Stroke treatment device from Israel’s BrainQ wins FDA ‘breakthrough status’
Only about 5% of victims in the US currently arrive at the hospital in time to benefit from currently approved treatments. BrainQ's AI-based device...
FDA greenlights Visby Medical’s single-use, portable PCR test for COVID-19
Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point...
First Case with HipInsight Augmented Reality for Joint Replacement
Surgical Planning Associates (SPA) today announced a major step forward in how surgery can be performed with the introduction of its HipInsight augmented reality (AR)...
ShiraTronics, Inc. receives FDA Breakthrough Device Designation for Chronic Migraine Neurostimulation
ShiraTronics, Inc. a privately held medical device company, announced that it has been granted a Breakthrough Device designation by the Center of Devices and...
Push-button blood collection device receives CE mark
Seventh Sense Biosystems, (7SBio), developers of a push-button blood collection device, has received CE mark approval from the European Commission for its TAP II...
First daytime treatment for obstructive sleep apnea receives De Novo authorization
The eXciteOSA strengthens tongue muscles through electrical stimulation and comes with a companion app for tracking and sharing progress.The FDA has granted De Novo...
Abbott receives CE mark for COVID-19 asymptomatic testing and self-swabbing
Abbott has received the CE mark for two new uses of its Panbio COVID-19 Ag Rapid Test Device for the detection of the SARS-CoV-2 virus:...
Aktiia receives CE mark for 24/7 blood pressure monitoring system
Aktiia has received a CE mark for its automated blood pressure monitoring system, which the company says is the first of its kind.The Class...
OrthoSpin Gains FDA Clearance for G2 System
OrthoSpin was granted FDA 510(k) clearance to market a next-generation robotic digitally-enabled external fixation system.The OrthoSpin G2 system is approved in Israel as well, and can...