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FDA greenlights device to combat bladder issues
Overactive bladder can be a debilitating condition — but those affected now have a new treatment option. Last week, the FDA authorized a small ankle implant with an accompanying wearable that provides stimulation, both built by BlueWind Medical. The stimulation, called tibial neuromodulation, blocks abnormal nerve signals around the bladder.
BlueWind tested its device on 151 women and found that around 75% of them responded to the therapy, experiencing 50% fewer bladder leaks. They recorded no adverse events. The company has not tested against a placebo control, CEO Dan Lemaitre said, because it didn’t have the money. But he plans to run one now that the implant is on the market.
“We are going to expand this market,” Lemaitre said. “We’re going to drive new patients into the treatment regimen. These are the folks that are sitting on the sidelines.”
Tibial neuromodulation isn’t new, but it’s typically administered via an acupuncture-like needle in the clinic once a week — making it inconvenient for older patients. Sacral neuromodulation, which involves stimulating nerves near the pelvis, is a more effective option, but is more invasive.
“We see patients who are driving from three, four hours away,” said Alexis Dieter, a urogynecologist at MedStar Health, who’s not involved with BlueWind but is helping test a similar technology developed by Coloplast. “This really expands the options for patients, especially those who don’t have immediate access to a urogynecologist.”
FDA panel evaluates high blood pressure procedure
Starting today, a panel of outside experts will deliberate on whether renal denervation, a one-time surgical procedure that works to reduce blood pressure, is clinically beneficial. The promise — and the potential market — is enormous, but the data on how well the procedure works remains contentious.
The committee will evaluate data from two companies vying for market approval: Recor Medical, a startup owned by Japanese company Otsuka Medical devices, and device giant Medtronic, both of which have made surgical device systems to treat hypertension. Though the data leans positive, it does not clearly prove the benefits of renal denervation over blood pressure medications. Medtronic’s data in particular is expected to prove controversial among the panel’s experts, whose recommendation the FDA is likely to follow.
“The real questions are, how much uncertainty is there in this assessment of benefit?” said Robert Yeh, member of the panel and interventional cardiologist at Beth Israel. “How do we weigh that against both the potential harms of the device, as well as the need to address this really important public health problem in an expeditious fashion?”
Digital health’s shift from consumers to employers
For consumers, the promise of telehealth is all about convenience — get the prescription you need quickly, right to your door. But as digital health companies build out their weight loss businesses, capitalizing on the popularity of drugs like Wegovy and Ozempic, they’re courting a very different audience: payers and employers who have a vested interest in preventing quick scripts.
Payers are reeling as they try to figure out how to sustainably cover GLP-1 receptor agonists, a class of remarkably effective but expensive obesity and type 2 diabetes drugs. So in the last six months, digital health companies including Teladoc, Found, Hello Alpha, and Calibrate have advanced enterprise products that pair virtual visits and prescriptions with lifestyle coaching. Their hope is that more and more payers and employers will offer their programs as a way to support lasting weight loss and metabolic health — or even require them if patients want their drugs reimbursed.
Competition in the space is quickly heating up. Read more from STAT’s Katie Palmer here.
Most Americans encounter health misinformation
Health misinformation continues to be pervasive, according to a new survey from the Kaiser Family Foundation. The poll reveals that at least four in 10 people say they’ve heard 10 specific false claims about Covid-19, reproductive health, and gun violence.
The good news is that few said that any of the false claims were “definitely true,” with only 3% saying they believed Covid-19 vaccines cause infertility. But roughly 50% to 75% of respondents were unsure if the 10 false claims were true or not, labeling them “probably true” or “probably false.” Even if misinformation doesn’t completely steer people wrong, it does sow uncertainty.
“Most people aren’t true believers in the lies or the facts about health issues; they are in a muddled middle,” KFF president and CEO Drew Altman said in a press release. “The public’s uncertainty leaves them vulnerable to misinformation but is also the opportunity to combat it.”
Check out the KFF poll here.
Industry deals and moves
- Brian Hansen, chief commercial officer of diabetes tech company Tandem, will resign in December. He’s worked for the company since 2016.
- Digital health company DUOS, a platform for Medicare beneficiaries, appointed Jenn Kerfoot as its chief strategy and growth officer on Monday. Kerfoot was previously at FarmboxRx.
- Getinge recalled 4,586 heart pumps for shutting down unexpectedly due to electrical failure. The company received 252 complaints, but no reports of injuries or deaths.
- Bimini Health Tech, plastic surgery device company, acquired the assets of breast implant company Ideal Implant, Inc. on Thursday. Ideal Implant ceased operations in May, leaving patients concerned about having defunct devices in their bodies.
What we’re reading
- More screen time linked to delayed development in babies, study finds, The New York Times
- The fight over what’s real (and what’s not) on dissociative identity disorder TikTok, The Verge
- Unique device identifiers for medical devices at 10 years, JAMA