Nov 27, 2018

A reckoning for the medical device industry

A pacemaker seen in an x-ray. Photo: BSIP/UIG via Getty Images

The push for safer medical devices has been bubbling for years, and now the FDA may finally take a more critical stance toward the industry.

Driving the news: One day after a wide-ranging investigation — led by the International Consortium of Investigative Journalists and dozens of other media outlets — highlighted how breast implants, heart valves and other devices have harmed people due to lax or nonexistent safety standards, the FDA said it would change how some products get cleared for sale.

  • Many companies push their products through an approval process called 510(k) — a middle ground between life-saving devices and basic equipment that poses no harm.
  • 4 out of 5 devices get cleared through 510(k), in which they have to show they are “substantially equivalent” to older devices that are already on the market.
  • But the FDA is proposing to require newer devices to “be compared to the benefits and risks of more modern technology” — specifically, to a device that is no more than 10 years old.

The other side: The industry’s trade group, AdvaMed, criticized the ICIJ series as one-sided and raised concerns that the FDA’s 10-year cutoff period for most devices “could prove arbitrary.”

The bottom line: The FDA’s plans for more rigorous clearance standards won’t eliminate every loophole. However, the agency is publicly recognizing that many manufacturers have sold new products with minimal clinical testing, and that is a bar that may be too low for patient safety.

Go deeper: Exporting dangerous medical devices

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Trump's big, empty beef with Twitter

Illustration: Aïda Amer/Axios

President Trump finally acted on his now year-old threat to take action against social media platforms for alleged bias against conservatives. But so far, according to experts in both government and the industry, the threat looks mostly empty.

Driving the news: Trump escalated his war on Twitter Friday morning, tweeting repeatedly that the company needs to be regulated after it overnight added a warning label to a tweet of his calling for the military to start shooting looters, which violated Twitter’s rules against glorifying violence.

In photos: Protests over George Floyd's death grip Minneapolis

The Third Police Precinct burns in Minneapolis on Thursday night. Photo: Stephen Maturen/Getty Images

Demonstrators demanding justice burned a Minneapolis police station and took control of the streets around it last night, heaving wood onto the flames, kicking down poles with surveillance cameras and torching surrounding stores.

What's happening: The crowd was protesting the death of George Floyd, an unarmed black man whose life was snuffed out Tuesday by a white Minneapolis police officer who kneeled on his neck for about eight minutes.

Minneapolis mayor to Trump: “Weakness is pointing your finger” during a crisis

Minneapolis Mayor Jacob Frey fired back at President Trump on Friday, after the president accused the mayor of weak leadership amid violence sparked by the killing of an unarmed black man by a white police officer.

Driving the news: Trump made his accusations in a pair of tweets early Friday, saying he would bring the national guard into Minneapolis if Frey couldn't “bring the City under control.”