Cognoa's AI platform for autism diagnosis gets first FDA stamp

Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism -- meaning the digital health startup is now positioned to submit an appl

FDA clears AliveCor’s Kardiaband as the first medical device accessory for the Apple Watch

The Food and Drug Administration has just cleared AliveCor’s Kardiaband EKG reader as the first medical device accessory for the Apple Watch. Europe has been able to use a version of the Kardiab

Peter Thiel backs offshore human testing of experimental herpes vaccine

Peter Thiel and a group of libertarians are funding an offshore human clinical trial of a herpes vaccine, skirting FDA regulations and sparking a heated debate over U.S. safety rules.

Omega Ophthalmics is an eye implant platform with the power of continuous AR

Google and other tech companies have come up with glasses and contact lenses for the purposes of AR, but Omega Ophthalmics is taking a much more invasive approach by using surgically implanted lenses

A year with the PAX Labs Juul vaporizer

Nicotine vaporizer companies have a bit of a conundrum. While, legally, they can’t market themselves as smoking cessation devices, most vapers are current or former cigarette smokers. In fact, t

9 promising at-home lab test startups for everything from fertility to STDs

It’s easier than ever to skip the doctor and go straight for the at-home test these days, thanks to updated regulations and the technology to match — and for many, it’s the answer to

FDA issues new security guidelines so that your pacemaker won’t get hacked

This week, the US Food and Drug Administration issued a set of recommendations for securing medical devices that could jeopardize the safety and privacy of their users. The report, titled “Postm

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&#821

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 t

Unpacking the innards of Theranos’s new Zika-detection box

Theranos has had a long 10 months. The company, beset with regulation issues, has faced a Congressional inquiry, possible criminal charges, lawsuits, a recall of test results from the past two years,

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 t

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

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 beco

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

Wireless Power And Battery Life Anxiety

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 in

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 t

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 a

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 re

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

I wore a calorie counter <a target="_blank" href="http://www.bodymedia.com/Support-Help/BodyMedia-FIT-Armbands">armband from BodyMedia</a> that told me I was burning over 3,000 calories a day. If that
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