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Heather Bresch — daughter of U.S. Sen. Joe Manchin (D-W.V.) and former CEO of Mylan — allegedly played a key role in squelching both a competing epinephrine self-injector and single-dose EpiPens, leaving pricey two-dose brand-name packs as patients’ only options, newly released court documents are claiming. Read More
The Triton technology “will help improve the industry standards for quantifying blood loss in the labor and delivery department,” said Dylan Crotty, president of Stryker's instruments division. Read More
The company has received six FDA 510(k) clearances for its spinal device systems to date, including its Bridge laminoplasty system for relieving pressure on the spinal cord. Read More
During his time as an adviser to the company, Setty played a pivotal role in the launch of its flagship device, the HD Steth, an intelligent stethoscope that features electrocardiogram and phonocardiogram capabilities. Read More
Promaxo recently received 510(k) clearance from the FDA for its office-based MRI platform, a device that can be easily set up in office settings without the need for shielding or facility upgrades. Read More
“This case demonstrates the Department of Justice’s commitment to ensuring that medical device manufacturers do not use improper relationships to influence physician decisionmaking and are transparent about the benefits that they provide to physicians,” said Acting U.S. Attorney Jennifer Williams. Read More
The Rapid Response electroencephalogram (EEG) system, which earned FDA 510(k) clearance in 2017, is designed to rapidly diagnose seizures that can take hours or days to diagnose when using conventional EEG systems, the company said. Read More