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STAT+: Blood pressure tech floods the market after FDA relaxes wearables oversight
In early January, the Food and Drug Administration delivered on the Trump administration’s deregulatory promises by allowing more wellness products to be marketed without the agency’s authorization. Leaders at smart ring maker Oura swiftly planted the pivot foot.
“As soon as this guidance came out, literally the same day, we started having conversations with our product team around what our roadmap looks like, features that we could bring in and actually ship sooner,” Ricky Bloomfield, the company’s chief medical officer, told STAT less than a week after the FDA announcement. He added: “this guidance helps give us more confidence that we can release features sooner and not have to spend months getting additional clarification from the FDA.”
One thing FDA clarified in the updated guidance is that companies can release products that use sensors to “estimate, infer, or output” blood pressure and blood glucose readings without approval, if they are intended for wellness purposes. In a speech at the Consumer Electronics Show the day the guidance was announced, the FDA commissioner at the time, Marty Makary, said his agency would “get out of the way” of products that weren’t making medical or clinical claims. “This reduces the amount of subjectivity by regulators and guesswork by developers,” he said.
Five months later, consumer technology giants have already taken advantage. Oura on Thursday announced a refreshed model of its ring and a battery of new features, including two aimed at providing users with insights on blood pressure. In March, Samsung released a smartwatch feature that offers users readings of their systolic and diastolic blood pressure.
Elsewhere, upstart developers are racing to market with do-it-all devices. A smart ring called the Pin Pulse, which claims to offer readings of blood pressure, blood glucose, sleep insights, and more, raised $260,000 in a Kickstarter campaign that ended in April. The product was conceived by recent University of California, Berkeley graduate students who partially outsourced technical development to a team in China.
Optimistically, the new wave of blood pressure products may help raise awareness about a deadly hypertension epidemic, regulatory and clinical experts told STAT. After all, nearly half of American adults have high blood pressure, and many people have no idea until they have a heart attack. Realistically, experts are concerned that the underlying technology is still novel and unproven, and that a flood of confusing features may mislead users about the state of their health and prevent them from pursuing necessary care.
In early January, the Food and Drug Administration delivered on the Trump administration’s deregulatory promises by allowing more wellness products to be marketed without the agency’s authorization. Leaders at smart ring maker Oura swiftly planted the pivot foot.
“As soon as this guidance came out, literally the same day, we started having conversations with our product team around what our roadmap looks like, features that we could bring in and actually ship sooner,” Ricky Bloomfield, the company’s chief medical officer, told STAT less than a week after the FDA announcement. He added: “this guidance helps give us more confidence that we can release features sooner and not have to spend months getting additional clarification from the FDA.”
One thing FDA clarified in the updated guidance is that companies can release products that use sensors to “estimate, infer, or output” blood pressure and blood glucose readings without approval, if they are intended for wellness purposes. In a speech at the Consumer Electronics Show the day the guidance was announced, the FDA commissioner at the time, Marty Makary, said his agency would “get out of the way” of products that weren’t making medical or clinical claims. “This reduces the amount of subjectivity by regulators and guesswork by developers,” he said.
Five months later, consumer technology giants have already taken advantage. Oura on Thursday announced a refreshed model of its ring and a battery of new features, including two aimed at providing users with insights on blood pressure. In March, Samsung released a smartwatch feature that offers users readings of their systolic and diastolic blood pressure.
Elsewhere, upstart developers are racing to market with do-it-all devices. A smart ring called the Pin Pulse, which claims to offer readings of blood pressure, blood glucose, sleep insights, and more, raised $260,000 in a Kickstarter campaign that ended in April. The product was conceived by recent University of California, Berkeley graduate students who partially outsourced technical development to a team in China.
Optimistically, the new wave of blood pressure products may help raise awareness about a deadly hypertension epidemic, regulatory and clinical experts told STAT. After all, nearly half of American adults have high blood pressure, and many people have no idea until they have a heart attack. Realistically, experts are concerned that the underlying technology is still novel and unproven, and that a flood of confusing features may mislead users about the state of their health and prevent them from pursuing necessary care.
Hosted by Drug Discovery World and supported by Sartorius and BioIVT, this webinar will explore the opportunities and challenges that exist within cancer research drug discovery and development.
You will hear from Dr Sudha Rao, Chief Scientific Officer of Kazia Therapeutics, Karol Budzik, PhD, Business Development Associate at Vyriad Therapeutics and Lars van der Veen, Chief Scientific Officer at iOnctura.
Presentations will cover how cancer treatments have shifted towards reprogramming the biology driving tumour growth, immune escape and treatment resistance, the trajectory that in vivo CAR-T treatments are taking, and how challenging tumours burdened by stroma and immune-mediated resistance can be tackled.
Q&A with the speakers follows the presentations.
The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).
Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.
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New Spectrometry Technique Could Aid Formulation Development
New Spectrometry Technique Could Aid Formulation Development
A new technique combining two forms of spectrometry could help biopharmaceutical companies improve their choice of formulation buffer for antibody manufacturing by revealing how molecular forms and three-dimensional shapes of complex biologics respond to their environment. That’s the view of Christian Bleiholder, PhD, a professor at Florida State University who helped develop the technique.
According to Bleiholder, what happens structurally when a complex biological molecule, such as an antibody or viral spike protein, binds to its target is currently poorly understood.
“This is where [this approach] can help with the bioprocessing and formulation,” he says, as structural changes “can affect the lifespan [of the product] and lead to issues, such as aggregation.”
Because antibodies are complex, existing techniques tend to be powerful at different levels of complexity, he explains. Mass spectrometry is particularly powerful for distinguishing molecular composition, while structural approaches such as X-ray crystallography and cryo-electron microscopy can provide high-resolution structural information.
The challenge is understanding the link between these things within a heterogeneous sample, he says.
To overcome this, Bleiholder and his team worked with Bruker Daltonics to develop Tandem-Trapped Ion Mobility Spectrometry (Tandem-TIMS). This combines tandem ion mobility spectrometry with tandem mass spectrometry to disentangle three overlapping layers of molecular complexity: molecular form, three-dimensional shape, and binding or assembly state, he says.
He explains that, if the proteins have different structures, they can be characterized with tandem ion mobility spectrometry, and then mass spectrometry can be used to look at their molecular forms and binding states.
Going forward, Bleiholder hopes the technique can be used for formulation development but also earlier, during drug discovery of new products, such as multi-specific antibodies, to determine which molecular states are important and how those change when a biologic engages its target. He also plans to look at automating the technique.
Bleiholder spoke about using Tandem-TIMS at the Bioprocessing Summit in Boston earlier this year.
The post New Spectrometry Technique Could Aid Formulation Development appeared first on GEN – Genetic Engineering and Biotechnology News.
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