food and drug administration

food and drug administration

The FDA launches first inquiry into medical iPhone app

venturebeat.com
The Food and Drug Administration (FDA) this week launched its first investigation into an unregulated mobile medical app. Medical diagnosis on-the-go offers a new opportunity for health entrepreneurs. But the FDA believes that patient safety is potentially at risk with some — but not all — of these apps. The agency...
The FDA launches first inquiry into medical iPhone app
Health app makers to feds: Dithering on regulation is stifling innovation

The Scanadu Scout's big breakthrough may actually be in in clinical trials

gigaom.com
When I was in college my friends would head on over to a company called PPD to play lab rat in medical trials in exchange for pay. They would spend a day or a week sequestered in rooms where they were monitored, poked, prodded and fed a regimen of bills...
The Scanadu Scout's big breakthrough may actually be in in clinical trials

Whistleblowers sue FDA over e-mail monitoring

venturebeat.com
The Food and Drug Administration is being accused of monitoring the personal e-mails of six employees who had previously reported inappropriate device approvals to Congress and the press. “Whistleblowers” are protected by law in order to ensure that employees feel comfortable reporting misconduct within an organization. People who raise...
Whistleblowers sue FDA over e-mail monitoring
AliveCor's EKG monitoring case for iPhone gets FDA approval

iPhone urinalysis app draws scrutiny from FDA

appleinsider.com
Biosense Technologies' uChek system turns Apple's iPhone into a capable urinalysis device, and now the Food and Drug Administration is saying that it may need to clear the medical app lest developers risk violating federal law.    ...
iPhone urinalysis app draws scrutiny from FDA

FDA Approves Treatment To Give Limited Vision To The Blind

www.fastcompany.com
The Argus II can give people with severe retinitis pigmentosa the ability to see shapes, movement. The Food and Drug Administration approved the Argus II, the organization announced today, the first approved artificial retina to give limited vision to people who are blind. The device uses a small camera...
FDA Approves Treatment To Give Limited Vision To The Blind

Hadoop meets healthcare in new partnership

gigaom.com
The Mount Sinai School of Medicine is about to get a lesson in big data thanks to Cloudera Chief Scientist Jeff Hammerbacher. He will be partnering with the school’s clinical and academic faculty to develop new methods and systems for analyzing data in a variety of important areas, including genomics...
Hadoop meets healthcare in new partnership

US regulator shuts down 1,677 Internet pharmacies

www.pcworld.com
More than 1,600 websites selling pharmaceutical products, including some spoofing CVS and Walgreens pharmacies, were shut down this week in a sting involving 99 countries, the U.S. Food and Drug Administration said Thursday.Close to 8,000 more were warned against selling unapproved drugs or those without a prescription. The FDA...
US regulator shuts down 1,677 Internet pharmacies
Solving China’s Food Safety Crisis, One App at a Time
Atlanta-based WebMD will layoff 14% of its workforce

Study: Many Skin Cancer-Detecting Apps Are Not Accurate

techcrunch.com
Dermatologists can rest assured that they will not be replaced by computers anytime soon. A new study finds that smartphone applications designed to automatically detect cancer lesions misdiagnosis more than half of all malignant growths. “There’s no substitute, at this point, for a complete skin exam performed by an expert...
Study: Many Skin Cancer-Detecting Apps Are Not Accurate

US FDA begins investigating smartphone medical apps

www.electronista.com
The US Food and Drug administration has begun investigating an iOS medical app available on the App Store to find out why it wasn't pre-approved by the agency and has begun the process of setting up guidelines for apps that make health- and medical-related claims. Currently, the agency only closely...
US FDA begins investigating smartphone medical apps
Comprehend wants to cure data woes for pharma companies

Entrepreneurs applaud Senate's backing of medical device tax repeal

venturebeat.com
The Senate has backed a repeal of a 2.3 percent tax on medical device makers that was enacted as part of Obamacare. Silicon Valley’s health-technology entrepreneurs view this move as a step in the right direction, whether or not the bill passes. “It could move forward and, more importantly...
Entrepreneurs applaud Senate's backing of medical device tax repeal
FDA approves the iStent, the smallest implant ever, for medical use

Bionic Eye Becomes a Reality

allthingsd.com
Regulators have approved a bionic eye for the first time in the U.S., saying Second Sight Medical Products Inc.’s retinal prosthesis can be used to treat a certain kind of blindness. The Food and Drug Administration approved the Argus II, which sends electrical stimulation to the retina to induce vision...
Bionic Eye Becomes a Reality

