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Valo Health announced positive results of a five-year collaboration with the FDA to study the potential of cardiac contractility modulation (CCM) to treat heart failure patients using human engineered cardiac tissues to assess the device’s safety.
AdvaMed, joined by eight health advocacy groups, sent a letter to Congressional committee leaders urging year-end passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which was dropped from the user fee reauthorization package passed Sept. 30.
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.