AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k)...
Respira Labs recently announced that it has developed a wearable device that continuously assesses lung function without the need for traditional pulmonary function tests.
Mountain...
The InVisionOS officially received the clearance earlier this month and will be available in early 2022.
PrecisionOS scored FDA 510(k) clearance for its InVisionOS tool that...
New 510(k) clearance expands the use of MammoScreen® from 2D to 3D mammography, opening up the entire breast cancer screening market
Therapixel, a company leading...
Strados Labs, a medical technology company using smart sensors to aid in early detection and predictions of worsening diseases for enhanced patient care, has been...
iSTAR Medical, a medtech company developing novel minimally-invasive implants for glaucoma surgery (MIGS), has seen its MIGS device, MINIject approved in Europe for open-angle glaucoma patients.
Glaucoma...
The US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Blackrock Neurotech’s MoveAgain Brain Computer Interface (BCI) System.
The system has been...
Nearly two decades after its NeuroPort Array scored the FDA’s first approval for an implanted electrode panel that sends brain signals to a computer...
Cardialen has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to begin a clinical trial of...
