The U.S. FDA’s draft guidance for predetermined change control protocols for all device types fills in a gap left by previous draft guidance, but there is one potential stopping point for class III devices.

A new brain-computer interface (BCI) developed at UC Davis Health is able to translate brain signals into speech with up to 97% accuracy – the most accurate system of its kind.

Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.

Cresilon Inc. secured U.S. FDA clearance for Traumagel, a hydrogel that stops potentially life-threatening bleeding in seconds. Cresilon designed the product for use by the U.S. military, first responders and medical professionals to swiftly and effectively stop bleeding from traumatic wounds

Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.

The U.S. FDA’s effort to regulate lab-developed tests was predictably controversial, but the final rule drew a second lawsuit, this time from the Association for Molecular Pathology.

Johnson & Johnson aims to add a fourth cardiac business to its portfolio in less than two years with the acquisition of V-W aveLtd., which makes the Ventura interatrial shunt system for the treatment of heart failure. J&J will pay $600 million up front and an additional $1.1 billion contingent on meeting specified regulatory and commercial milestones. The deal is slated to close before the end of the year.

Johnson & Johnson (J&J) aims to add a fourth cardiac business to its portfolio in less than two years with the acquisition of V-Wave Ltd., which makes the Ventura interatrial shunt system for the treatment of heart failure. J&J will pay $600 million up front and an additional $1.1 billion contingent on meeting specified regulatory and commercial milestones. The deal is slated to close before the end of the year.

The COVID-19 pandemic drove a large volume of in vitro diagnostic test efforts toward the SARS-CoV-2 virus, such as the Biofire respiratory panel by Biofire Diagnostics LLC, of Salt Lake City, a test for which the U.S. FDA released the special controls.

Privacy legislation was passed and implemented in the European Union, but the picture in the U.S. is pockmarked by state legislation, a scenario that raises concerns about a fractured and impracticable compliance regime.