FDAnews Device Daily Bulletin

Medical devicemakers that don’t audit their products for computer security could be putting patients at risk, a cyber security expert says.

Shortcomings related to color coating processes and controls for Stingray Surgical Product’s forceps and other devices landed a Form 483 for the Florida-based company.

The Therapeutic Goods Administration welcomed the report by British experts, but said the number of Poly Implant Prosthese implants reported ruptured in Australia did not exceed that of any other brand of breast implant.

SpectraScience has signed an exclusive five-year agreement with PENTAX Europe GmbH to distribute its WavSTAT Optical Biopsy System for use in colorectal cancer screening and diagnosis.

Orlando, Fla.-based LensAR announced it has received 510(k) clearance from the U.S Food and Drug Administration for the company’s commercial cataract surgery laser system.

KFx Medical has announced it has received FDA 510(k) clearance for its 5mm AppianFx tissue fixation anchor.

Remote monitoring devices have been around for several years, though for the most part they’ve only been used at home by those with chronic illnesses to keep them safe and out of the hospital.

Aethlon Medical announced that the U.S. Patent and Trademark Office has given Aethlon a Notice of Allowance for U.S. Patent Application entitled “Extracorporeal Removal of Microvesicular Particles.”