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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
CardioQuip of College Station, Tex., has received a warning letter from the FDA for making changes to its cardiac heater-cooler without notifying or receiving permission from the FDA. Read More