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Around the nation: FDA warns of glucose monitors linked to injuries, deaths


FDA recently issued an "early alert" about malfunctioning glucose monitors manufactured by Abbott Diabetes Care that have been linked to hundreds of injuries and at least seven deaths, in today's bite-sized hospital and health industry news from California, Maryland, and North Dakota.

  • California: Hims & Hers Health has agreed to acquire YourBio Health, a medical device company focused on blood sampling technology. The acquisition will allow Hims to add YourBio's TAP device, which uses small, thin needs to collect capillary blood samples, to its offerings. "The next generation of health innovation will be built on proprietary technologies that make wellness simpler, more comfortable, and more human," said Hims founder and CEO Andrew Dudum. "YourBio's patented TAP and HALO technologies represent major advancements in user experience and design, and we're excited to bring them into the Hims & Hers ecosystem." The deal is expected to close early next year. Over the last year, Hims has acquired several companies, including the Canadian digital health platform Livewell, the European digital health platform Zava, and a U.S.-based peptide manufacturing facility. (Landi, Fierce Healthcare, 12/4; Famakinwa, Modern Healthcare, 12/3)
  • Maryland: FDA recently issued an "early alert" about malfunctioning glucose monitors manufactured by Abbott Diabetes Care. According to the agency, internal testing from Abbott shows that some FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices may show incorrect, low glucose readings — something that could lead to incorrect treatment decisions and negatively impact patients' health over time. Around 3 million devices are affected by the issue. As of November, there have been 736 reports of "severe adverse events" related to the devices, including 57 in the United States. There have also been seven deaths associated with the issue, which have been outside the United States. According to Abbott, customers can visit www.FreeStyleCheck.com to determine if their device has been affected. The company will also replace any faulty sensors with no charge to customers. (Ramsey, The Hill, 12/4; Wise, NPR, 12/6)
  • North Dakota: Abortion is once again illegal in North Dakota after the state Supreme Court reversed a judge's earlier ruling. According to the New York Times, abortion rights in North Dakota have undergone significant back and forth since 2022, when Roe v. Wade was overturned. In 2023, the state legislature repealed a trigger ban on abortion after several court rulings before passing an identical law that included medical exceptions. A judge later overturned the ban in 2024, but the decision was appealed by attorney general Drew Wrigley (R). Last month, the North Dakota Supreme Court overturned the 2024 ruling and reinstated the state's near-total abortion ban. Currently, it is a felony in North Dakota for doctors to perform an abortion unless it is to protect a pregnant person's life or health or in cases of rape or incest in the first six weeks of pregnancy. Although patients are protected from prosecution, doctors who perform abortions could face up to five years in prison and a $10,000 fine. Many medical providers in North Dakota and nearby areas said that the ruling would exacerbate fears about medically necessary abortions for both patients and providers. "It is extremely confusing," said Ana Tobiasz, a doctor of maternal-fetal medicine and a plaintiff in the case. "What I foresee is people going back to being fearful of 'Is this actually going to meet the exception?'" (Rao, New York Times, 11/22)

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