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Balloon-expanding covered stents are frequently used to treat arteriosclerotic lesions in renal and iliac arteries, as well as aneurisms and ruptures. Read More
The device provides 24/7 bedtime monitoring and aids in faster diagnosis and monitoring, a critical factor for sepsis treatment in which reacting quickly is essential. Read More
The pressure monitor, which comes with BlueTooth capabilities, delivers a continuous pressure microsensor directly into the patient’s muscle. Read More
The FDA issued a final rule that updates the descriptions of eight software functions that don’t meet the definition of medical device under the 21st Century Cures Act, effectively removing certain software from regulation. Read More
The European Commission’s Medical Device Coordination Group issued guidance for devicemakers of high-risk Class D in vitro diagnostics on applications during the transition period for the EU Invitro Diagnostic Regulation (IVDR) which will go into effect on May 26, 2022. 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
Validation procedures for testing finished devices and software validation procedures related to Koko’s Px pulmonary function testing devices were observed to be inadequate during a Jan. 5-25, 2021 FDA inspection of the firm’s Longmont, Colorado facility. Read More
Failure to adequately validate its purified water system resulted in possible contamination of several lots of Sunstar Americas’ oral hygiene products, the FDA discovered during a Jan. 12 to Feb. 18 inspection of the firm’s Schaumburg, Illinois manufacturing facility. Read More
The FDA issued five new warning letters last month related to misbranded and adulterated COVID-19 tests, as the agency continues to urgently target manufacturers and suppliers of unapproved COVID-19 products. Read More
The European Commission is calling on EU standardization groups to revise more than 200 existing harmonized standards and to draft 27 new standards over the next three years in support of the EU’s Medical Device Regulation and In Vitro Device Regulation. Read More