Digital Health: Page 12
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Sponsored by Medrio4 proven participant education techniques to improve electronic collection of informed consent
Patient education is vital to informed consent. Improve your approach with these best practices.
By Nicole Latimer, Chief Executive Officer • Oct. 10, 2022 -
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NovaSight’s digital treatment for lazy eye gets FDA nod, providing alternative to patching
A randomized controlled trial found the digital device to be as effective as wearing an eye patch, the current gold standard for treatment, opening the way for more children to complete necessary therapy for amblyopia.
By Nick Paul Taylor • Oct. 10, 2022 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Courtesy of Owlet
Owlet seeks clearance of blood-oxygen-measuring baby sock after FDA warning letter
Owlet now is a step closer to selling a prescription medical device designed to alert parents when their baby’s heart rate or oxygen saturation levels move outside of prescribed ranges.
By Nick Paul Taylor • Oct. 10, 2022 -
Courtesy of Paige
Q&AFriday Q&A: Paige CEO Andy Moye on how digital pathology is changing the diagnostic game
Commercial laboratories and academic medical centers are starting to adopt digital tools to help pathologists detect cancer, opening a large market for AI-powered diagnostic tools.
By Elise Reuter • Updated Oct. 8, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Dexcom, Abbott have ‘massive opportunity’ with new CGM coverage proposal: analysts
Analysts at J.P. Morgan said the proposal reads “very favorably” for the two leading makers of continuous glucose monitors and unlocks “a major near-term driver for growth.”
By Nick Paul Taylor • Oct. 7, 2022 -
Courtesy of Dexcom
Dexcom starts global rollout of G7 CGM system, launching device in U.K. and Germany
Software updates have delayed the introduction of the product in the U.S. at a time when the company seeks to take market share from rival Abbott.
By Nick Paul Taylor • Oct. 6, 2022 -
Stock via Getty Images
Genentech, Winterlight track changes in Alzheimer’s using automated speech-based system
The researchers called the system a “promising prototype,” while cautioning that further validation is needed.
By Nick Paul Taylor • Oct. 5, 2022 -
vorDa via Getty Images
Digital health funding collapsed in Q3, falling to lowest level since 2019: analysts
Analysts at Rock Health said “the market isn’t the same as it was” after seeing a sharp drop in late-stage deals.
By Nick Paul Taylor • Oct. 5, 2022 -
Stock via Getty Images
Medical machine-learning studies lack high-quality clinical trials, review shows
The findings “highlight areas of concern regarding the quality of medical machine learning RCTs and suggest opportunities to improve reporting.”
By Nick Paul Taylor • Oct. 4, 2022 -
Courtesy of Illumina
European AI Act could have ‘significant impact’ on manufacturers, medtech group warns
“Overregulation and misalignment” could create uncertainty and stop products from coming to market, MedTech Europe says.
By Nick Paul Taylor • Oct. 3, 2022 -
BillionPhotos.com
Digital pathology gains momentum among US providers, vendors: report
Already popular in Europe, digital pathology technologies are primed for growth in the U.S., according to a report from KLAS research.
By Hailey Mensik • Sept. 30, 2022 -
Permission granted by iRhythm Technologies
Q&AFriday Q&A: iRhythm CEO Quentin Blackford on how the heart monitor maker plans to reach $1B in sales
Continuing the company’s success in the U.S. and expanding internationally are the two biggest factors to achieving its $1 billion forecast, says Blackford.
By Ricky Zipp • Sept. 30, 2022 -
Pixelseffect via Getty Images
Bionic pancreas led to lower blood sugar levels than standard of care: study
The results point to the potential for a simplified approach for automated insulin delivery that could be particularly useful for patients without regular access to an endocrinologist.
By Elise Reuter • Sept. 29, 2022 -
Sarah Silbiger via Getty Images
FDA finalizes guidance on how clinical decision support software is regulated
The FDA has overhauled the 2019 draft, deleting some sections and completely rewriting other parts of the document.
By Nick Paul Taylor • Sept. 28, 2022 -
Sarah Silbiger via Getty Images
FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program
The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.
By Nick Paul Taylor • Sept. 27, 2022 -
Kirill Smyslov via Getty Images
Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study
If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions.
By Nick Paul Taylor • Sept. 23, 2022 -
Permission granted by Scripps Research
Q&AFriday Q&A: Scripps’ Jay Pandit talks about wearables, decentralized trials and what’s next for digital health
As wearables confirm their ability to collect data, the big question is what to do with it all. And the next technical challenge: improving wrist-based blood pressure monitors.
By Elise Reuter • Sept. 22, 2022 -
Courtesy of https://www.dbl-diabetes.com/wp-content/uploads/2022/03/1114x708-dblg1-system-overview-EN.jpg.webp
Diabeloop’s insulin algorithm shows 17-point rise in time-in-range from year-long patient study
About half of the people using its device achieve the recommended outcomes, versus 27% of those using standard treatment.
By Nick Paul Taylor • Sept. 22, 2022 -
Courtesy of Insulet Corp.
Insulet’s Omnipod 5 gains CE Mark for European release
After months of regulatory delays, Insulet’s newest insulin pump can now be marketed in the U.S. and European Union.
By Nick Paul Taylor • Sept. 21, 2022 -
Courtesy of https://news.medtronic.com/MiniMed-R-670G-Hybrid-Closed-Loop-System#assets_34137_21-122
Medtronic issues urgent notice about MiniMed insulin pump system vulnerability
Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.
By Nick Paul Taylor • Sept. 21, 2022 -
Sony partners with hearing aid specialist to enter new over-the-counter market
Sony has identified the U.S. regulatory change as a chance to use its brand and audio technology to add a new growth driver to its portfolio.
By Nick Paul Taylor • Sept. 14, 2022 -
Courtesy of Press release https://verily.com/blog/verily-expands-stephen-gillett-s-role-to-president-and-chief-operating-officer/
Google sibling Verily raises $1B to invest in health data initiatives, replaces CEO
The investment strengthens Verily’s position and continues Big Tech’s push into the healthcare space.
By Nick Paul Taylor • Sept. 12, 2022 -
PeopleImages/Getty via Getty Images
Machine learning algorithm predicts unfavorable labor outcomes for mothers in retrospective study
The researchers plan to validate the model using Mayo Clinic patients before deploying it prospectively in maternity wards.
By Nick Paul Taylor • Sept. 6, 2022 -
Permission granted by iRhythm Technologies
Q&AFriday Q&A: iRhythm CTO Mark Day talks Zio Watch, Verily partnership, Big Tech in healthcare
Day spoke about developing a smartwatch for cardiac monitoring with Alphabet’s Verily, competing with Apple and building clinical evidence for the new product.
By Ricky Zipp • Sept. 2, 2022 -
Courtesy of Medtronic
Medtronic grows patient monitoring offerings with BioIntelliSense partnership
Wearable patient monitors can help with healthcare staffing shortages, an ongoing challenge for hospitals, and create an opportunity for device makers.
By Ricky Zipp • Sept. 1, 2022
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