ASX-listed ResApp Health has received the US Food and Drug Administration's 510(k) clearance for SleepCheckRx, its mobile sleep apnoea screening app.
Introduced two years ago, SleepCheck is an at-home test for adults who are at risk of moderate to severe obstructive sleep apnoea. It screens for the condition by analysing breathing and snore sounds recorded via phone.
It has been approved as a...
CardieX files 510(k) for dual blood pressure, arterial health monitor
Australia-listed health tech firm CardieX has filed a 510(k) premarket submission with the US Food and Drug Administration for its dual blood pressure and arterial health monitor.
Called the CONNEQT Pulse, the health monitor features CardieX's FDA-cleared SphygmoCor technology which measures central blood pressure to obtain...
Baby tech company Owlet has pulled its connected-sock wearables from the market following an October FDA warning letter that the company was out of regulatory compliance. The news, which was first spotted by Deseret News, comes less than a year after the company went public.
The sock in question was designed to track an infant’s heart rate, skin temperature, blood oxygenation and sleep data....
The Food and Drug Administration has granted AppliedVR De Novo clearance to market its EaseVRx virtual reality system to treat chronic lower back pain.
The prescription device includes a VR headset and controller plus a “Breathing Amplifier” that’s used to train the user in deep breathing. Patients can participate in 56 VR sessions that use cognitive behavioral therapy to treat pain. The...
The Food and Drug Administration is classifying the recall of the Ellume COVID-19 Home Test for giving false positive results as a Class I recall, the most serious type of recall.
The agency said the “use of these tests may cause serious adverse health consequences or death.” The false positives could delay diagnosis or treatment for another serious non-COVID-19 illness, further spread the virus...
UNO Tech enters Malaysia, brings clinic management system
Singaporean medical technology firm UNO Technologies has entered the Malaysian market through its partnership with local pharmaceutical upstart Aetos Pharma.
The company seeks to get a slice of the pie from the increasing investments into the country's public and private healthcare system. It notes that its startup and tech ecosystem is "...
This week SyncThink landed FDA clearance for its digital AI-backed system, called the EYE-SYNC, to be used as an Aid to Concussion or mild Traumatic Brain injury (mTBI) diagnosis.
The system includes a web-based platform and a virtual reality headset. Clinicians can input patient information and symptom inventories. The tool is able to conduct 60-second eye-tracking assessments and...
The Food and Drug Administration is warning that certain lots of the Ellume COVID-19 Home Test may be giving false positive results due to a manufacturing issue.
The agency said negative results don’t appear to be affected, and that it’s working with the company to assess its manufacturing checks and take steps to fix the error.
Ellume is asking customers to check if their tests are part of the...
Israeli imaging startup Nanox has landed FDA clearance for its single-source digital X-ray Nanox.ARC, the company announced today. Nanox came on the imaging scene pitching to lower costs and sell its system via a price-per-scan model.
The company’s system combines an in-hospital scanning device with a companion cloud software tool. The X-ray device, which just landed the single-source clearance,...
Oxford University spinoff Oxehealth has received an FDA De Novo clearance for software that can estimate pulse rate, heart rate, respiratory rate and breathing rate from a video camera signal.
Founded in 2012, the company has often likened its technology to that of a pulse oximeter, which detects minute visual changes in skin color to measure blood oxygen levels.
In this case, the Oxehealth Vital...
