News

AV Medical Technologies Ltd. Receives FDA 510(k) Clearance for its Chameleon™ Angioplasty Balloon Catheter

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by Business Wire

TEL AVIV, Israel--()--AV Medical Technologies Ltd. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Chameleon™ angioplasty balloon catheter. With its Proximal Injection Port (PIP™) technology, Chameleon™ is the first and only angioplasty balloon catheter that allows for simultaneous balloon inflation and intravascular injection of fluids while maintaining guidewire access. PIP™ technology incorporates...

Pryor Medical wins FDA 510(k) clearance for aortic balloon catheter

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by Fink Densford for Massdevice.com

Minimally-invasive vascular trauma focused Pryor Medical Devices said today it won FDA 510(k) clearance for its ER-Reboa balloon catheter designed to occlude the aorta.

The ER-Reboa is San Antonio, Texas-based Pryor’s flagship product, designed to occlude large vessels using a balloon for treating traumatic injuries, specifically by the critical care and emergency medicine community.

“We are proud to be the first to...

SonaCare Medical Receives FDA 510(k) Clearance for its Sonablate® High Intensity Focused Ultrasound Prostate Ablation Device

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by SonaCare

CHARLOTTE, N.C., OCTOBER  13, 2015 -- SonaCare Medical, LLC, a pioneer in minimally invasive high intensity focused ultrasound (HIFU) technologies, announced today that it received de novo clearance from the U.S. Food and Drug Administration (FDA) to market the Sonablate® 450  in the U.S. for the ablation of prostate tissue. Sonablate® is the first High Intensity Therapeutic Ultrasound (HITU) device to receive FDA regulatory authorization for prostate tissue ablation. SonaCare Medical expects to begin U....

NFANT Labs gets FDA 510(k) nod for smart baby bottle sensors for the NICU

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by NFANT Labs/PR Web

Atlanta-based NFANT Labs LLC today announced that it has received FDA clearance for its nfant® Feeding Solution. Unlike an ordinary baby bottle, nfant® Feeding Solution is the only medical device that can determine an infant’s tongue movement during actual feeding and provide objective, measurable data. Information is then relayed to caregivers through a mobile app and stored in a cloud database. The solution is...

FDA 510(k) clears Medtronic’s Tyrx envelope for DBS devices

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by Brad Perriello for MassDevice.com

Medtronic (NYSE:MDT) said today that it’s launching its Tyrx surgical envelope in the U.S. for use with deep-brain stimulation devices, after it won 510(k) clearance from the FDA for use of the infection-fighting envelope with implantable neurostimulators.

Fridley, Minn.-based Medtronic said it’s...

EarLens wins FDA 510(k) for novel hearing aid

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by Fink Densford for Massdevice.com

EarLens said last Tuesday it won FDA 510(k) clearance for its laser diode-equipped direct vibration-based contact hearing device for use in adults with mild to severe sensorineural hearing impairment.

The device is designed to directly contact the patient’s eardrum and use it as a speaker and act as an amplifier for a wide range of frequencies, the Menlo Park, Calif.-based company said. It consists of a tympanic membrane transducer...

Implanet wins expanded FDA 510(k) clearance for Jazz band device

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by Fink Densford for MassDevice.com

French orthopedic implant company Implanet said Wednesday it won expanded FDA 510(k) clearance for its Jazz spinal implant allowing it to be used with other posterior thoraco-lumbar fixation systems.

The Jazz implant is intended to provide temporary stabilization as a bone anchor during bone fusions and to aid in the repair of bone fractures.  The device is cleared for spinal trauma surgeries, spinal reconstructive surgeries and spinal degenerative surgeries, according to...

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