Visunex wins FDA 510(k) clearance for Panocam LT


Fremont, Calif-based ophthalmic information system developer Visunex Medical said it won FDA 510(k) clearance for its Panocam LT wide-field imaging system for newborns.

The PanoCam LT is a small wireless imaging system designed to detect external, anterior and posterior segment vision disorders that could have long-term effects on children’s vision, the company said.

“We are launching the Panocam LT which is the first completely wireless,...

SYMBIS Brain Biopsy Robot FDA 510(k) Cleared for Procedures Inside MRI


Deerfield Imaging (Minneapolis, MN) received FDA green light to introduce its SYMBIS stereotactic brain biopsy system in the U.S. The robotic system allows for a biopsy to be performed while the patient is inside an MRI scanner, with the goal being improved targeting and faster procedure times. Being able to visualize the target while working toward reaching it can significantly improve tissue sampling, hopefully also reducing repeat biopsies.

Since IMRIS, a part of Deerfield Imaging, produces intra-op MRIs, the...

Si-Bone wins FDA 510(k) clearance for iFuse sacroiliac joint system

by Fink Densford for

Si-Bone said today it won FDA 510(k) clearance for its minimally invasive iFuse implant system designed for fusion of the sacroiliac joint.

The device is cleared for treating certain disorders of the sacroiliac joint, and its indication includes a statement that treatments with the device “improved pain, patient function...

Reflexion Health Digital Medicine Therapy Tool, Vera™ Receives FDA 510(k) Clearance

by Reflexion Health

San Diego based Reflexion Health, a digital medicine company using Microsoft Kinect motion-tracking technology to re-imagine rehabilitation medicine; today announced the US Food and Drug Administration (FDA) has cleared its motion-tracking based physical therapy tool, Vera™.

Vera is an easily operated, digital medicine software system using the Microsoft Kinect technology to aid patients with musculoskeletal rehabilitation. Vera projects an avatar onto a screen, coaches and motivates patients to perform...

kBLASTER update October 2015: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from September 2015 and FDA 510(k) splash pages for 510(k)s clearances in October 2015. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

With nearly 62,000 510(k)...

Mauna Kea wins FDA 510(k) clearance for Cellvizio

by Fink Densford for

Mauna Kea (ENT:MKEA) said yesterday its Cellvizio confocal laser endomicroscopy platform won FDA 510(k) clearance for use during surgical procedures for treating multiple types of cancer.

The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level,...

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

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

by Fink Densford for

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...