Tags : Clearance

Paige Receives the US FDA’s 510(k) Clearance for its FullFocus

Shots The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future In Nov’2019, FullFocus received the CE Mark, making it available to use in […]Read More

Hyperfine Research Receives the US FDA’s 510(k) Clearance for its

Shots: The US FDA has cleared the world’s first portable MRI system, designed to be wheeled to a hospital bedside for scanning a patient’s head and brain. The Hyperfine system is 20X lower cost, 35X lower power consumption, and 10X lower weight than conventional MRI systems The system is highly portable, can be controlled via […]Read More

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

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

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

Medtronic’s SelectSite C304-HIS Deflectable Catheter System Receives FDA’s Clearance for

Shots: Medtronic reports FDA’s clearance & launch of SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing The catheter system features a deflectable out-of-plane curve to reach bundle of His, accommodating challenging patient anatomies including patients with a large right atrium The SelectSite C304-HIS facilitates placement of the Medtronic’s SelectSecure MRI SureScan […]Read More

Roche’s Cobas TV/MG Test Receives FDA’s 510 (k) Clearance for

Shots: Roche has received 510(k) clearance for its Cobas TV/MG test runs on Cobas 6800/8800 System to detect Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients The addition of Cobas TV/MG test expands the testing menu on the Cobas 6800/8800 Systems and has been validated to use with multiple […]Read More