From Seeking Alpha -
Philips (NYSE:PHG) lost ~8% in the pre-market Friday after the U.S. FDA said that the Dutch medical device maker has not shared sufficient details with the regulator regarding a major recall of its sleep apnea and respiratory care devices.
ResMed (RMD), a major rival of PHG in the sleep care market, added ~4% in reaction. Its other competitors in the industry include Inspire Medical Systems (INSP) and Owens & Minor (OMI).
"The FDA has reviewed the available information and data provided to FDA by Philips. We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices," the agency said on Thursday.
While the company concluded that these devices have no significant health risks to patients, "the FDA believes additional testing is necessary," the regulator added.
While agreeing with the FDA's remarks on the need for more testing, Philips (PHG) said currently, five independent laboratories test the recalled products. The company added that it was in talks with the agency for further details.
"Philips' first priority is the health and well-being of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care devices under the recall," Reuters reported, citing a statement from the company.
Philips (OTCPK:RYLPF) has lost over 60% of its market value since it recalled millions of sleep apnea and ventilator machines in June 2021 over potential health risks.
