MedTech News
Beckman Coulter receives FDA clearance for DxFlex Clinical Flow Cytometer
Beckman Coulter Life Sciences, a laboratory automation and innovation company, has received 510(k) clearance from the Food and Drug Administration (FDA) to distribute its DxFLEX Clinical Flow Cytometer in the United States.
SurGenTec wins FDA nod for hydrophilic synthetic bone graft
SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.
Shape-shifting ultrasound stickers detect post-surgical complications
First-of-its-kind device ‘tags’ an organ to monitor abnormal, life-threatening fluid leaks
Nanosurgical tool could be key to cancer breakthrough
A nanosurgical tool – about 500 times thinner than a human hair – could give insights into cancer treatment resistance that no other technology has been able to do, according to a new study.
Dexcom’s over-the-counter nod sets stage for broader CGM use
The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.
MIT scientists use a new type of nanoparticle to make vaccines more powerful
Study shows metal-organic particles can both deliver vaccines and act as an adjuvant to generate a strong immune response at a lower dose.
RDS granted CE mark for MultiSense remote monitoring wearable
RDS, the medical device start-up, has been granted the CE mark for MultiSense, its patented, wearable solution for continuous Remote Patient Monitoring.
FDA clears first over-the-counter CGM from Dexcom
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription.