GE HealthCare announced that its Brazil-based partner Ionic Health received FDA 510(k) clearance for its nCommand Lite, which provides diagnostic imaging centers with real-time scanning, remote guidance and operational support, and the ability to view/review images remotely.
Ionic’s software interacts with equipment like a local technician, enabling remote operation of MRI, CT and PET scans with...
Nesa obtains US FDA 510(k) for fibroid mapping tech
Indian femtech Nesa Medtech has received the United States Food and Drug Administration 510(k) clearance for its fibroid mapping tool.
Its Fibroid Mapping Reviewer Application assists in the diagnosis and planning of interventional procedures for patients with uterine fibroids. It generates a 3D model of the uterus from ultrasound images where...
Respiree, a med tech spinoff of Singapore's Agency for Science, Technology and Research, has obtained the United States Food and Drug Administration's 510(k) clearance for its wearable cardio-respiratory sensor device.
The RS001 device directly measures respiration in patients dealing with cardio-pulmonary diseases such as COPD and congestive heart failure.
It is part of Respiree's iRIS...
Tasso received FDA 510(k) clearance for its patch-like blood collection device, the Tasso+.
The device includes a lancet, which adheres to the arm, that connects to a test tube for collection. After users rub their arm or use a heat pack and sanitize the test site, they press a button on the front of the device to begin drawing capillary blood. Then the tube can be removed and sent to a lab for...
Bodyport announced it has received the FDA green light for its connected scale that remotely monitors patients with fluid management conditions such as heart failure and kidney disease.
The Cardiac Scale, which is intended for people 21 and over who weigh less than 397 pounds, can be used to track body weight, pulse rate, center of pressure and peripheral impedance, which can signal changes in...
Smart stethoscope company Eko last week announced it has received FDA 510(k) clearance for an algorithm that detects and characterizes heart murmurs in adult and pediatric patients.
Eko Murmur Analysis Software, which officially received the green light in late June, is a machine learning algorithm that uses heart sounds, phonocardiograms and ECG signals (when available) to detect murmurs and...
LiveMetric announced it has received FDA 510(k) clearance for its watch-like blood pressure monitor, LiveOne.
The cuffless device uses a sensor array placed over the radial artery to produce a pressure waveform. The waveform is then analyzed by an algorithm to determine systolic and diastolic blood pressure and pulse rate. According to the FDA's 510(k) database, LiveOne is intended to be used in...
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...
Brain data startup Rune Labs announced Tuesday it received FDA 510(k) clearance to use its StrivePD app to monitor Parkinson's disease patients' symptoms through the Apple Watch.
The StrivePD system uses Apple's Movement Disorder API to track tremors and dyskinesia, or uncontrolled, involuntary body movement. Patients can also use the app to log their medications, side effects and other symptoms...
EarliTec Diagnostics announced it has received FDA 510(k) clearance for a device that helps clinicians identify autism spectrum disorder for children between the ages of 16 and 30 months old.
The tool, called EarliPoint Evaluation, uses eye-tracking technology to monitor a child's looking behavior while they watch short videos of other children interacting with one another. The technology...
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