FDA wireless health

By  Brian Dolan 01:06 am April 26, 2012
This past December the FDA cleared DuoFertility, a basal body temperature thermometer sensor developed by Cambridge Temperature Concepts. The device, which is intended for use in measuring and recording basal body temperature as an aid in ovulation prediction to aid in conception, has been available in the UK for some time but only became commercially available in the United States this week....
By  Brian Dolan 07:42 am December 15, 2010
The US Food and Drug Administration (FDA) has granted 510(k) regulatory clearance to the Curvus Arrhythmia Monitoring Device (C-AD), a wireless-enabled and continuous tracker of real-time ECG readings. Curvus is a subsidiary of WPR Medical, which is based in Norway. C-AD will enter the market where a handful of other wireless cardiac monitoring companies are already playing: CardioNet, LifeWatch...
By  Brian Dolan 06:21 pm November 3, 2010
GE Healthcare announced that its Carescape B650 monitor secured FDA clearance this week. The monitor offers data integration and connectivity, consistency between care areas and -- mobility. "The monitor can run via a wireless local area network and can be battery operated, reducing the need for wall cables. The CARESCAPE Monitor B650 continuously transmits data to the central station, even when...
By  Brian Dolan 03:19 pm November 3, 2010
Two months ago Calgary Scientific announced that Health Canada had cleared its ResolutionMD Mobile app, which enables doctors to securely access high quality medical images from an iPhone or Android smartphone. This week the Mayo Clinic in Arizona announced it was using ResolutionMD Mobile to connect its neurologists with others working in seven remote hospitals. “One of the huge benefits is that...
By  Brian Dolan 09:28 am October 12, 2010
AT&T has inked a deal with eCardio Diagnostics to provide wireless connectivity to the arrhythmia monitoring company's near real-time cardiac monitoring devices. eCardio’s monitoring devices enable heart patients to recover at home rather than spend additional time in the hospital and aim to help reduce re-admissions among heart patients. According to the companies' release, "eCardio has...
By  Brian Dolan 04:41 pm September 1, 2010
Déjà vu all over again? Alere Health, formerly known as Inverness Medical Innovations inked a distribution deal with a wireless remote fetal monitoring company. In March Alere signed on to promote UK-based Monica Healthcare's wireless fetal monitoring system. This week, it's AirStripOB. AirStrip Technologies, which is known for having one of the very first FDA approved iPhone apps (AirStripOB),...
By  Brian Dolan 04:15 am August 2, 2010
To date, WellDoc's DiabetesManager is one of the few mobile health apps to have gone through an RCT. The United States Food and Drug Administration (FDA) has granted WellDoc 510(k) clearance to market its WellDoc DiabetesManager System to care providers and adult patients with type 2 diabetes. Next: WellDoc plans to commercially launch the WellDoc DiabetesManager System in early 2011. Five years...
By  Brian Dolan 01:47 pm July 27, 2010
The FCC's Director of Healthcare Dr. Mohit Kaushal posted a video tour of the wireless health companies exhibiting at the FDA-FCC wireless health meeting today and tomorrow. Watch as FCC Chairman Julius Genachowski, FDA Commissioner Peggy Hamburg and Federal Chief Technology Officer Annesh Chopra meet with a few of the 25 companies at the event. Lots of recognizable faces from the industry:
By  Brian Dolan 01:09 pm July 7, 2010
Honolulu, Hawaii-based Kai Medical received 510(k) clearance from the Food and Drug Administration to market an updated version of its wireless respiratory rate monitor, Noncontact Respiratory Spot Rate Check 200. Kai claims that currently approaches for measuring respiratory rate are difficult, which leads this vital sign to be inaccurately measured, infrequently measured or inconsistently...