A bipartisan group of Michigan lawmakers sent the FDA a letter yesterday calling for stronger guidance in testing bone tissue products and screening donors. The statement comes as the CDC works to control a U.S. tuberculosis outbreak that spread via infected bone material used by dentists and orthopedic surgeons. There have been two deaths and at least 36 exposures. It’s the second tuberculosis outbreak linked to the biomaterial device company, Aziyo Biologics.
There’s no commercially available tuberculosis test for bone tissue. Even if that test existed, neither the FDA nor the American Association of Tissue Banks require companies to test their donor materials for TB.
Sens. Gary Peters and Debbie Stabenow, along with Reps. John Moolenaar and Debbie Dingell, told the FDA they had been contacted by a physician at the Michigan Medicine hospital system whose patient died of TB in August after being implanted with the material. The lawmakers urged the FDA to adopt the American Association of Tissue Banks’ recent, more stringent standards for donor screening.
“We urge the FDA to consider these recommendations and promptly
issue guidance or regulations based on sound science to protect patients and increase accountability for human tissue transplant products,” they wrote.
What’s going on at Biofourmis?
Once valued at $1.3 billion, Biofourmis appears to be in a bit of trouble. Yesterday, I reported that the company’s founder and CEO Kuldeep Singh Rajput quietly stepped down from his role without having a successor in place, just a month after his company laid off 120 people. Ben Wanamaker — formerly of Humana, Aetna, and Walmart has joined the Biofourmis board — and will oversee the company’s leadership until a new chief executive is found.
Over the years, Biofourmis has raised close to half a billion dollars and dabbled in several flavors of tech-enabled care delivery for health systems and digital support for biopharma companies. This summer, the company issued a press release bragging about all its progress over the last year, at the very same time that the layoffs were happening. Now the CEO is out — what’s going on?
Maybe don’t ask Alexa for help with CPR
If your dinner companion chokes and is in sudden need of CPR, do not ask Siri or any other voice assistant for help. Your phone is your best friend: Use it to call 911.
That’s the takeaway from a new study in which researchers asked four commercial voice assistants as well as OpenAI‘s ChatGPT a series of different questions about CPR. According to the researchers, the assistants performed poorly, answering with responses about CPR 59% of the time. In several cases, assistants simply said they didn’t know. (Microsoft‘s Cortana twice answered “words fail me” — yikes.) ChatGPT, unsurprisingly, performed much better, but it is unable to speak its responses.
The researchers suggest that voice assistants ought to be programmed to offer CPR instructions using designated CPR commands. Sure! I bet the developers at tech giants are working overtime to get the feature out in time for the holiday shopping season.
The latest breakthrough devices
As we close out summer, it’s time for an update to our Breakthrough Devices Tracker. The FDA’s breakthrough devices program is designed for companies working on novel, potentially life saving therapies. Because these devices are thought to have more promise, the agency can “live with more uncertainty” about their effectiveness, as an FDA cardiovascular official said at a panel last week. So while the breakthrough program is helpful for companies, its value to patients is less clear.Here are some notable devices that have snagged the breakthrough designation since June:
- T2 Biosciences announced breakthrough status for its rapid test of the fungal pathogen candida auris.
- Singapore-based Mirxes announced its designation for a gastric cancer blood test.
- Fasikl announced breakthrough status for two of its products: a nerve-computer interface that allows amputees or paralyzed patients to control a robotic arm or computer, and a neurostimulation device to relieve chronic pain in amputees.
- Anumana earned the designation for an AI algorithm to help detect cardiac amyloidosis, an often undiagnosed cause of heart failure.
Industry news
- Users of Oura smart rings can now share reports about their sleep with their therapists on virtual mental health platform Talkspace. “For both companies, we see this partnership as a way of enhancing our offering to current members and potentially introducing ourselves up to each other’s’ respective audiences,” Katelyn Watson, chief marketing officer at Talkspace, told me over email.
- Hospital giant HCA and Google Cloud announced a partnership aimed at using generative AI “to improve workflows on time-consuming tasks, such as clinical documentation.”
- Drug discounts platform GoodRx announced a new feature that will allow providers to check how much drugs would cost patients by comparing GoodRx discounts, manufacturer coupons, and insurance-covered prices in one place.
What we’re reading
- Disney, The New York Times and CNN are among a dozen major media companies blocking access to ChatGPT as they wage a cold war on A.I., CNN
- New law to implement telehealth medicine inside ambulances, KCBD
- The A.I. surveillance tool DHS uses to detect ‘sentiment and emotion’, 404
- Large language models aren’t people. Let’s stop testing them as if they were, MIT Technology Review
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