Digital Health: Page 5
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Courtesy of U.S. Food and Drug Administration
FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices
The agency shortened its list of devices that can continue to undergo limited modifications without 510(k) filings.
By Nick Paul Taylor • Oct. 19, 2023 -
Spencer Platt via Getty Images
Siemens Healthineers partners to improve tuberculosis screening using AI
The company will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria, providing free licenses and helping to integrate AI-enabled processes into clinicians’ workflows.
By Nick Paul Taylor • Oct. 18, 2023 -
Explore the Trendlineâž”
Sitthiphong via Getty Images
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 -
Elise Reuter/MedTech Dive
FDA to establish digital health advisory committee
The agency is seeking advisers to help it understand the benefits, risks and outcomes associated with digital technologies.
By Elise Reuter • Oct. 12, 2023 -
Adobe Stock
AdvaMed elevates digital health center to division, names board
The new division will focus on four core policy priorities under Chair Taha Kass-Hout, chief technology officer at GE HealthCare.
By Susan Kelly • Oct. 10, 2023 -
Chung Sung-Jun via Getty Images
Samsung, b.well partner to collect health data on Galaxy smartphones
Users will also be able to schedule appointments with select providers — including Walgreens, ThedaCare, Lee Health and Rise Health — through the Samsung Health app.
By Emily Olsen • Oct. 10, 2023 -
Elise Reuter/MedTech Dive
Clinicians ‘love yet fear’ AI, say medtech leaders
Stryker, Siemens Healthineers and Google execs said at the MedTech Conference that digital technology can help with patient care, but healthcare professionals also worry about it taking their jobs.
By Elise Reuter • Oct. 10, 2023 -
Permission granted by GE HealthCare
Q&AGE HealthCare imaging CEO Jan Makela talks Mayo Clinic partnership
GE and Mayo Clinic plan to collaborate on imaging, artificial intelligence and cancer treatment.
By Elise Reuter • Oct. 6, 2023 -
the rads via Getty Images
Generative AI matches accuracy, quality of radiologist reports in study
Artificial intelligence models could provide timely alerts and help with image interpretation in life-threatening situations, Northwestern University researchers said.
By Nick Paul Taylor • Oct. 6, 2023 -
Retrieved from Adobe Stock.
Duke researchers find app improves autism screening in NIH-funded study
Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.
By Nick Paul Taylor • Oct. 4, 2023 -
Permission granted by Esper
Sponsored by EsperHealthtech companies dealing with complex device fleets, new report finds
Four ways HealthTech companies are using modern solutions to manage their mission-critical devices.
Oct. 2, 2023 -
Courtesy of Medtronic
Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom
Medtronic has made the sensor smaller and eliminated the need for fingersticks to calibrate the device, bringing a challenger to market leaders Abbott and Dexcom.
By Nick Paul Taylor • Sept. 25, 2023 -
Shutterstock/sfam_photo
Sponsored by Shyft Global ServicesHow can medical device OEMs support the circular economy?
Discover how medical device OEMs can be part of the circular economy for a more sustainable future.
Sept. 25, 2023 -
Nuthawut Somsuk via Getty Images
Is bigger better? McKinsey predicts the return of large medtech mergers
The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.
By Nick Paul Taylor • Sept. 22, 2023 -
Stefan Zaklin via Getty Images
CMS leader defends breakthrough device reimbursement proposal at House hearing
Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.
By Nick Paul Taylor • Sept. 20, 2023 -
peakSTOCK via Getty Images
Gates Foundation grants GE HealthCare $44M for AI ultrasound tech
The money will go to subsidiary Caption Health to make AI tools to help with maternal care and pediatric lung health.
By Elise Reuter • Sept. 19, 2023 -
Lakshmiprasad S via Getty Images
Beacon Biosignals receives FDA clearance for sleep tracking headband
The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.
By Nick Paul Taylor • Sept. 18, 2023 -
Courtesy of GE HealthCare
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI
The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.
By Nick Paul Taylor • Sept. 15, 2023 -
Courtesy of Akili Interactive
Akili cuts 40% of workforce, plans shift to non-prescription model
The digital therapeutics company expects to extend its cash runway into 2025 with the changes.
By Elise Reuter • Sept. 13, 2023 -
Thomas Andreas via Getty Images
Study suggests AI could provide second reading of mammograms
In a separate commentary, researchers described the study as launching “the arrival of prospective trials of AI in the breast screening setting.”
By Elise Reuter • Sept. 12, 2023 -
Permission granted by Intuitive Surgical
Q&AIntuitive’s Tony Jarc on how AI is improving robotic surgery
The company aims to help surgeons achieve better results for patients and hospitals.
By Susan Kelly • Sept. 8, 2023 -
Courtesy of Paige
Microsoft, Paige team to use supercomputers to train cancer pathology AI models
Microsoft will support development of a new model that is “orders-of-magnitude larger” than any in use today.
By Nick Paul Taylor • Sept. 8, 2023 -
Courtesy of Medtronic
Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google
The plaintiff said disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.”
By Nick Paul Taylor • Sept. 5, 2023 -
Courtesy of Beta Bionics
Beta Bionics raises $100M to challenge Medtronic, Tandem for automated insulin dosing market
The company’s iLet Bionic Pancreas automates insulin dosing without requiring mealtime carb counting.
By Nick Paul Taylor • Sept. 1, 2023 -
Courtesy of Withings
Withings wins FDA clearance for scale with AFib detection
The device records the electrical signal from the heart, assesses the number of calories the body burns at rest and tracks other health variables.
By Nick Paul Taylor • Aug. 30, 2023 -
magicmine via Getty Images
GE HealthCare rolls out software to speed assessment of AFib patients
The program aims to cut the time physicians spend searching multiple systems to understand the cardiac history of AFib patients.
By Nick Paul Taylor • Aug. 29, 2023
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