U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA). The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The […]
Dept. of Health & Human Services (HHS)
Biden administration orders home COVID-19 tests
The U.S. Defense Dept. announced today that it awarded Ellume $231.8 to onshore production capacity of its Ellume COVID-19 home test. In coordination with the U.S. Dept. of Health and Human Services (HHS), the DoD contract is an industrial base expansion to allow Ellume to increase the production capacity of its home test by 640,000 […]
HHS could make permanent pandemic-related exemptions for some devices
HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process. In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately […]
MedTech 100 roundup: Industry skyrockets as hot streak continues
The medtech industry’s seemingly unstoppable rise over the past several weeks shows no signs of slowing down. For the fourth time in five weeks, and for the third consecutive week, the MassDevice MedTech 100 Index — which includes stocks of the world’s largest medical device companies — hit an all-time high. Previous highs have largely been […]
HHS seals plan to sunset regulations 10 years or older
The U.S. Department of Health and Human Services (HHS) today issued a final rule giving it five years to review and potentially sunset regulations that have been in place for at least 10 years. With some exceptions, the agency will look into whether regulations cause financial harm to a substantial number of small entities. It will also […]
House Dems subpoena Azar, Redfield on questions of political pressure at CDC
A Congressional committee subpoenaed top Trump administration officials today, demanding documents they allege could show “extensive” pandemic-related political interference at the CDC. In a letter to Health and Human Services secretary Alex Azar and Centers for Disease Control and Prevention director Dr. Robert Redfield, House Democrats said an investigation showed that efforts to interfere with […]
The top 5 MassDevice stories of the week — December 11, 2020
The medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more. This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat. Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will […]
Biden makes picks for HHS secretary, CDC director
President-elect Joe Biden has made selections for leaders of the U.S. Dept. of Health & Human Services and the Centers for Disease Control & Prevention. Biden chose California Attorney General Xavier Becerra as his nominee for HHS secretary. The 12-term veteran of U.S. Congress had previously advocated for healthcare issues as AG in California and […]
HHS confirms involvement in presidential transition process
U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential […]
Are Stephen Hahn’s days numbered at FDA?
HHS Secretary Alex Azar has been reportedly discussing the removal of Dr. Stephen Hahn as FDA commissioner, according to Politico. The Politico report cited a half dozen current and former administration officials. FDA spokesperson Michael Felberbaum in an email to MassDevice denied an Azar-Hahn feud: “Commissioner Hahn enjoys a good relationship with Secretary Azar and […]
MedTech 100 roundup: Industry continues its ascent
Stocks in the medtech industry maintained their upward trajectory, topping last week’s peak with yet another rise to new heights. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 95.66 (Oct. 16), marking a 0.6% gain from the 95.05 points registered at the end of […]