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Still Mulling EUA Transition Options? Don’t Wait Too Long, Attorney Says

 
• By Elizabeth Orr

Manufacturers whose COVID-19 related products reached market via the US FDA emergency use authorization pathway will soon face a choice as to whether to get additional clearances stay on the market or not. According to Alston and Bird attorney Ben Wolf, the time to prepare is now.

Clocks
• Source: Shutterstock: elwynn

An end to the COVID-19 public health emergency (PHE) may finally be in sight as the Omicron wave recedes and case counts drop across the country. Just a few days ago, 70 Republican members of the US Congress sent a letter to President Joe Biden and secretary of Health and Human Services Xavier Becerra asking the president not to renew the PHE, which will expire in mid-April if not re-upped.

But whenever the PHE ends, manufacturers that have brought regulated products to market through the emergency use authorization (EUA) process...

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FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

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Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.