Lasermedics
This article was originally published in The Gray Sheet
Executive Summary
Plans to submit a premarket approval application to FDA within 90 days for its Microlight 830 nonsurgical cold laser for the treatment of repetitive stress injuries, including carpel tunnel syndrome. The Missouri City, Texas firm says that the device's 510(k) submission, submitted in September 1993, was deemed "not substantially equivalent" by the agency. The PMA will include data from a General Motors study involving 160 patients with chronic CTS. In addition, Lasermedics plans to submit a protocol to the agency by Feb. 1 to expand ongoing clinical trials for the Microlight to include additional conditions such as arthritis, wound healing and periodontal disease
You may also be interested in...
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.