February 22, 2021
Pulse oximeters, devices used for estimating blood oxygen levels, may be less accurate in people with darker skin pigmentation, the FDA warns. The tools are often used by patients at-home to monitor conditions, however the FDA cautioned that the technology have limitations and a risk of inaccuracy under certain conditions.
Today many pulse oximeters are digitally connected, which has made the...
September 28, 2020
Medical device creator Masimo announced today its latest 510(k) clearance from the U.S. Food and Drug Administration for the Rad-G pulse oximeter.
The Rad-G is a handheld device that combines Masimo’s signal extraction technology (SET) pulse oximetry and respiration rate from the pleth (RRp) that can be used to spot-check or continually monitor.
It’s lightweight, handheld, and has a 24-hour...
October 18, 2018
Mountain View, California-based Beddr has launched Sleep Tuner, its first health wearable. The device is an FDA-registered sleep sensor, worn on the forehead, which measures blood oxygenation, heart rate, and sleep position, as well as stopped breathing events.
“The device affixes to the forehead with a medical-grade adhesive, and the adhesive is changed each test night so it’s easy to apply and...
December 15, 2015
China-based Viatom Technologies has received FDA 510(k) clearance for Checkme Pro, a connected medical device that tracks a number of vital signs, according to Medgadget.
The small Checkme Pro device includes an ECG that tracks heart rate, QRS duration, ST segment, and rhythm analysis, a pulse oximeter, an activity tracker, a thermometer, and a sleep monitor. The device can be set to a hospital...
March 11, 2014
Toronto, Canada-based mobile health company LionsGate Technologies (LGTMedical) raised $2 million to develop and test its smartphone attached pulse oximeter, called Phone Oximeter, according to a press release. Vancouver-based Coleco Investments CEO Irfhan Rajani invested $1 million and Grand Challenges Canada awarded LionsGate a $1 million grant.
Phone Oximeter is a small device that attaches to...
January 16, 2014
Alere Connect, formerly known as MedApps before it was acquired by Alere, announced FDA clearance this week for its latest home health hub, HomeLink. The clearance rounds out Alere Connect's portfolio of hub devices to three main options: HomeLink, MobileLink, and HealthPAL. While each of the hub devices uses a cellular radio for backhaul -- no need to connect it via ethernet or your home WiFi...
November 20, 2013
Medical device maker Nonin showed off a new smartphone-connected product, a regional oximeter, at Medica in Dusseldorf, Germany.
Regional oximetry, also called cerebral oximetry or rSO2, is a form of continuous monitoring that measures the level of oxygen saturation in the brain or on other tissue. According to Nonin's description of its existing regional oximetry system, the technology can be...
October 7, 2013
iHealth's existing consumer pulse oximeter.
iHealth Labs, a subsidiary of China-based medical device company Andon Health, has received FDA clearance for a wireless fingertip pulse oximeter, which will be a distinct offering from the consumer pulse oximeter the company announced at CES last year and currently sells on its website.
"Basically we're coming out with an FDA-[cleared] version,"...
May 8, 2013
At the American Telemedicine Association in Austin Texas, Nonin showed off its newest product, the Nonin 3230 Bluetooth Smart-enabled pulse oximeter. The product is still awaiting FDA 510(K) clearance, but the product is on track to be the first wireless pulse oximeter to use the low energy communication protocol, also known as Bluetooth 4 or Bluetooth LE.
The device is worn on the fingertip with...
January 30, 2013
Cloud-based patient monitoring company Intuitive Health has raised $3.4 million, according to an SEC filing first spotted by the Dallas Business Journal. The company isn't yet willing to talk much more about the funding raise; CEO Eric Rock told MobiHealthNews in an email that they are still in stealth mode. This appears to be the company's first public funding raise.
Although the Plano, Texas-...