MedTech News

FDA approves Zeiss software that treats nearsightedness
Zeiss Medical Technology announced that the FDA approved the VisuMax 800 with Smile Pro software.

FDA clears painful diabetic neuropathy neurostim therapy from Neuralace
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment.

Zeta Surgical wins expanded FDA nod for mixed reality navigation system
Zeta Surgical announced today that the FDA granted it a special 510(k) clearance for expanded software functionality.

3Spine Announces Completion of FDA Clinical Trial Enrollment Achieving 325 Surgeries in 2023
3Spine’s MOTUS device is a ‘first-of-kind’ breakthrough medical technology indicated for the biomechanical reconstruction and stabilization of a spinal motion segment

Nanoflex Robotics Receives ISO 13485 Certification
The innovative medical robotic startup achieved the globally recognized ISO 13485 certification in December 2023

Neurolief’s Relivion® Secures Regulatory Approval in Japan, Pioneering At-Home Migraine Treatment
Neurolief announces the approval of its neuromodulation device, Relivion®, by the Japanese Ministry of Health, Labor and Welfare (MHLW).

Biosense Webster wins Japanese approval for Varipulse pulsed field ablation
Johnson & Johnson MedTech’s Biosense Webster today announced Japanese approval for its Varipulse platform for treating AFib.

Team develops app to help train the brain to overcome tinnitus
An international research team has shown that the debilitating impact of tinnitus can be effectively reduced in just weeks by a training course and sound therapy delivered via a smartphone app