Digital Health: Page 6
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Andrii Yalanskyi via Getty Images
Report names connected medical devices with the biggest cybersecurity risks
The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.
By Nick Paul Taylor • April 21, 2023 -
Permission granted by Medtronic
What medtech startups need to know about remote monitoring
Four medtech executives talked about the future of hospital at home, and the difference between consumer devices and medical devices, in an event hosted by the Colorado Bioscience Association.
By Elise Reuter • April 17, 2023 -
Explore the Trendline➔
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 -
Thomas Andreas via Getty Images
iCAD, in midst of restructuring, names three new top executives
The mammography AI company last month said it would lay off 28% of its staff to save money.
By Susan Kelly • April 17, 2023 -
Permission granted by Medtronic
Q&AFriday Q&A: Medtronic’s Ajizian talks connected care ahead of unit spinoff
From supporting AI-driven medical interventions to freeing up providers from administrative tasks, remote patient monitoring is raising the bar for care, says Medtronic’s CMO for patient monitoring.
By Susan Kelly • April 15, 2023 -
Courtesy of Walgreens
OTC hearing aid matches performance of audiologist-fitted device in small trial
People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option.
By Nick Paul Taylor • April 13, 2023 -
Permission granted by Pear Therapeutics
Pear Therapeutics files for Chapter 11 bankruptcy
The maker of subscription apps for insomnia and substance abuse began exploring strategic alternatives earlier this month, and is still seeking a sale.
By Elise Reuter • April 7, 2023 -
Courtesy of HeartFlow
Bain leads $215M investment in AI startup that analyzes coronary artery disease
HeartFlow’s software models a patient’s coronary arteries from imaging, which cardiologists can use to determine the best course of treatment.
By Elise Reuter • April 6, 2023 -
Courtesy of Masimo
Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose
The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.
By Nick Paul Taylor • April 4, 2023 -
Permission granted by Tidepool
Deep DiveGrassroots innovation: How a patient-driven device for diabetes won FDA clearance
Tidepool Loop, an automated insulin dosing app based on one developed by the DIY diabetes community, received FDA clearance in January.
By Elise Reuter • April 3, 2023 -
the rads via Getty Images
FDA drafts guidance to ease path to updates for AI-enabled devices
The guidance describes a framework for changes to medical devices that use machine learning.
By Elise Reuter • March 30, 2023 -
Ewa Krawczyk, National Cancer Institute
Breast cancer AI company iCAD lays off workers, names new CEO
The company, which reported a net loss on Tuesday, is also exploring strategic alternatives for its Xoft therapy business.
By Susan Kelly • March 29, 2023 -
Megan Quinn/MedTech Dive
Bill would require Medicare to cover breakthrough devices for four years
The bipartisan legislation, if enacted, would speed the coverage determination process for FDA-approved devices.
By Susan Kelly • March 27, 2023 -
Courtesy of Antennaware
AntennaWare secures patent for wireless tech designed to unlock implant applications
AntennaWare sees the technology facilitating deep-tissue implants that unlock new ways to monitor and treat disease.
By Nick Paul Taylor • March 27, 2023 -
Permission granted by Movano
Q&AFriday Q&A: Movano takes on the women’s wearables market with a smart ring
Movano Health aims to stand out from the wearables crowd with a women’s health focus and strategy that is centered on obtaining FDA clearances.
By Susan Kelly • March 24, 2023 -
Courtesy of AppliedVR
VR-based pain treatment can be covered as DME, regulators say
The CMS coded AppliedVR’s pain treatment as durable medical equipment, opening a path to insurance reimbursement for similar virtual reality devices.
By Elise Reuter • March 23, 2023 -
SeventyFour via Getty Images
SonderMind acquires technology from Mindstrong ahead of digital health startup’s shutdown
Mindstrong’s collapse comes in a turbulent period for the digital health sector.
By Nick Paul Taylor • March 23, 2023 -
Permission granted by Medtronic
Medtronic, Nvidia to combine forces on AI devices, allowing users to create new software
The companies are working together to allow physicians and developers to build AI applications for Medtronic devices, beginning with the GI Genius endoscopy platform.
By Elise Reuter • March 21, 2023 -
Justin Sullivan via Getty Images
‘Business as usual?’ Investors weigh in on future of medtech startup financing after SVB collapse
Some VC firms say the impact may be limited, while others expect fundraising challenges to linger.
By Elise Reuter • March 20, 2023 -
Permission granted by Pear Therapeutics
Pear, tight on cash, considers strategic alternatives
The digital therapeutics firm is considering a sale, merger, divestiture, licensing, or seeking additional financing.
By Elise Reuter • March 17, 2023 -
Permission granted by Hyfe
Q&AFriday Q&A: A startup founder tackles the riddle of why we cough
Joe Brew, the founder of three-year-old Hyfe, sees the potential for cough-tracking technology to be as ubiquitous as blood-pressure cuffs.
By Susan Kelly • March 17, 2023 -
Permission granted by iRhythm
iRhythm COO resigns amid restructuring
Douglas Devine will stay on as a consultant through 2024, as the company goes through a restructuring to become “a larger digital healthcare organization.”
By Elise Reuter • March 16, 2023 -
Courtesy of Tandem Diabetes
Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids
If Tandem can prove to regulators that the system can help manage young children’s diabetes, it could compete with Medtronic and Insulet, which have devices that are indicated for use in kids as young as two years.
By Nick Paul Taylor • March 16, 2023 -
Permission granted by Osso VR
From ‘huge shock’ to ‘intense relief’: How one medtech startup weathered the collapse of SVB
Osso VR had all of its funds in the failed Silicon Valley Bank, but the company managed the crisis and met payroll.
By Elise Reuter • March 15, 2023 -
SHansche via Getty Images
Medtech trade group pushes UK to support ambitious Software as a Medical Device program
Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts.
By Nick Paul Taylor • March 15, 2023 -
Courtesy of Philips
Philips poaches new connected care business leader from Pear
Julia Strandberg, formerly Pear’s chief commercial officer, must revive a division still struggling with the recall of 5.5 million respirators.
By Elise Reuter • March 13, 2023
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