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The FDA announced it is publishing a guidance on a proposed rule to reclassify pressure regulators for use with medical oxygen from Class I to Class II.
Conor Medsystems, a subsidiary of Johnson & Johnson, announced it plans to present the results for its COSTAR II pivotal clinical trial at the EuroPCR meeting in Barcelona, Spain, in May.
With daylight-saving time starting several weeks earlier this year thanks to a new law, device firms will need to be sure that software and operating systems installed in their products are prepared to "spring forward" by March 11.
The market for biomaterials is expanding as medical device manufacturers seek to integrate lighter, safer, sturdier materials into implantable products such as drug-eluting stents, an analyst said in a recent briefing.
Sparta Systems released a new version of its software that allows companies to electronically submit their medical device reports (MDRs) to the FDA, the company announced.
Corin has overcome several obstacles -- including patients refusing to participate in the control arm of its clinical study -- to gain a favorable FDA advisory committee panel vote of 4-1 recommending that the agency allow the firm to market its joint device.
The fallout of the recent removal from the U.S. market of external defibrillators manufactured by Medtronic's Physio-Control unit is still unpredictable, according to RBC Capital Markets analyst Phil Nalbone.