As we take a look at the devices that received FDA clearance in 2016's third quarter, we're also considering that the last few months have been a time of change at the Food and Drug Administration, as regulators are beginning to make updates in their system to accomodate all the digital health tools we're seeing.
In June, the FDA offered up a draft guidance document designed to help medical...
At a congressional hearing on mobile medical apps today, experts from different sectors of the industry weighed in on the ways they think federal regulation needs to change to create a robust digital health industry while still protecting the safety and wellbeing of patients. The conversation spanned various regulatory bodies and federal programs including HIPAA, the FDA, the FTC, and Medicare.
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The very first demo on-stage at Apple's special event yesterday was presented by AirStrip Technologies co-founders Dr. Cameron Powell and Trey Moore. Powell and Moore showed how a doctor could use her Apple Watch to remotely monitor her patients -- in this case pregnant women in labor and delivery wards who are hooked up to fetal heart and contraction monitoring equipment. AirStrip also demo'd...
Sense4Baby, the maternal and fetal monitoring product developed by West Health and then acquired by AirStrip Technologies, has received a second FDA 510(k) clearance, which will allow pregnant mothers to perform non-stress tests in their homes. The technology was previously only cleared for use by providers in clinical settings.
The Sense4Baby offering is a packaged kit that includes the wearable...
Medical device giant Medtronic is in the final stages of acquiring peel-and-stick medical sensor company Corventis for north of $150 million, MobiHealthNews has learned. While neither company has publicly commented on the deal, it is expected to be officially announced some time in the next few weeks. (Update: I've heard conflicting reports from sources on the price of the deal since publishing...
Plano, Texas-based remote monitoring startup Vivify Health (formerly Intuitive Health) raised $3 million, according to an SEC filing. This brings Vivify Health's total announced funding to at least $6.4 million to date.
MobiHealthNews reached out to Vivify Health for comment, but the company was not able to respond before deadline.
Existing Vivify Health investors include Ascension Health...
PillPhone: One of the first patient-facing mobile apps to get FDA clearance.
Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn't.
After more than two years since the FDA first published its draft guidance on how it regulates...
Mobile patient monitoring company AirStrip has partnered with Samsung to make its AirStrip One mobility software available on Samsung tablets, which run Android and Windows 8.1 operating systems. Adding a native Android tablet completes the operating system trifecta for the company, which has long worked with Apple and announced a partnership with Microsoft in July.
"We're seeing more and more...
AirStrip ONE OB
The massive Catholic Health Initiatives health system, with 87 hospitals in 18 states, is ramping up its digital health efforts while also getting ready to establish a distinct business unit dedicated to what the Englewood, Colo.-based organization calls "virtual health services."
(Correction: The original version of this article incorrectly described the unit as a standalone...
Waltham, Massachusetts-based Alere acquired wireless remote patient monitoring company MedApps last summer for an undisclosed sum, but according to Alere's SEC filings, the most that Alere will potentially have to pay for MedApps – based on an undisclosed earn-out structure – is $22 million. The earn-out time period runs through mid-January 2015. MobiHealthNews broke the news of Alere's MedApps...
