In a bid for regulatory convergence with other international regulators, the FDA announced it is looking for companies to participate in a pilot program involving the use of a common international format for regulatory submissions like 510(k)s and PMAs.
New medical devices for rectal cancer surgeries are helping patients forgo colostomies, shifting more individuals toward a new procedure that requires fewer external adjustments, according to medical experts.
A team of researchers has developed a “blood clot probe” for finding the precursor of stroke and heart attack using positron emission tomography. The method worked–at least on rats.
Owlet Baby Care has expanded its Series A round by $6 million. It also picked up another $1 million in a National Institutes of Health (NIH) grant–to bring its fundraising total to $9.2 million. The startup will use that cash for a fall launch of its Owlet Baby Monitor that is intended to alert parents via smartphone if their baby stops breathing.
A study by two psychologists at Germany’s Max Planck Institute on Human Development poured cold water on the use of brain electrical stimulation techniques, lending support to those who dismiss the methods of supposedly improving memory and mood as pseudoscience.
Amid growing evidence that mammography alone is not sufficient in screening women with dense breast tissue for breast cancer, a new Mayo Clinic study shows that adding an innovative molecular breast imaging solution to traditional mammography could be more accurate and cost-effective.
The FDA said international standards were insufficient, and put forth a stricter standard in order to ensure that intraocular lenses and other intraocular ophthalmic devices are free of bacteria upon manufacturing.
A new fetal electrocardiogram (ECG) technology designed to be used along with conventional fetal heart rate monitoring contributes little benefit in reducing complications during childbirth, according to a study by the National Institutes of Health.
The FDA touted faster approval times in a report on policies and initiatives at its device arm (CDRH). In addition, the agency outlined some of its new regulatory initiatives.
If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.