US FDA clearances

Medrobotics Corp. received FDA regulatory clearance to market the Flex Robotic System for robot-assisted visualization in general surgical, gynecological, and thoracic procedures in the U.S.

Surmodics Inc. has received 510(k) clearance for its Telemark 0.014” coronary and peripheral support microcatheter. The company is making this product available for U.S. distribution in the coming months. The microcatheter combines Surmodics’ Xtreme composite shaft technology with a high-performance Pristyne hydrophilic coating, providing deliverability, kink resistance, and lesion crossing. Surmodics’ Pristyne hydrophilic coating offers lubricity and low particulates.

Stryker’s Spine division received 510(k) clearance for its Tritanium C Anterior Cervical Cage 3D-printed interbody fusion cage, constructed from Stryker’s Tritanium In-Growth Technology, a highly porous titanium material designed for bone in-growth and biological fixation. Tritanium’s porous structure is designed to support cell attachment and proliferation. It is inspired by the microstructure of cancellous bone and enabled by AMagine, Stryker’s approach to implant creation using additive manufacturing.

MedAccred for Solar Atmospheres

Demonstrating Solar Atmospheres of Western PA’s ongoing commitment to customer quality while complying with future medical industry specifications, the company has received MedAccred Heat Treating accreditation. They became the eighth plant internationally and the fifth plant domestically to receive this certification.

“Being accredited by this oversight program not only sharpens our quality system even further, it also places Solar Atmospheres on a very short list of heat treaters capable of passing the arduous audit criteria,” says Michael Johnson, sales manager for Solar Atmospheres of Western Pennsylvania.