Theranos secures FDA waiver to take its blood tests out of the lab

By: Jonah Comstock | Jul 20, 2015        

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theranos androidPalo Alto-based novel blood test company Theranos was granted a waiver from the FDA allowing the company to offer its first FDA-cleared blood test, its herpes simplex 1 virus IgG (HSV IgG) test, outside of a lab setting. According to the company, it’s the first HSV test to receive the waiver, called a CLIA waiver (CLIA stands for the Clinical Laboratory Improvement Amendments of 1988).

The move is the first official step for Theranos moving into mobile health, as it allows the company’s low-cost portable blood tests to be administered in Theranos Wellness Centers and retail pharmacies.

“Receiving this CLIA Waiver is an important milestone in fulfilling Theranos’ mission to provide actionable information at the time it matters,” Elizabeth Holmes, founder and CEO of Theranos, said in a statement. “Having the ability to make our test and system more broadly available in a variety of settings is critical to our aspirations to contribute to public health, as we continually innovate to provide the best laboratory testing services in the world. The ability for individuals and their health care providers to receive test results in near real-time will play a pivotal role in bettering diagnostic and treatment decisions.”

A statement from the company also provides some additional details on what the clearance entails, including that it covers the usage of the system by “non-laboratory personnel”.

“FDA’s determination came after review, by multiple FDA divisions, of extensive data demonstrating that the test and underlying Theranos System perform at least as well in the field with non-laboratory personnel as by trained operators in a traditional laboratory setting,” the company wrote. “Specifically, the Theranos System has built in fault-tolerance to deal with conditions that otherwise would impact results and performance and mitigate errors associated with otherwise unpredictable environments. Theranos provided data demonstrating that certain conditions would not affect the integrity of results reported for its HSV-1 test, including temperature fluctuations, humidity, tilting, power fluctuations, contamination, and storage and shipping conditions, among other variables in samples and conditions.” Keep reading>>


Limelight Health raises $3M for mobile insurance quoting offering

By: Aditi Pai | Jul 20, 2015        

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QuotePadSan Francisco-based Limelight Health, which has developed a white-labeled health insurance quoting app, announced that it raised $3 million from MassMutual Ventures, the corporate venture capital arm of Massachusetts Mutual Life Insurance Company (MassMutual), and AXA Strategic Ventures. Accelerator Launchpad Digital Health, which was the lead investor in Limelight’s seed round, also contributed. This brings the company’s funding to $3.7 million to date.

Limelight Health’s app, called QuotePad, allows insurance agents to upload census data, personalize the app with their logo and colors, adjust employer contribution strategies in saved quotes to help clients make decisions, calculate subsidies, and view or email the member a list of all contracted health plan networks. The app launched in January.

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HTC postpones release of Grip, its activity tracking device

By: Aditi Pai | Jul 20, 2015        

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Under Armour Record

Under Armour Record

HTC has announced that it will postpone the launch of its activity tracker, called HTC Grip, which was first unveiled in March and projected to launch in the spring, according to CNET.

HTC Grip is the company’s first activity tracking wristworn wearable. The tracker is powered by Under Armour’s newly launched app, UA Record, which integrates data from other health apps and devices.

“Through our partnership with Under Armour, we have continued to refine our vision and approach to the health and fitness category,” HTC said in a statement. “Our goal is to offer best-in-class products for our customers and partners. After extensive wear testing and user feedback, we have decided to align Grip with the entire product portfolio for health and fitness launching later this year. This will be a state-of-the-art comprehensive portfolio of products for this category powered by UA Record. We are excited to launch this new comprehensive product suite and will share further details as we get closer to launch.”

HTC has taken all mentions to Grip off of its product pages. HTC explained on its website when it first announced the Grip that the waterproof device tracks speed, distance, calories burned for runs, bike rides, gym workouts, and sleep activity. The device also features a GPS radio so it can track speed, distance, and pace during a user’s workout even when the wearer does not bring their phone along, and the tracker will sync this data to the user’s smartphone when they get back.

HTC and Under Armour first announced their partnership at CES earlier this year. At the time, HTC said Under Armour designers, sports scientists, and athletes were working closely with HTC’s Connected Products business unit, as well as its design and engineering teams to create products for both professional and amateur athletes.

Blueprint’s 8th class tackles payments, HR, stress management

By: Jonah Comstock | Jul 20, 2015        

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psocraticNew York City-based Blueprint Health has announced its eighth class of startups. The addition of these eight companies brings the accelerator’s portfolio up to 68 companies total. According to Blueprint, 87 percent of the companies that have participated in its program are still in operation and 85 percent of those are generating revenue.

Blueprint is a member of TechStars’ Global Accelerator Network, and startups in the Blueprint Health accelerator receive $20,000, office space in SoHo, and $50,000 in perks including server space and legal counsel. Blueprint takes a 6 percent equity stake in exchange.

“As an entrepreneur, you must ask yourself if joining Blueprint Health is worth the equity,” the company writes on its recently re-vamped website. “If you think your company is worth $3 million to $5 million (typical seed round valuations), you have to believe that we can add $100,000 to $200,000 of value to your company. Having worked with 60 companies, we have proven an ability to help our companies acquire customers and accelerate their fundraising process. The majority of our alumni would state that the value we have added has been exponentially greater than the equity they gave up. Time is typically an early stage entrepreneur’s most limited resource and we help you move faster to your sales, fundraising and team development goals.” Keep reading>>

FDA, Google met to discuss use of search to find adverse drug reactions

By: Jonah Comstock | Jul 16, 2015        

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MedWatcher, a tool for adverse event reporting, that the FDA worked on with Epidemico.

MedWatcher, a tool for adverse event reporting, that the FDA worked on with Epidemico.

Google met with the FDA last month to discuss the possibility of the FDA using Google search data to learn about drug side effects, according to a report in Bloomberg, which spotted a public record of the meeting and secured additional information from an FDA spokesperson. The talk appears to have been an informal, early-stage discussion on a topic in which the FDA has shown a steady increase in interest in recent years.

The clinical drug trials that FDA requires are designed to detect and catalogue side effects, but they are prone to miss certain categories of adverse effects — ones that effect a small, specific subset of the population that wasn’t included in the trial group, or long-term effects that take a long time to surface, for instance. They also don’t always catch adverse interactions between drugs.

Currently, the FDA tries to catch the adverse event data that slips through the cracks in a number of ways including MedWatch, the FDA’s voluntary reporting system, and the Sentinel Initiative, which consists of partnerships with health insurers and electronic medical records to get access to their aggregated data sets. The agency also recently announced a partnership with PatientsLikeMe, to potentially introduce patient-generated data into that mix. Keep reading>>

St. Jude receives FDA 510(k) clearance for mobile-enabled spinal cord stimulation trial system

By: Aditi Pai | Jul 16, 2015        

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Invisible_Trial_EPG_ipadSt. Jude Medical has announced that it received FDA 510(k) clearance for the St. Jude Medical Invisible Trial System, which is a mobile-enabled discreet spinal cord stimulation (SCS) trial system.

Patients who need spinal cord stimulation therapy, which helps them manage chronic pain, can have small device implanted in their body. The implant connects to thin wires, called leads, which deliver low levels of electrical energy to mask or interrupt pain signals. This reduces the sensation of pain for the patient.

But, before receiving a permanently implanted SCS device, patients are first given a minimally invasive trial device to evaluate the therapy. This trial device, though, is often connected to controllers and bulky programming cables, which can disrupt the trial experience and may be a barrier to SCS therapy. Keep reading>>