fda

  • FDA finds flaws in Theranos’ Zika tests

    FDA finds flaws in Theranos’ Zika tests

    This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn’t welcome to provide it yet is Theranos. The beleaguered blood analysis startup has run afoul of the FDA, yet again, The Wall Street Journal reports. Specifically, regulators found that in… Read More

  • What the Fitbit lawsuit means for clinical researchers Crunch Network

    What the Fitbit lawsuit means for clinical researchers

    Fitbit is facing a class-action lawsuit regarding the accuracy of their heart-rate data, which have been shown to be inaccurate by a margin of up to 20 beats per minute. This news risks sending back to the drawing board many of us who have been experimenting with biotelemetry. Here we seek to present a balanced view of the state of these and other related issues, and chart a viable path forward. Read More

  • Metal 3D printing takes flight Crunch Network

    Metal 3D printing takes flight

    While many designers and engineers find success with 3D-printing parts in plastic for prototyping and low-volume production, producing parts out of metal using similar technology has recently led to the creation of some of the most exciting 3D-printed parts in memory. Read More

  • The growing pains of mobile health Crunch Network

    The growing pains of mobile health

    The mobile healthtech industry is exploding. There is an estimated $42 billion annual market for personalized medicine and a mad dash to come up with the “next big thing.” The tech world is built and rewarded on hockey-stick growth: The faster, the better. This culture collides with mobile health; “move fast and break things” is great for social media, but in medicine… Read More

  • Legal health isn’t easy for digital health companies Crunch Network

    Legal health isn’t easy for digital health companies

    With the recent announcement of the Apple CareKit, an open-source platform to simplify the development of healthcare apps for iOS devices, it appears that the digital health industry is primed to become even more robust in 2016. As the convergence of healthcare and technology continues, technology companies (and investors) are increasingly finding themselves lost in a thicket of unique… Read More

  • Bio
    The Evolution Of The Biohacking Ecosystem Crunch Network

    The Evolution Of The Biohacking Ecosystem

    Silicon Valley efforts in the biology and health domains have recently seen increased public interest because of the questions around the legitimacy of Theranos’ technology and medical claims and the recent FDA approvals for a number of 23andMe’s genetic screens. These data points are just two of the most visible examples of a broad ecosystem of companies and startups in Silicon… Read More

  • Wireless Power And Battery Life Anxiety Crunch Network

    Wireless Power And Battery Life Anxiety

    Battery life is one of the most vexing problems in mobile tech. Indeed, Smartphone users consistently rate battery life as their No. 1 gripe. Consumers want better batteries, not wearables. So Apple’s recent announcement isn’t that surprising: iOS 9 will have a Low Power mode, which could provide an extra three hours of battery life. But that doesn’t solve the battery… Read More

  • Scanadu Raises $35M Series B To Check Your Pee And Scan Your Vitals

    Scanadu Raises $35M Series B To Check Your Pee And Scan Your Vitals

    Scanadu, a health tech startup working on devices that can scan and upload medical-grade diagnostic tests to a smartphone, has raised $35 million in Series B financing. The round was led by Chinese investment firms Fosun International and Tencent Holdings Limited, with participation from China Broadband Capital and Iglobe Partners of Singapore, as well as previous investors Relay Ventures… Read More

  • We Asked Rock Health Founder Halle Tecco About The Future Of Digital Medicine

    Health technology is becoming a big topic in 2015. We’re seeing wearable technology that can automatically upload our health data to the cloud, cellphones are becoming tools to connect us to the doctor’s office, a Google moonshot project detects cancer on an app and 23andMe has received FDA approval for at least one genetic test of a rare disease. This is now a multi-billion… Read More

  • YC-Backed Notable Labs Provides Personalized Medical Testing For Brain Cancer Patients

    YC-Backed Notable Labs Provides Personalized Medical Testing For Brain Cancer Patients

    Matt de Silva was working as a hedge fund manager with Thiel Capital in the fall of 2013 when he got the news that his dad had brain cancer — specifically, a Glioblastoma Multiforme (GBM), which is an aggressive form of brain cancer. There are very few treatment options for this type of cancer. de Silva’s father was told he had about 3-6 months to live without chemo and… Read More

  • 23andMe Ceases Health-Focused Gene Testing, Still Offers Raw Genetic Data And Ancestry Reports

    23andMe Ceases Health-Focused Gene Testing, Still Offers Raw Genetic Data And Ancestry Reports

    After the Food and Drug Administration ordered that 23andMe suspend use of its at-home gene testing kits, based on the government organization’s belief that it constitutes a medical device and thus requires further examination and testing before it can be provided for sale. 23andMe followed up to that bombshell with the news that it would be working with the FDA to try to resolve the… Read More

  • If Inaccuracy Were Illegal, The Feds Would Have To Regulate Most Health Gadgets

    If Inaccuracy Were Illegal, The Feds Would Have To Regulate Most Health Gadgets

    I wore a calorie counter armband from BodyMedia that told me I was burning over 3,000 calories a day. If that were true, I would be emaciated enough to play Gollum in the next Lord Of The Rings sequel. The accuracy of consumer health gadgets varies widely, yet this hasn’t stopped the FDA from suspending popular genetic testing company 23andMe over concerns about the quality of their… Read More

  • Proposed Food Safety Laws A Boon For Clean Tech Companies

    Today, the senate voted to work on a bill called the FDA Food Safety Modernization Act that would, among other things, require food producers, facilities and distributors in the United States to evaluate hazards more rigorously, undergo more inspections each year and implement preventive measures to keep food pathogen-free. Green tech companies that could benefit from higher standards for… Read More

  • Is Gulf Seafood Safe To Eat? Feds' New Test Says Yes, Not Convincingly

    More than 9,000 square miles of U.S. federal Gulf waters are closed to commercial and recreational fishing today thanks to the BP oil spill. However, government offices today claimed that seafood from the Gulf is basically safe to consume, based on the results from their latest battery of tests. You gonna eat that? Companies responsible for the environmental disaster spilled about 5… Read More

  • Dear FDA, Gimme My iMac

    Today was supposed to be a joyous day in my apartment. As of yesterday, my new Apple iMac was to be delivered at some point this afternoon. But alas, it was not to be. But the reason why is a truly great WTF moment. Apparently, the U.S. Food and Drug Administration has to approve its delivery to me. Well, to be more specific, either the FDA or the Department of AG/PPQ has to approve it… Read More