Your Genome, Your Data

www.techdirt.com
The computing revolution is not the only one driven by constant scaling of technologies: the field of genomics -- the study of DNA sequences -- has also enjoyed rapid falls in basic costs over the last decade and a half. This means that whereas the first human genome cost around...
Your Genome, Your Data

ARAIG is an exoskeleton suit that gives players instant feedback for every shot taken in-game

thenextweb.com
As Real As It Gets (ARAIG) is a new Kickstarter project that hopes to give players a more immersive and realistic video game experience by delivering sound and feedback through a multi-sensory bodysuit. The peripheral, spotted by Polygon, is equipped with 16 vibratory sensors across the torso, 16 on the...
ARAIG is an exoskeleton suit that gives players instant feedback for every shot taken in-game

US regulator shuts down 1,677 Internet pharmacies

www.computerworld.com
More than 1,600 websites selling pharmaceutical products, including some spoofing CVS and Walgreens pharmacies, were shut down this week in a sting involving 99 countries, the U.S. Food and Drug Administration said Thursday....
US regulator shuts down 1,677 Internet pharmacies

Should I use health apps?

www.guardian.co.uk
Some claim to cure acne, others that they can identify melanomas. But do the thousands of health apps for smartphone and tablets launched each year have any real medical benefits?There are more than 1,000 health smartphone/tablet apps released every month. You can use them to measure your mood, track your...
Should I use health apps?

Eucalyptus, Creator of Roll-Your-Own Cloud Platform, Raises $30 Million

allthingsd.com
Not everyone wants to run their applications on the public cloud. Their reasons can vary widely. Some companies don’t want the crown jewels of their intellectual property leaving the confines of their own premises. Some just like having things run on a server they can see and touch. But there’s...
Eucalyptus, Creator of Roll-Your-Own Cloud Platform, Raises $30 Million

FDA approves iRobot RP-VITA telepresence robot for use in hospitals

www.engadget.com
iRobot's robots physicians have been wanting to offer their diagnostic assistance for around six months, but now the the RP-VITA, made in partnership with InTouch's AVA telepresence broadcast tech, has been given permission by the FDA to roam a hospital corridor near you. According to the press release, the...
FDA approves iRobot RP-VITA telepresence robot for use in hospitals

FDA says your body is a “drug” and subject to gov’t regulation

www.slashgear.com
In what is perhaps one of the most controversial cases the Food and Drug Administration has ever participated in, there’s a new argument that’s making some pretty heavy waves. In essence, the FDA says that a person’s individual body can be categorized as a “drug” and is thus subject to...
FDA says your body is a “drug” and subject to gov’t regulation

F.D.A. Spied on E-Mails of Its Own Scientists

bits.blogs.nytimes.com
A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama. Read more »...
F.D.A. Spied on E-Mails of Its Own Scientists
Two-Factor Authentication Is For Wusses, Get A Tattoo

House lawmakers to examine regulation of medical apps

www.washingtonpost.com
House lawmakers said Tuesday that they will conduct a three-day series of hearings next week to look at how the Food and Drug Administration should regulate medical applications on smartphones and tablets. Lawmakers from the House Energy and Commerce committee will look specifically at how regulation affects patients, physicians and...
House lawmakers to examine regulation of medical apps

Here Come Caffeinated Cracker Jacks, Just in Time to Replace 5-Hour Energy

betabeat.com
ADULT SNACKS FOR ADULTS ONLY. Earlier this week, we received some rather alarming news about the tech world’s premiere hackathon fuel: The FDA is currently investigating a number of deaths tied to 5-Hour Energy. Yikes! Where can sleep-deprived coders and frazzled biz dev dudes turn now? One person can only...
Here Come Caffeinated Cracker Jacks, Just in Time to Replace 5-Hour Energy

US lawmakers ask if federal workers have email privacy

www.computerworld.com
Two Republican lawmakers have asked President Barack Obama's administration to investigate whether agencies are regularly monitoring federal workers' private email accounts after reports of the U.S. Food and Drug Administration firing employees over comments made in personal email messages....
US lawmakers ask if federal workers have email privacy

FCC working with startups, researchers to accelerate mHealth

gigaom.com
The MedMinder connected pill dispenser, powered by MedApps Trying to give the still nascent mHealth sector a motivational kick in the pants, the Federal Communications Commission has begun working directly with startups and universities to help bring new wireless telemedicine and healthcare technologies to market faster. On Wednesday, the FCC...
FCC working with startups, researchers to accelerate mHealth
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