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Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement...
Medtronic is recalling seven of its implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to an unexpected and rapid decrease in battery life. FDA said there have been 444 complaints about the devices, and 264...
The rates posted by Novitas Solutions, a Medicare Administrative Contractor, are higher than the rate set in late January, but still considerably lower than the reimbursement rate iRhythm was previously receiving for its wearable heart monitoring...
Hilden, Germany-based Qiagen inherited the test when it acquired the remaining stake in NeuMoDx Molecular for $248 million in 2020. The NeuMoDx assay's Emergency Use Authorization comes at a time when developments in COVID-19-related tests are...
With enough time and money anything can be hacked, but here are some pro tips on how medical device manufacturers can safeguard embedded devices and digital assets.