Tandem Diabetes Care (NSDQ:TNDM) said today it won FDA 510(k) clearance for an expanded pediatric indication for its t:slim insulin pump, now indicated for use in children 6 and older. The San Diego, Calif.-based company said the expanded indication applies to its current t:slim pump features and that there were no changes made to the existing user […]
510(k)
Syneron Medical wins FDA 510(k) for short-wavelength PicoWay laser
Syneron Medical said today it won FDA 510(k) clearance for a new ultra-short 785nm wavelength laser for its PicoWay picosecond laser device. The PicoWay system is an aesthetic laser system designed for removing tattoos of all colors and types and treating pigmented lesions. The system won FDA clearance for the removal of tattoos in November, […]
Relievant Medsystems wins FDA clearance for Intracept ablation device for low back pain
Relievant Medsystems said today it won FDA 510(k) clearance for its Intracept intraosseous nerve ablation system designed for the treatment of chronic lower back pain. The company touted the system as the 1st specific therapy to relieve chronic lower back pain which has persisted for at least 6 months and not responded to conservative care […]
Medtronic wins 1st FDA nod for cement-augmented spine screws
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its CD Horizon fenestrated cement-augmented spinal pedicle screw set, designed to be used with Medtronic’s HV-R polymethylmethacrylate fenestrated screw cement. The company touted the win as the 1st FDA approval for cement-augmented pedicle screws. The newly FDA cleared screw set is indicated for use at […]
Spirox wins FDA nod for Latera nasal implant
Spirox said today it won FDA 510(k) clearance for its Latera absorbable nasal implant designed to support upper and lower Lateral nasal cartilages to prevent nasal valve constriction or collapse. The Menlo Park, Calif-based company said that the device has already been used in its 1st U.S. cases post-approval. “Latera is an important development for nasal obstruction […]
NovoCure wins FDA nod for next-gen Optune device
NovoCure (NSDQ:NVCR) said today it won FDA premarket approval for its 2nd-generation Optune system designed to treat glioblastoma patients. The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields” to inhibit cancer cell replication and cause cancer cell death. The next-generation device is smaller, lighter and […]
Tela Bio wins FDA nod for OviTex hernia repair bioscaffold
Surgical reconstruction company Tela Bio said yesterday it won FDA 510(k) clearance for its Ovitex portfolio of ventral hernia repair and abdominal wall construction reinforced bioscaffold products. The Malvern, Penn.-based company said it is launching the portfolio of devices in the U.S. upon receiving clearance from the federal watchdog. “We are committed to collaborating closely […]
FDA clears Vent-Os sinus dilation devices from SinuSys
SinuSys said today it won FDA 510(k) clearance for 2 new Vent-Os sinus dilation devices designed for treating sinusitis symptoms. The Palo Alto, Calif.-based company said it won clearance for 2 new devices which allow dilation of the frontal and sphenoid sinuses. “The Vent-Os system is easy to deploy and enables physicians to bring the […]
JustRight Surgical wins FDA 510(k) for 3mm pediatric vessel sealing system
JustRight Surgical said today it won FDA 510(k) clearance for its JustRight 3mm pediatric surgery vessel sealing system. The Boulder, Colo.-based company touted the win as the 1st and only from the FDA for an electrosurgical device designed specifically for pediatric patients. “Pediatric surgeons have been requesting ‘right-sized’ surgical instruments and technologies for years. This […]
Accuray wins FDA nod for Radixact image-guided radiotherapy
Accuray (NSDQ:ARAY) said today it won FDA 510(k) clearance for its Radixact treatment delivery platform designed for image-guided radiotherapy treatments designed for cancer patients. The company said it also won FDA clearance for its Accuray Precision treatment planning system and iDMS data management system, components of its Radixact treatment platform. “The Radixact system builds upon the […]
SpineGuard wins FDA nod for PediGuard threaded DSG device.
SpineGuard (EPA:ALSGD) said today it won FDA 510(k) clearance for its PediGuard threaded Dynamic Surgical Guidance device designed for pedicle screw insertion. The PediGuard device is available in various designs, the company said, to accommodate both surgeon’s preferences and patient anatomies. “We are very excited by the clearance of our PediGuard Threaded device, which brings […]