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 […]
AdvaMed
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, […]
Medicare to cover breakthrough devices
FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices […]
Medtech takes a stand on D.C. rioting
The medtech industry has joined other business and industry groups in condemning Tuesday’s siege of the Capitol in Washington, D.C. by supporters of President Donald Trump. The National Manufacturers Association called for Vice President Mike Pence to invoke the 25th Amendment to remove President Donald Trump from office. The Business Roundtable tweeted a call for an end […]
How major medtech companies are responding to the looming EU MDR
Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once. The EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want […]
Joe Biden’s plan for COVID-19 and how the industry is reacting
Following the weekend’s news that Joe Biden is now president-elect of the U.S., plenty of focus is shifting to his plan for COVID-19. While positive news regarding Pfizer and BioNTech’s vaccine candidate came through this morning, the pandemic is still roaring on, with the U.S. hitting a record 128,000 new cases on Saturday as the […]
Advamed: Diagnostic COVID-19 tests shipments hit 200M
Total U.S. shipments of COVID-19 molecular diagnostic tests have reached 200 million, according to AdvaMed’s COVID-19 diagnostic supply registry. A breakdown of the data shows that diagnostics companies are shipping, on average, more than 1.4 million molecular tests each day. “For the past few months, our diagnostics companies have made it clear they’ll do whatever […]
DTW Podcast: Smith+Nephew’s Ortho president, Rhaeos’ big win and Medtronic’s legacy
In this week’s DeviceTalks Weekly Podcast, our opening and closing keynote interviews focus on executives from companies at very different stages. Manufacturing and sourcing Skip Kiil took the helm of Smith+Nephew’s (NYSE:SNN) global orthopedics business to transform it. The company’s recent acquisition of Integra LifeSciences’ (NSDQ:IART) extremities business will further that mission. In our closing keynote conversation, […]
The top 5 MassDevice stories of the week — October 9, 2020
Medtronic (NYSE:MDT) — the world’s largest medical device company — dominated the news on MassDevice this week. There were also some interesting insights to be had from AdvaMed’s The Virtual MedTech Conference. (Here’s to hoping a COVID-19 vaccine is widespread enough that it can be held in person next year.) Want to hear more about the […]
Medtronic CEO Geoff Martha: ‘I don’t want to go back to normal’
Even as the U.S. and the world struggle through the COVID-19 pandemic and resulting recession, Medtronic (NYSE:MDT) CEO Geoff Martha remains optimistic about the future. When asked today when things will return to normal for the medical device industry, the leader of the world’s largest medtech company quickly responded: “I don’t want to go back to […]
Avail grabs $100M to build OR telemed network
Avail Medsystems closed on $100 million for a Series B round to fund the company’s plan to provide free telemedicine equipment that can connect surgeons, interventional specialists and medical device sales reps. In an announcement issued this morning, Avail said the round was led by D1 Capital Partners, with participation from 8VC and existing investors. […]
