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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
MichClone Associates, a medical device manufacturer in Troy, Mich., has received a seven-observation Form 483 from the FDA for deficiencies observed during an inspection late last year. Read More
Synchron’s Stentrode investigational brain-computer interface device has been found safe and effective in a small study of patients with paralysis caused by amyotrophic lateral sclerosis (ALS). Read More