Editor's note: This article has been updated with a quote from iCardio.ai CEO.
Los Angeles-based iCardio.ai has received FDA 510(k) clearance for its artificial intelligence software for interpretation of echocardiography, aimed at offering a comprehensive imaging workflow and autonomous preliminary reporting.
iCardio.ai develops machine learning and deep learning algorithms for the examination...
An over-the-counter continuous glucose monitoring (CGM) solution developed by Dexcom called Stelo has received clearance from the Food and Drug Administration (FDA).
Available without the need for a prescription, the wearable biosensor boasts a battery life of up to two weeks and adheres to the back of the upper arm.
The patch aids in the detection of normal (euglycemic) as well as low or high (...
Medical technology firm Hologic has been granted clearance from the FDA to market its Genius Digital Diagnostics System, powered by the company's Genius Cervical AI algorithm.
The digital cytology system – a medical diagnostic tool used to examine cells under a microscope to detect abnormalities or diseases – integrates deep learning-based AI with advanced volumetric imaging technology to aid in...
Swedish CE-certified birth control app, Natural Cycles has announced that it has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA).
The Natural Cycles app, is the first and only FDA cleared birth control app in the US.
WHY IT MATTERS
The purpose of the notification is to revise the labeling to expand the third-party thermometers, which include wearables...
23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing.
WHAT HAPPENED
This action updates a De Novo approval granted to the consumer genomics company in late 2018. That decision allowed 23andMe to market a test for one of 33...
Abbott has received FDA approval for a neuromodulation system-controller app that runs on iOS devices, the company announced Thursday.
Compatible with Abbott's broader NeuroSphere Digital Care platform, the Patient Controller app replaces the separate device patients use to adjust the company's neuromodulation products. These include the Infinity DBS System for Parkinson's disease or essential...
Today the remote and continuous-monitoring platform Vitls announced that it has received 510(k) clearance from the FDA.
The Vitls Platform uses a single wearable device called Tégo that records vital signs. The device itself is wireless and waterproof, and it has a battery life up to 6 days. It records body temperature, pulse, heart rate variability, respiration rate, oxygen saturation, sleep and...
Cochlear Limited announced yesterday the U.S. Food and Drug Administration clearance of three new products to be added to the company’s suite of hearing technology devices, all of which can connect to smartphones.
The Premarket Approval clearances went to the Kanso 2 Sound Processor, the Nucleus 7 Sound Processor for Nucleus 22 Implant recipients and the Custom Sound Pro fitting software. The new...
Women’s health company Proov got the FDA green light for its at-home ovulation testing kit.
Users can send away for the kit and get test strips, which can determine the presence of progesterone metabolite PdG in urine, which is linked to a woman's ovulation cycle.
The test was developed to help women find out if they are ovulating on a regular basis.
In the spring, the company will roll out...
Last week the FDA greenlighted the ultrasound app VistaScan from Emagine Solutions Technology.
The new software app can be used on a doctor's cellphone or tablet. It can also connect with companion ultrasound probes, which are already FDA cleared.
The company previously partnered with the Red Cross to assist women with prenatal scans, according to a video on the company’s website.
WHY IT...
