OraSure Technologies (Nasdaq:OSUR) announced today that received a government contract to develop a second-generation Ebola diagnostic. The Biomedical Advanced Research and Development Authority (BARDA) issued the company the $8.6 million contract. Bethlehem, Pennsylvania-based OraSure is to develop the test on its OraQuick testing platform. Its aim is to improve sensitivity, increase shelf life, introduce new […]
OraSure Technologies Inc.
Markey wants COVID-19 test-makers to lower prices
Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece. In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can […]
BSX touts FDA nod for spinal cord lead | Regulatory Roundup
Boston Scientific Corp. (NYSE:BSX) landed FDA clearance for its Infinion 16 percutaneous lead, designed for use with the company’s Precision Plus spinal cord stimulator system to control chronic pain.
The Infinion 16 lead is the first 16-contact percutaneous lead on the global market, doubling the previous max of eight stimulating contacts, according to the Natick, Mass.-based med-tech titan.
Medtronic regulatory chief Susan Alpert to step down
Medtronic Inc.’s (NYSE:MDT) chief regulatory affairs officer Susan Alpert will join her boss, William Hawkins, on Retirement Row this year, according to company officials.
Alpert, who has held the senior vice president and chief regulatory officer positions at Medtronic since 2005, had a similar role at C.R. Bard (NYSE:BCR) before joining MDT and is also a former director of the FDA’s Office of Device Evaluation .
Entellus wins FDA clearance for sinus endoscope | Regulatory roundup
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
