Digital Health: Page 9
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Retrieved from Istock.
FDA seeks feedback on technologies that can enable healthcare at home
The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.
By Nick Paul Taylor • June 29, 2023 -
Permission granted by Medtronic
Medtronic links 780G insulin pump to benefits in kids as it works to grow sales
A clinical trial found adolescent users of the pump can achieve improved blood glucose control without precisely counting carbohydrates.
By Nick Paul Taylor • June 26, 2023 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Dexcom
Dexcom targets 25M Americans with new CGM aimed at non-insulin-using diabetics
The device will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.
By Nick Paul Taylor • June 26, 2023 -
Courtesy of Bigfoot Medical
Bigfoot links smart insulin pen cap to improved glycemic control in real-world study
Using the system can bring “rapid and durable improvement” in glycemic control for older adults with Type 2 diabetes who use multiple daily injections, researchers found.
By Nick Paul Taylor • June 22, 2023 -
Retrieved from Owlet on June 22, 2023
Owlet receives FDA clearance for prescription pulse oximetry baby sock
Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.
By Nick Paul Taylor • June 22, 2023 -
Courtesy of Masimo
Analysts highlight Masimo’s advantages over Apple, Fitbit ahead of proxy vote
Even as the company faces a battle over its future direction, Stifel analysts said Masimo’s star product could “enhance patient outcomes, optimize care delivery and ‘massively’ reduce costs.”
By Nick Paul Taylor • June 20, 2023 -
Getty Images
Wrist-worn wearable could detect sickle cell pain episodes
By providing early warning of acute pain episodes caused by sickle cell disease, the device could help patients intervene earlier.
By Nick Paul Taylor • June 16, 2023 -
Permission granted by Taylor Wessing
OpinionThe importance of trust in AI as a medical device
Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.
By Alison Dennis • June 15, 2023 -
Courtesy of Fitbit
Americans’ use of healthcare wearables expanding rapidly, survey says
U.S. consumers doubled their use of wearables between 2020 and 2021, with smartwatches outpacing other devices.
By Susan Kelly • June 14, 2023 -
Permission granted by Samsung
Samsung adds heart rhythm notifications to Galaxy Watch to close gap on Apple
The news comes weeks after the FDA granted 510(k) clearance to the new feature, which can be used to detect atrial fibrillation, and positions Samsung to take on other wearable heart monitors from firms including Apple.
By Nick Paul Taylor • June 14, 2023 -
Getty Images
Huma hails 510(k) clearance as boost to digital health product development
The clearance permits Huma to host digital health tools from multiple creators that support screening, diagnosis, dosing recommendations and clinical decisions.
By Nick Paul Taylor • June 13, 2023 -
Courtesy of Penn State University/Huanyu “Larry” Cheng
Low-cost, disposable ‘pencil-on-paper’ sensor opens population health opportunities
Designed by the research team that developed the smart diaper, the paper patch could be used to detect cardiopulmonary disease and treat inflammation, or monitor disease outbreaks.
By Nick Paul Taylor • June 7, 2023 -
Retrieved from Masimo on June 01, 2023
Masimo pushes back against activist investor it argues will cause ‘dysfunction and chaos’
Launching a proxy battle for two board seats, Politan Capital says Masimo is underperforming its peers and making misleading public statements.
By Nick Paul Taylor • June 1, 2023 -
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MedTech Europe sets out position on cybersecurity, making case for reliance on MDR
As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.
By Nick Paul Taylor • Updated June 12, 2023 -
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Slump in medtech VC activity continues as inflation keeps investors on the sidelines
Investors struck deals worth $1.8 billion over the first three months of the year, down from $3.0 billion across the start of 2022.
By Nick Paul Taylor • May 25, 2023 -
Courtesy of Acurable
Acurable prepares to challenge ResMed for sleep apnea diagnosis market
The company’s device records the sounds of the patient’s respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea.
By Nick Paul Taylor • May 25, 2023 -
Justin Sullivan via Getty Images
PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias
In a head-to-head comparison with Apple’s pre-installed software for interpreting ECG data, Pulse AI’s algorithm was better at detecting atrial arrhythmias.
By Nick Paul Taylor • May 23, 2023 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
FTC moves to strengthen Health Breach Notification Rule’s applicability to digital health apps
Regulators are increasingly leaning on the HBNR to crack down on the sharing of sensitive medical data, and the FTC is looking to strengthen its case.
By Rebecca Pifer Parduhn • May 18, 2023 -
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Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight
Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.
By Susan Kelly • May 17, 2023 -
Courtesy of Verily
Diabetes app developers must generate more data on clinical effectiveness, study says
The researchers saw a need for more data on the wider clinical effectiveness of apps in the management of Type 1 diabetes and prediabetes.
By Nick Paul Taylor • May 16, 2023 -
Getty Images
Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors
The Med-PaLM 2 has the ability to review X-rays and mammograms, write reports about images and respond to follow-up questions from caregivers.
By Nick Paul Taylor • May 11, 2023 -
Courtesy of Samsung
Samsung gets FDA clearance for irregular heart notification feature, catching up with Apple and Fitbit
The addition lets Samsung compete with Apple and Fitbit, which can also passively monitor for signs of atrial fibrillation.
By Elise Reuter • May 9, 2023 -
Kevin Dietsch via Getty Images
FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech
The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.
By Nick Paul Taylor • May 9, 2023 -
Permission granted by iRhythm Technologies
iRhythm says it received DOJ subpoena regarding company’s ‘products and services’
The company’s shares fell more than 5% after the federal government requested documents.
By Nick Paul Taylor • May 5, 2023 -
Getty Images
Algorithm may help avoid 40% of kidney transplant rejection misdiagnoses: study
The decision-support system “could have important clinical implications for the management and treatment of transplant recipients,” researchers found.
By Nick Paul Taylor • May 5, 2023
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