Good news for Sense4Baby, developer of an FDA-cleared portable wireless maternal/fetal heart rate monitoring system that works with smartphones and tablets.
The company just received 510(k) clearance and CE mark for commercializing the smartphone-based fetal monitoring system in the U.S. and Europe.
The solution, which is designed to perform non-stress testing (NST) for high-risk pregnancies on a smartphone or tablet, has made enormous strides in the short time it has been around.
Posted in mHealth news, Regulation, Smartphones, tablets, Technology
As anticipated for quite some time now, mobile health solutions company Happtique has finally announced the first batch of certifications for a small number of medical apps.
The certifications come through the company’s Health App Certification Program (HACP).
Happtique says this “inaugural class” is the first group of apps in the country to pass the rigorous HACP standards announced earlier this year.
Posted in mHealth, mHealth news, Mobile App, Organizations, Regulation, Smartphones
On the eve of Thanksgiving last week, the team at iPatientCare had much to be thankful for in the state of New York.
A pioneer in mHealth and cloud-based ambulatory EHR solutions, the company confirmed its successful certification of its EHR by the New York Immunization Information System and the New York Department of Health.
This achievement will allow iPatientCare users to both submit and import immunization data electronically and directly from iPatientCare EHR.
Posted in Healthcare, Hospitals, mHealth, Organizations, Patient privacy, Regulation, Technology
The FDA is in the middle of a disagreement with Congress. The issue at hand? mHealth regulation.
Specifically, the debate boils down to whether mobile health-related software should be regulated as a medical device would ordinarily be.
The debate was elevated to a new level this week during Tuesday’s hearing by the House Energy and Commerce Subcommittee on Health.
Posted in Healthcare, mHealth, mHealth news, Mobile App, Regulation
No World Borders, a health care consulting firm, confirmed to mHealthWatch today that company CEO Michael Arrigo is coming to Washington DC to speak about ICD-10, a new standard of reimbursement for the $3 trillion U.S. health care economy.
Arrigo will be presenting at the WEDI Fall 2013 conference, which is themed “The Health IT Tipping Point: Bridging Strategy & Execution” on Wednesday, November 20th, 2013.
We’re told that his presentation “will touch on clinical data, health care claims data, BigData, mHealth and cloud computing analytics that can be used to improve clinical documentation for ICD-10.”
Posted in Affordable Care Act (ACA), Healthcare, Healthcare IT, Organizations, Regulation, Technology
Sotera Wireless says it has received clearance from the U.S. Food and Drug Administration for the Company’s patented continuous non-invasive blood pressure (cNIBP) technology.
This particular technology is a new feature of the ViSi Mobile wireless patient monitoring system.
“For the first time,” the company says, “clinicians can continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the use of a catheter or blood pressure cuff.”
Posted in Healthcare, mHealth news, Regulation, Wearable technology
If you missed our live webinar last Thursday, you can now check out the informative presentation in its entirety online.
Along with our sister sites Mobile Marketing Watch and mGamingWatch, we hosted an emergency webinar for marketers and related professionals across numerous industries – including healthcare – who must urgently educate themselves on a wide array of emerging issues related to consumer privacy, location based services, and the Telephone Consumer Protection Act (TCPA).
Attorneys Ross Buntrock and Michael Hazzard of Arent Fox, Rip Gerber of Locaid, and Jared Reitzin and Darren Withers of mobileStorm participated in the discussion.
Posted in Best Practices, Healthcare, mHealth, Patient privacy, Regulation, Security, Smartphones, tablets, Technology