vagina and contributes directly to fecal continence.
Xoran Technologies Submits FDA 510(k) Application for TRON
The benefits of truly mobile compact devices cannot be underscored, and now by engineering the success of our head CT systems into an open-bore system, we are able to drive a new generation of Xoran's point-of-care (POC) imaging devices," said Misha Rakic, Xoran CEO.
Renuvion Dermal Handpiece for Wrinkle-Reduction Procedures Cleared by the FDA
The Renuvion Dermal handpiece for specific dermatological procedures is for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.
Medtronic Receives Spine Industry’s First and Only FDA Clearance for Breakthrough Device Indicated for Ligament Augmentation
Medtronic advises LigaPASS™ is the first and only FDA cleared device with indication for ligament augmentation in spine surgery.
FDA Approves First Systemic Treatment for Alopecia Areata
Alopecia areata, commonly referred to as just alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps. Olumiant is a Janus kinase (JAK) inhibitor which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
Ekso Bionics Receives FDA Clearance to Market its EksoNR Robotic Exoskeleton for Use with Multiple Sclerosis Patients
EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, an indication which significantly expands the device’s use to a broader group of patients.
Santersus NucleoCapture Technology Designated as a Breakthrough Device for the Treatment of Sepsis by the US FDA
The device is a first-in-class, fully-functional product designed to remove circulating neutrophil extracellular traps (NETs) from blood reports Santersus.
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