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Sonablate’s manufacturing plant in Charlotte, N.C., landed a Form 483 after an FDA investigator found numerous issues with complaint reviews and reporting.
Roche Diabetes Care has lost its second appeal of the U.S. Patent Office’s (USPTO) rejection of a blood glucose electrochemical sensor as unpatentable.
Three subsidiaries of Johnson & Johnson (J&J) who work in medical robotics have filed a lawsuit in the U.S. District Court in Northern California against Noah Medical and 13 individual defendants, claiming three former employees and 10 others collectively stole 26,000 documents of trade secret materials.
The platform showed a sensitivity of more than 98 percent in finding the extent of cancer in patients who have intermediate-risk disease — the most frequently treated form of prostate cancer. Read More
Smiths Medical has issued an urgent medical device correction letter to customers warning that its CADD (computerized ambulatory delivery device) infusion sets for use with CADD pumps could fail to deliver an infusion or could set off a false alarm. Read More
The EU is considering a proposal to delay by several years the compliance deadline for its Medical Device Regulation (MDR) which was to go into effect May 26, 2024, as there are insufficient resources to meet the deadline required by law. Read More