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Dept. of Health & Human Services (HHS)

MedTech 100 roundup: Industry skyrockets as hot streak continues

January 11, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Featured, Funding Roundup, MassDevice Earnings Roundup, Mergers & Acquisitions, Research & Development, Wall Street Beat Tagged With: Amazon, Berkshire Hathaway, CES, coronavirus, COVID-19, COVID-19 vaccine, Dentsply Sirona, Dept. of Health & Human Services (HHS), Dow Jones, Henry Schein Medical, Hologic, JP Morgan Chase, MedTech 100 Index, PerkinElmer Inc., S&P, Smith+Nephew, Stryker

HHS seals plan to sunset regulations 10 years or older

January 8, 2021 By Nancy Crotti Leave a Comment

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 […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: Dept. of Health & Human Services (HHS)

House Dems subpoena Azar, Redfield on questions of political pressure at CDC

December 21, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Legal News Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Dept. of Health & Human Services (HHS), U.S. House of Representatives

The top 5 MassDevice stories of the week — December 11, 2020

December 11, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Legal News, Neurological, Neuromodulation/Neurostimulation, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, Boston Scientific, Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Dept. of Health & Human Services (HHS), FDA, Joe Biden, Medtronic, Pfizer, Quest Diagnostics Inc.

Biden makes picks for HHS secretary, CDC director

December 7, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Dept. of Health & Human Services (HHS), FDA, Joe Biden

HHS confirms involvement in presidential transition process

November 25, 2020 By Sean Whooley

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 […]

Filed Under: Featured, Legal News, Pharmaceutical Tagged With: AstraZeneca plc, BioNTech, coronavirus, COVID-19, Dept. of Health & Human Services (HHS), Joe Biden, Moderna, Pfizer

Are Stephen Hahn’s days numbered at FDA?

October 22, 2020 By Chris Newmarker

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: Dept. of Health & Human Services (HHS), FDA, Stephen Hahn

MedTech 100 roundup: Industry continues its ascent

October 19, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Diagnostics, Featured, Funding Roundup, Genomics/Molecular Diagnostics, Initial Public Offering (IPO), MassDevice Earnings Roundup, Mergers & Acquisitions, Replacement Heart Valves, Research & Development, Structural Heart, Wall Street Beat Tagged With: Boston Scientific, coronavirus, COVID-19, Cue Health, Dept. of Health & Human Services (HHS), Eargo, MedTech 100 Index, Medtronic, Pfizer, Siemens Healthineers, Varian Medical Systems

Labor unions, environmental groups sue feds over lack of PPE

October 8, 2020 By Sean Whooley

Labor unions ranging across several types of frontline workers today joined environmental groups in a lawsuit against the federal government. Unions representing healthcare workers, teachers, transit operators and millions more joined the environmental groups to sue the feds over their failure to provide adequate reusable respirators, N95 masks, gloves and other personal protective equipment (PPE) […]

Filed Under: Featured, Hospital Care, Legal News, Respiratory Tagged With: coronavirus, COVID-19, Dept. of Health & Human Services (HHS), U.S. Department of Homeland Security

How much could Operation Warp Speed change pharma, medtech distribution?

October 7, 2020 By Chris Newmarker

A top U.S. Department of Health and Human Services official used an appearance today at a virtual medtech conference to repeat the U.S. government’s astounding goal for its Operation Warp Speed program: start delivering 300 million doses of a safe, effective COVID-19 vaccine by January 2021. The project could revolutionize not only how pharmaceuticals are […]

Filed Under: Distribution, Featured, Pharmaceutical Tagged With: AdvaMed, Dept. of Health & Human Services (HHS), McKesson, Operation Warp Speed

HHS gives Vaxxas $22M to support vaccine patch tech

October 5, 2020 By Chris Newmarker

Vaxxas announced today that it has received a $22 million award from the Biomedical Advanced Research and Development Authority (BARDA) at U.S. HHS to support a clinical study involving the company’s vaccine-delivery patch. The money will mostly pay for a Phase 1 clinical study in which Vaxxas’ high-density micro-array patch (HD-MAP) delivering pandemic influenza vaccine to […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, Dept. of Health & Human Services (HHS), U.S. Biomedical Advanced Research and Development Authority (BARDA), Vaxxas

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