Tag Index  /  Showing 1 - 14 of 14 results for “FDA”

Government Healthcare

FDA Greenlights 23andMe and Opens New Era for Consumer DNA Info

It was a much-needed breakthrough when the FDA last week OK'd personal genomics company 23andMe selling genetic tests directly to consumers. In 2013 the agency had banned the startup from releasing disease-related information. Now we should finally see a consumer-driven marketplace for genomic data.   More

Bio & Life Sciences Business

Can Hot Consumer Genomics Startup Helix Keep the FDA at Bay?

A new company launched by the market leader in DNA sequencing aims to bring genomics to the masses. Helix, kicked off on August 18 with a capital injection of more than $100 million, appears to embrace a direct-to-consumer approach that hasn’t been seen since pioneer 23andMe's ready-to-mail spit kits. Given the FDA’s firm pushback against 23andMe, though, does Helix has a bright future?   More

Bio & Life Sciences Healthcare Opinion

Obama’s Not-So-Daring Precision Medicine Plan

For all the attention that President Obama’s precision medicine initiative has garnered in the weeks since he first mentioned it in his State of the Union address, you’d think the program was the next version of the Human Genome Project. But unlike that effort, which was a wildly audacious push to revolutionize biology and medicine, the modest new initiative—and its $215 million price tag—seems downright underwhelming.   More

Bio & Life Sciences Healthcare

Are 23andMe Customers Suckers or Empowered Consumers?

Direct-to-consumer genomics company 23andMe announced two research partnerships with pharmaceutical companies earlier this month. Since then, a lot of pundits have sounded positively appalled by the development. It reminds me of that great scene in "Casablanca" when Captain Renault says, “I’m shocked—shocked—to find that gambling is going on in here!” as he collects his own winnings.   More

Healthcare

FDA Proposal Could Limit Custom Tests for Patients

There’s a battle brewing between hospital labs and the FDA, and caught in the crosshairs are patients—the one group both sides say they are trying to help. At issue is how these labs are regulated, which has major implications for how quickly they can respond to new health problems, such as viral outbreaks.   More

Bio & Life Sciences Techonomy Events

Innovating Tools for Quantifying the Self, and Future Self

The quantified-self movement is rapidly moving beyond the Fitbit. Forget about wristbands to measure your vitals. DIYers known as Grinders are embedding electronics in their own bodies; transcranial direct-current stimulation experimentalists are putting wet sponges on their heads to improve cognitive function; and others, hoping to enhance their relationships with pets, are investing millions into developing EEG headsets that let them read dog thoughts. Eri Gentry, Carlos Olguin, and Drew Purves, all innovators at the fore of the field, joined WIRED writer Marcus Wohlsen at Techonomy 2014 on Monday for a conversation exploring what we mean when we talk about "innovating ourselves."   More

Healthcare

This Social Medicine App Helps Doctors Find Cures Together

Medical professionals are increasingly embracing mobile apps. They enable patients to track and share their metrics with doctors, and let caregivers monitor treatments and guide patients following surgery or other procedures. Now an app released earlier this year targets the core function of doctors—helping them diagnose and treat diseases.   More

Bio & Life Sciences

Talking to “Biologist’s Imagination” Author William Hoffman

In a new book called "The Biologist’s Imagination," authors William Hoffman and Leo Furcht from the University of Minnesota Medical School take a spin through the history of biological innovation in an effort to shed light on current trends and expected future developments. The authors weave historical threads—such as pioneering studies of genetic traits in the mid-19th century and the effects of the animals and diseases brought to the Americas in the wake of Columbus crossing the Atlantic—to help readers make sense of what’s happening today.The book covers a number of topics relevant to Techonomy, so we chatted with Hoffman to find out more.   More

Bio & Life Sciences

How You Are Hurt by FDA Genetic Test Restrictions

These are boom times for progress in genetic testing, but restrictions limiting access are delaying benefits we could all be experiencing right now. The National Institutes of Health maintains a Genetic Testing Registry, which currently lists some 15,000 available genetic tests. Together, they can single out 2,800 genes for some 4,000 medical conditions—and that’s not factoring in the rapidly growing exome or genome sequencing tests that look at all known genes. With so many tests out there, there’s a good chance that one exists to scan for whatever diseases may run in your family. But you may not be able to get those tests. Direct consumer access has always been tricky in U.S. medicine, and the FDA’s crackdown on consumer genetic testing firm 23andMe last year has providers running scared.   More

Bio & Life Sciences Healthcare

FDA Approves Medical Device for Reversing Opioid Overdose

When mobster wife Mrs. Mia Wallace overdoses on heroin, hit man Vincent Vega brings her screaming out of a comatose state by jabbing an adrenaline-filled syringe into her heart. Had the talking medical device that the FDA gave fast-track approval to last week existed 20 years ago, that Pulp Fiction scene between Uma Thurman and John Travolta might not have been so dramatic. The new pocket-sized naloxone hydrochloride auto-injector, called Evzio, coaches a user through the procedure of administering the opioid-O.D.-reversing drug into a victim's muscle.   More

Bio & Life Sciences

Will Doctors Finally Accept Technology? Yes. Here’s How.

In 1968, the American health economist Victor R. Fuchs wrote in the New England Journal of Medicine: “Medical tradition emphasizes giving the best care that is technically possible; the only legitimate and explicitly recognized constraint is the state of the art.” Nearly half a century later his words still ring true. But the medical profession is often slow to adopt the state of the art. Witness the industry’s slow uptake of innovations such as telemedicine and electronic medical records. The 2009 Health Information Technology for Economic and Clinical Health Act created financial incentives and penalties to encourage health care providers to implement electronic records by 2015. Still, providers are lagging.   More

Bio & Life Sciences Business Internet of Things Security & Privacy

People, Companies, and Trends: Techonomy’s 2013 Top Ten

As 2013 winds down, Techonomy takes a moment to look back on highlights from the year, especially those that portend—we think—the future. Our Top Ten list recognizes the people, companies, and ideas that embodied how technology is catalyzing change in business and society. Some of the individuals and organizations here were represented at our 2013 conferences, labs, and dinners, where we convene leaders to explore the biggest tech-driven challenges and opportunities. Some were featured in our expanding online editorial content.   More

Bio & Life Sciences Business

FDA Tells 23andMe to Stop Selling DNA Tests

Citing concerns "about the public health consequences of inaccurate results" from its Personal Genome Service, the FDA on Friday told 23andMe CEO Ann Wojcicki in a stern Warning Letter that her company must "immediately discontinue marketing" the service "until such time as it receives FDA marketing authorization for the device." The Twittersphere responded with shock and some outrage.   More

Bio & Life Sciences

Why Drug Development is Failing – and How to Fix It

The information technology industry has been living by Moore’s Law ever since 1965, when Intel co-founder Gordon Moore came up with the rule of thumb that the number of integrated circuits that can be placed inexpensively on an integrated circuit doubles every 18 months to two years. Contrast this with pharmaceuticals. In a paper published in a recent issue of Nature Reviews Drug Discovery, a wholly different development trajectory was posited, named “Eroom’s Law” (Moore’s Law spelled backwards): the cost of developing a new drug roughly doubles every nine years.   More