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AdvaMed

AdvaMed launches medtech podcast

April 19, 2021 By Nancy Crotti Leave a Comment

AdvaMed today announced the launch of a new podcast, MedTech POV. AdvaMed president and CEO Scott Whitaker hosts the podcast, which covers the intersection of medtech and policy from a variety of perspectives. Each episode will feature discussions with medtech and healthcare policy leaders on issues that are driving the day — from business to […]

Filed Under: Business/Financial News Tagged With: AdvaMed

CMS delays breakthrough device Medicare coverage

March 19, 2021 By Nancy Crotti

Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule in January granting coverage for breakthrough devices the same day as their FDA approvals. The rule was supposed to take effect March 12, but CMS has postponed the Medicare Coverage of […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: AdvaMed, Centers for Medicare and Medicaid Services (CMS), FDA, Medical Device Manufacturers Association

Biden to put $12B toward COVID testing

March 17, 2021 By Nancy Crotti

The Biden administration today pledged $10 billion for school COVID-19 screenings and $2.25 billion for screenings and diagnostic testing among underserved populations. The money is part of the $1.9 trillion American Rescue Plan Act that Biden signed into law last week. The Department of Health and Human Services will divvy up the $10 billion among […]

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

MedTech 100 roundup: Industry rebounds from massive dip

March 15, 2021 By Sean Whooley

The medtech industry saw its largest fall in several months last week, but it has rebounded slightly after a couple of bad weeks. A strong start to 2021 hit a skid at the end of February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had […]

Filed Under: Business/Financial News, Featured, Funding Roundup, MassDevice Earnings Roundup, Mergers & Acquisitions, Wall Street Beat Tagged With: Abbott, AdvaMed, Asensus Surgical, Boston Scientific, Cardinal Health, Johnson & Johnson, MedTech 100 Index, PerkinElmer Inc., Takeda Pharmaceuticals

DTW Podcast: CEO Petrovic explains how Insulet is switching people to `Pods

March 14, 2021 By Tom Salemi

Insulet CEO Shacey Petrovic says she didn’t jump immediately at the chance to join the company. In an interview with the DeviceTalks Weekly Podcast, Petrovic, who was serving as CEO of a women’s health company when CEO-Patrick Sullivan, her former boss at Cytyc, called her with an offer to serve as Insulet’s chief commercial officer […]

Filed Under: Device Talks Podcasts, Diabetes, Drug-Device Combinations, Featured, Special Content Tagged With: Abbott, Adaptive Biotechnologies, AdvaMed, Baxter, Boston Scientific, Calumeo, DeviceTalks Weekly, Dexcom, Insulet

AdvaMed brass on Biden administration: So far, so good

March 12, 2021 By Nancy Crotti

In office barely two months, the Biden administration is winning high praise from leaders of the medtech trade group AdvaMed. That applies to the new administration’s use of the Defense Production Act for COVID supplies to its deliberation in choosing someone to lead the FDA. It doesn’t hurt that the $1.9 trillion pandemic relief bill […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: AdvaMed, coronavirus, COVID-19, FDA, Joe Biden

N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard

March 3, 2021 By Nancy Crotti

A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s  (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard. In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Legal News, Product Liability, Regulatory/Compliance, Women's Health Tagged With: AdvaMed, becton dickinson, C.R. Bard, Ethicon, Johnson & Johnson, pelvic mesh

Abiomed CEO Michael Minogue appointed as AdvaMed chairperson

February 23, 2021 By Danielle Kirsh

Medtech trade group AdvaMed today said it has appointed Abiomed (NSDQ:ABMD) president and CEO Michael Minogue as chairperson of the AdvaMed board of directors, effective immediately. Minogue will serve as chairperson of the trade association’s board of directors for two years. He has been a member of the board since 2007 and a member of the […]

Filed Under: Business/Financial News Tagged With: Abiomed, AdvaMed

Feds to spend $1.6B to expand COVID testing, domestic manufacturing

February 17, 2021 By Nancy Crotti

The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants. The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such […]

Filed Under: Business/Financial News, Diagnostics, Featured, Lab Instruments & Supplies Tagged With: AdvaMed, coronavirus, COVID-19, COVID-19 variants, Dept. of Health & Human Services (HHS), U.S. Centers for Disease Control and Prevention (CDC), U.S. Department of Defense

AdvaMed wants input on Biden pandemic DPA use

January 25, 2021 By Nancy Crotti

AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words. In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump. Get the full story […]

Filed Under: Business/Financial News, Diagnostics, Featured Tagged With: AdvaMed, coronavirus, COVID-19, supply chain

Biden’s COVID-19 response will make manufacturers busy

January 21, 2021 By Nancy Crotti

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic. In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, […]

Filed Under: Business/Financial News, Diagnostics, Distribution, Drug-Device Combinations, Featured, Medical Device Manufacturers Assn. (MDMA) Tagged With: 3m, AdvaMed, BD, becton dickinson, International Safety Equipment Association, Medical Device Manufacturers Association, Medline Industries Inc., PPE

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