This article was originally published in The Gray Sheet
Portable echocardiography system is expected to receive 510(k) clearance by year-end, the company predicts while unveiling the device Nov. 8 at the American Heart Association scientific sessions in Atlanta. The 5.4 pound system allows physicians to "instantly assess and document [left ventricular] function, chamber size, source of murmurs, wall thickness, valve regurgitation, [and] cardiomyopathies," and provides a PowerMap directional color Doppler feature which allows the physician to gauge the direction of bloodflow, the firm says
You may also be interested in...
Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020.
Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.
AstraZeneca's research head admits that the half dose approach was a lucky mistake – but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.