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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
San Francisco, Calif-based prescription digital therapeutics company Blue Note Therapeutics has teamed up with clinical trial administrator Curebase for a “virtual” clinical trial to reach patients with cancer-related distress. Read More