Tags : Clearance

MedTech

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI

Shots: The US FDA has granted 510(k) clearance for CorticoMetrics’ AI-based software, THINQ, for MRI brain volumetric reporting. The software can provide radiologists & neurologists with quantitative to improve assessment of neurological disorders The software can automatically segment T1-weighted MRI brain image, providing volumetric measurements & visualisations of 30 critical brain structures and compares the […]Read More

MedTech

Baxter’s Homechoice Claria APD System Receives the US FDA’s 510

Shots: Baxter has received the FDA’s clearance for its APD system designed for home use, combining it with Sharesource that aims to help patients with kidney disease manage their care remotely The Homechoice Claria system was cleared for both adults and children. Its interface is available in 38 languages and features step-by-step, voice-activated instructions through […]Read More

MedTech

Biofourmis’ Biovitals Analytics Engine Receives FDA’s 510(k) Clearance for Ambulatory

Shots: The US FDA has approved machine learning and AI-based Biofourmis’ Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring  The approval follows the approval of its Rhythm Analytics platform, cloud-based software for automated interpretation of 15+ types of cardiac arrhythmias in May’2019. The approval establishes the AI-powered solution as the foundation for […]Read More

MedTech Regulatory

Profound Medical’s TULSA-PRO Receives the US FDA’s 510(k) Clearance for

Shots: The FDA’s 510 (k) clearance is based on TACT clinical study involves assessing of TULSA-PRO in 115 patients with biopsy-proven, organ-confined prostate cancer and has received primary treatment of whole-gland prostate ablation with sparing of the urethra and urinary sphincter across the US, Canada and Europe The TACT clinical study resulted in meeting its […]Read More

MedTech Regulatory

Allergan’s CoolTone Device Receives FDA’s Clearance to Strengthen, Tone and

Shots: CoolTone device penetrates the muscle layers and induces involuntary muscle contractions utilizing magnetic muscle stimulation, thus strengthening muscle fibers resulting in improved muscle conditioning CoolTone is considered to have 50% more magnetic intensity (expressed in Tesla) than other similar devices (1.35 T vs 0.9 T) at the point of contact with its expected availability […]Read More