The FDA is satisfied with Intuitive Surgical's ($ISRG) corrective actions taken in response to a July warning letter that cited the company for failing to notify the agency within 10 days of making changes or corrections to the da Vinci System, a platform for robotic surgery.
The specific violations cited were failing to notify the FDA about safety communications to clients regarding the proper use of certain accessories and proper device maintenance and transportation, failure to notify the FDA about letters to clients describing improper promotion for off-label use, and failure to notify the FDA about letters to clients that warned against using the system in pediatric patients and changed the types of patients and conditions for which it is indicated.
It appears Intuitive has taken steps to address these issues. "Future FDA inspections regulatory activities will further assess the adequacy and sustainability of these corrections," wrote FDA Director of Compliance Lawton Lum in an April 25 letter to Intuitive CEO Gary Guthart.
"We employ rigorous processes in designing, manufacturing and servicing da Vinci Surgical Systems for safety and reliability. We worked diligently to resolve the violations noted by the FDA in the July 16, 2013 Warning Letter and are pleased that the FDA has determined that the violations have been addressed," said Intuitive in an e-mailed statement.
This is good news for a company that has been plagued by concerns about the safety and cost-effectiveness of da Vinci-guided procedures. It issued a recall of more than 1,300 systems in November.
Another problem is that the number of gynecology procedures--which are responsible for almost half of all da Vinci procedures--has been declining recently. Citing power morcellator safety concerns, company officials cut their projections of da Vinci procedure volume growth in 2014 from as much as 12% to as little as 2%, according to a transcript of the company's April 22 earnings call. Since then, Johnson & Johnson ($JNJ) has decided to suspend sales of its power morcellators, which are devices used in uterine fibroid procedures but not sold with the da Vinci System.
Last quarter, Intuitive reported a 24% drop in revenue year-over-year to $465 million; net income fell 76.5% to $44.3 million.
- here's the letter to CEO Gary Guthart
- read the Seeking Alpha transcript