Current regulatory news

FDA 510(k) cleared canaloplasty device

In April, Dr. Mahmouid A. Khaimi was the first surgeon in the U.S. to perform canaloplasty with the iTrack Advance. The surgeries were performed at the Dean McGee Eye Institute.

“I’ve been given the great opportunity to pair hand in hand with Nova Eye Medical to develop the iTrack Advance,” Khaimi says. “We’ve taken the original iTrack canaloplasty microcatheter and teamed it with an ergonomic handpiece that facilitates improved access into the canal.”

Khaimi says the new handpiece will advance and retract the microcatheter of the original product with much greater efficiency than before.

The iTrack Advance was launched in the U.S. at the American Society of Cataract and Refractive Surgery (ASCRS) in May.

Nova Eye Medical
https://itrack-advance.com/us

Tegra Medical achieves ISO 14001

Recently, Tegra Medical achieved ISO 14001 certification in all four of its locations in the United States. ISO 14001 is granted to companies that identify and manage aspects of their business to reduce environmental impact. Certification is established with a baseline determined after an extensive audit of a company’s procedures. The audit is followed by a plan for improvement in selected areas.

“Tegra Medical is emphatically committed to contributing to a greener world for future generations,” says Walter Kobler, Tegra Medical CEO. “As the medical division of SFS, Tegra Medical has made sustainability part of its DNA. It’s a mindset that will deliver value to our stakeholders as we infuse the holistic ESG criteria (environmental, social, governance) into all the work we do.”

Tegra Medical will continue to improve within areas such as material reuse, waste reduction, composting, and evaluating equipment for age and power efficiency.

Tegra Medical
https://www.tegramedical.com