Morning Read: FDA isn’t testing medical devices as much as they should, report says

A study of high risk medical devices by Yale School of Medicine researchers found that the 1 percent of devices that are studied before getting FDA approval are not being studied enough.


Longstanding critics of the U.S. Food and Drug Administration’s approach to testing medical devices got some fresh validation after a study by Yale School of Medicine researchers found that the 1 percent of devices that are studied before getting FDA approval are not being studied enough.

The study, which was published in the Journal of the American Medical Association, focused on 28 high risk devices such as stents and artificial hips. The researchers found that these devices are subjected to an average of just one major study apiece before being granted FDA approval. Dr. Joseph Ross, a professor at Yale School of Medicine and one of the authors of the paper said:

“The laws are written in a way to facilitate earlier access to therapy, because that’s what most lawmakers think their constituents want…But as a result, we don’t have the data we need to make the best decisions for our patients.”   — The Huffington Post


San Diego-based GlySens got approval from the FDA to extend clinical evaluation of its continuous glucose monitoring implant from six months to one year. GkySens CEO William Markle noted that all of the current clinical trial participants independently consented to be part of the study extension and keep their sensor implanted for twelve months. — PR Newswire


LUX Health Network has launched a concierge care business that includes primary care physicians and specialists.— BusinessWire


Healthcare biometrics industry is expected to generate $12.8 billion in revenue by 2024, according to a report by Tractica. — BusinessWire

Practice Fusion named a new CEO, Tom Langan, in the run-up to what’s expected to be its initial public offering. Ryan Howard, who founded the electronic health record provider, will become chairman.— VentureWire


Surprisingly, vaccinations are an emerging issue among Republicans in the presidential race. First Donald Trump’s tweet from 2014 repeating the disproven theory that childhood vaccines are connected to autism got a new life from critics. Then former Hewlett Packard CEO Carly Fiorina said she would support leaving it to parents to decide whether to inoculate their children against communicable diseases, although she later clarified that public schools were within their rights to turn children away if they were not inoculated. All of it prompted former New York governor George Pataki to tweet:

The Hill


Jeff Bezos responded to The New York Times’ damning article depicting miserable working conditions at his online retail giant Amazon with a memo to staffers. The CEO urged employees to email him or human resources if they face or witness the kind of humiliation described by former staffers in the article.

“I strongly believe that anyone working in a company that really is like the one described in the NYT would be crazy to stay. I know I would leave such a company.”

At least 0ne reader who commented on the post noted that if Bezos was really interested in confirming the truth behind the allegations, he would investigate it himself rather than letting his employees take on the risk.  — GeekWire

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