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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
Abbott Laboratories’ CardioMEMS implantable heart failure monitor missed the primary endpoint in an expanded patient population, but the company said that COVID-19 may have skewed the results. Read More
The FDA is getting back its rulemaking authority, which was significantly weakened under President Trump, as the Biden administration reverses multiple policies from the previous administration. Read More
The FDA issued an update on which types of devices may be offered as over the counter (OTC) devices and what devicemakers should consider when making the switch from prescription to OTC status. Read More
Other Hailie Sensors will follow in the coming year, providing physiological measures that include inhalation duration, volume and peak inhalation flow for 18 medications, the company said. Read More
Vonco Products is a contract manufacturer of liquid-tight medical fluid bags and devices, biohazard transport and infection prevention personal protective equipment. Read More
The device was deigned to “optimize fusion, while maintaining elasticity that is similar to bone and radiolucency of the cage body,” the company said. Read More