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According to the company, the test offers performance comparable with reverse transcription polymerase chain reaction (RT-PCR) analyses that use nasopharyngeal swabs. Read More
Establishing the EU reference laboratories (EURLs) for a range of Class D devices has been identified as an important priority and the European Commission is working on introducing the criteria and fees for the EURLs. Read More
Innova said it will significantly increase U.S. production capacity for the newly acquired company and intends to localize its manufacturing in international markets, including the UK, Europe, Asia and other regions. Read More
The company said its submission is meant to bring its regulatory clearance for the system up to date, implement updated features and address the issues it’s seen with recalls. Read More
The complaint alleged that the devices “were not properly cleared for any use” and “they cannot be used for their labeled intended use (and are thus not substantially similar to the predicate device).” Read More
MedShape uses superelastic nickel titanium technology to develop devices that respond to changes at the surgical site, including bone resorption, and maintain compression and bony apposition through the healing process. Read More
The device does not directly contact blood flow, limiting the risk of thrombosis, stroke and infections that can occur from devices implanted inside the heart. Read More
Using automated software analysis and the company’s PlexPrep liquid handling system, 480 to 1,920 patient samples can be processed in an 8-hour shift, the company said. Read More
China’s National Medical Products Administration reported that in 2020, the country’s medical device adverse event monitoring system received a total of 536,055 medical device adverse event reports, an increase of more than 35 percent on the previous year. Read More
The FDA has reversed a Trump Administration policy that was set to exempt 83 class II devices and one unclassified device from premarket notification requirements. Read More