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 […]
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CMS delays breakthrough device Medicare coverage
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 […]
Biden to put $12B toward COVID testing
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 […]
MedTech 100 roundup: Industry rebounds from massive dip
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 […]
DTW Podcast: CEO Petrovic explains how Insulet is switching people to `Pods
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 […]
AdvaMed brass on Biden administration: So far, so good
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 […]
N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard
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 […]
Abiomed CEO Michael Minogue appointed as AdvaMed chairperson
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 […]
Feds to spend $1.6B to expand COVID testing, domestic manufacturing
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 […]
AdvaMed wants input on Biden pandemic DPA use
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 […]
Biden’s COVID-19 response will make manufacturers busy
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, […]
