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The company has also received FDA-clearance for seven other software products that can detect suspected pathologies in computed tomography (CT) exams. Read More
The imaging software has already been used in multiple pilot locations for more than a year, processing more than 500,000 real-world chest X-ray images, the company said. Read More
The tonometer uploads glaucoma patients’ intraocular pressure data to the company’s cloud-based iCare Clinic, which sends it to healthcare professionals for review. Read More
The FDA has issued a Form 483 to device developer Medical Solutions International, based on an inspection last December of the company’s manufacturing facility in Shawnee Mission, Kan. Read More
DermaSensor’s optical spectroscopy device has demonstrated a 96 percent melanoma detection rate and a negative predictive value of 98.1 percent in a clinical trial, the company said. Read More
In an effort to address differing definitions of the term “digital biomarker” and improve discussions on medical product development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Read More
The interns may assist senior reviewers in obtaining and reviewing technical data and material related to device submissions, the agency said. Read More
The FDA has asked Congress to consider several proposed authorities that would affect medical device developers, manufacturers and distributors. Read More