MedTech News
.................... by Andrew Celentano
Distalmotion gets FDA nod to expand Dexter surgical robot indications to gynecology
Distalmotion announced today that it received FDA 510(k) clearance for its Dexter surgical robot in a range of gynecology procedures.
XRlabs Achieves World First in AI-Designed Implants for Conjoined Twin Separation
In partnership with Gemini Untwined, XRlabs’ Surgical Intelligence platform generated custom implants in seconds and enabled successful craniopagus twin separation
FiberSense Receives CE Mark for its New CGM System
FiberSense has announced that its Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017/745 as a Class IIb medical device. The system is intended for continuous monitoring of blood sugar levels and glucose trends in adults with diabetes.
AngioDynamics wins FDA IDE for feasibility study of NanoKnife in BPH
AngioDynamics (Nasdaq:ANGO) announced today that it received FDA investigational device exemption (IDE) to initiate the RELIEF study.
AMDI™ Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel
The AMDI™ Mini Respiratory Panel delivers RT-PCR results in under 10 minutes, enabling clinical action in the Time of Care™
Oculogica wins FDA clearance for 90-second concussion test
Oculogica announced earlier this month that it won FDA 510(k) clearance for the SNAP concussion test.
FDA clears Dexcom Stelo over-the-counter CGM for children
Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children.
SurGenTec gets FDA nod for lumbar facet fixation system
SurGenTec announced today that the FDA cleared its ION-L lumbar facet fixation system for degenerative disc disease (DDD).