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Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and will “need to learn to speak the language for both sides of the combination product,” according to a former FDA official. Read More
Israel-based Ibex Medical Analytics has partnered with Milan, Italy-based Dedalus to supply software products to help pathology labs “maintain high accuracy diagnosis levels and reduce diagnosis times.” Read More
The software also highlights nonpathological details, such as discrepancies at the margin of existing restorations, crowns, fillings, root canals, bridges and implants. Read More
The affected software could cause users to “inadvertently program and confirm a basal rate with an incorrectly placed decimal point,” which could lead to an underdose or overdose of insulin, the company said. Read More
The fault carries a danger of serious adverse events, such as arterial or rupture, ischemia and/or blood vessel complications that could require surgical repair. Read More
A majority of “smart” infusion pumps are vulnerable to hacking, in many cases because of software flaws that have long been known, according to a report by Palo Alto Networks, a Santa Clara, Calif.-based cybersecurity company. Read More
Integra LifeScience’s TEI Biosciences drew a six-observation Form 483 from the FDA based on an inspection last October and November of the company’s facility in Boston, Mass. Read More
The FDA has issued a warning letter to Wickimed Medical Equipment Manufacturing for violations of good manufacturing practices (GMP) in making its sterile single-use disposable electrodes. Read More