The U.S. Court of Appeals for the Federal Circuit recently returned a decision in a case pitting Shockwave Medical Inc. against Cardiovascular Systems Inc. in a decision that adds a new wrinkle to the question of how prior art can and cannot be used to eviscerate a patent.
The U.S. Federal Trade Commission announced a $14.6 million grant it received for an upgrade of its IT infrastructure. The same grant mechanism is leveraged by the Department of Justice, which is a clear sign that U.S. enforcement will be more vigorously enabled by sophisticated analytics going forward.
The ink is barely dry on the draft Medicare physician fee schedule for 2026, but three cardiology societies blasted the draft for cutting rates for left atrial appendage closure procedures – a move they said needlessly endangers patients.
Understanding neurological disease requires several things, including a clear view of the connectome, and the U.S. National Institutes of Health may have a solution in the form of a new MRI system that allows the user to examine neural connections at the mesoscopic and microscopic scales.
An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.
The U.S. FDA posted an update on the early alert for the Novum IQ infusion pump by Baxter International Inc., which includes a suggestion that the administration set be moved half an inch farther down the line before doubling the bolus infusion rate.
Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
The Trump administration released an action plan for AI, which includes an exports program for full-stack AI in areas such as health care. The announcement drew the support of the Advanced Medical Technology Association, which described the initiative as an accelerant for the use of AI in health care and a boon to patient outcomes.
New guidance by the Medical Device Coordination Group spells out many of the routine aspects of compliance with the In Vitro Diagnostic Regulation, but test developers should remain aware of the tripwires in connection with modifications to both the test and the test’s performance studies.
There are times when a casual observer can’t tell whether the medical device industry’s messaging is getting through to policymakers, but a July 17 announcement by the Trump administration clearly signals the effectiveness of at least one med tech messaging strategy.
