Digital Health: Page 2
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Apple Watch, mesh slings among new NESTcc projects
The real-world evidence hub selected 12 new test cases to evaluate its model in medical device regulatory and clinical decision-making.
By Susan Kelly • June 05, 2019 -
Muscle relaxation app helps calm migraine in small NYU study
Migraine sufferers who used the smartphone app at least twice a week had four fewer headache days per month on average.
By Susan Kelly • June 05, 2019 -
House committee passes 6% increase in FDA funding
The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.
By Nick Paul Taylor • June 05, 2019 -
Device industry praises FDA AI/ML framework, asks for Class III software inclusion
AdvaMed and the Combination Products Coalition applauded the agency's work on a regulatory approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.
By David Lim • June 04, 2019 -
Apple Watch's newest health addition: menstrual cycle tracking
With Apple emphasizing information encryption, the cycle tracking feature could impact established smartphone-based apps like Clue and Flo.
By Maria Rachal • June 04, 2019 -
Anti-Kickback Statute safe harbor revisions set for July
The newly released Spring 2019 Unified Agenda lays out government plans to align domestic and international medical device quality systems, define which types of software are considered devices, and more.
By David Lim • May 23, 2019 -
FDA wants new companies to help test its Pre-Cert Program
One pilot company's CEO told MedTech Dive FDA's search for new companies "is not a surprise to us" and "is a really good thing for the Pre-Cert program."
By David Lim • May 23, 2019 -
LifeScan deal challenges Abbott, Dexcom for CGM market
The former Johnson & Johnson unit has teamed with Sanvita Medical to sell continuous glucose monitor systems in North America and some European countries beginning in 2020.
By Nick Paul Taylor • May 23, 2019 -
Real-world operations: NESTcc director on building a business and the future of device evaluation
The National Evaluation System for health Technology and its real-world evidence projects are finally getting off the ground. Now the center needs to secure industry's buy-in, said Rachael Fleurence, executive director.
By Maria Rachal • May 20, 2019 -
Express Scripts to launch formulary for apps, medical devices
The pharmacy benefit manager says its new formulary will include digital health solutions for a host of chronic and complex conditions, including diabetes, cardiovascular, pulmonary and behavioral health issues.
By Rebecca Pifer • May 17, 2019 -
Physicians call for Digital Health Scorecard to validate products
Following the models of consumer product evaluation organizations, doctors want transparent evaluations of new technologies.
By Nick Paul Taylor • May 16, 2019 -
CMS approves Livongo as Medicare Advantage provider
By tapping into the popular Medicare Advantage market, Livongo gains access to a steadily growing segment of the health insurance industry.
By Susan Kelly • May 01, 2019 -
Mayo Clinic accelerator picks include AI, remote patient monitoring tools
Six startups were selected for the first round of a program aimed at exposing early stage medtech companies to investment and go-to-market opportunities.
By Meg Bryant • April 25, 2019 -
Best Buy, Target jump into at-home device market
The partnership is an example of companies reaching customers through mass retailers, tightening the relationship between healthcare and retail.
By Daphne Howland • April 18, 2019 -
WHO weighs in on digital health tools in new report
The World Health Organization reviewed 10 digital health interventions, backing use of mobile devices for functions like clinical decision support and telemedicine. Still, a top official said the strategies are "not a silver bullet."
By Nick Paul Taylor • April 18, 2019 -
AliveCor's AI software for EKG rhythms gets market OK
FDA posted the 510(k) summary for KardiaAI last week. The software supports analysis of data recorded in compatible formats from ambulatory EKG devices such as event recorders.
By Susan Kelly • April 15, 2019 -
Teladoc partners with Cincinnati Children's on pediatric telehealth platform
The pact comes as Teladoc has been expanding its global footprint and products through service rollouts and acquisitions outside the U.S.
By Meg Bryant • April 12, 2019 -
Doctors see some promise, confusion for patient monitoring devices: study
Two-thirds of physicians "strongly intend" to monitor patients remotely in the future, but less than half predict patients will track every aspect of their health, according to an industry survey.
By David Lim • April 12, 2019 -
Pharmas see potential in digital therapeutics, but payers still on the fence: Rock Health
Big pharmas like Novartis and Sanofi are among those looking to incorporate software-based therapies into their drug treatment courses, as payers and other stakeholders make sense of which tools qualify.
By Maria Rachal • April 09, 2019 -
LabCorp partners with Qiagen to speed launch of companion diagnostics
The collaboration leverages Qiagen's lab program for newly approved cancer drugs and targeted IVDs.
By Meg Bryant • April 05, 2019 -
Hackers manipulate lung cancer scans, fool radiologists and AI software in study
Using an artificial intelligence technique called deep learning, hackers can dupe radiologists and AI software 98% of the time in the case of lung cancer, according to a Ben-Gurion University of the Negev study.
By Rebecca Pifer • April 04, 2019 -
Amazon's Alexa now has HIPAA-compliant features
Six companies taking part in the online giant's invitation-only developer program launched their features Thursday, including Atrium Health, Cigna, Express Scripts and Livongo.
By Shannon Muchmore • April 04, 2019 -
FDA unveils framework for AI-based medical devices
The agency argued a total product lifecycle approach, including performance monitoring, is needed to regulate artificial intelligence and machine learning software as a medical device.
By David Lim • April 03, 2019 -
Industry groups seek safe harbor in comments to senator's cybersecurity query
A think tank's analysis of several organizations' recommendations highlights the need for a national strategy and greater collaboration among various stakeholders.
By Meg Bryant • April 03, 2019 -
Q1'19 digital health investments slow, but IPOs brewing
The latest data from Rock Health shows M&A was also down, with 21 acquisitions compared to quarterly averages of 31 deals in recent years.
By Maria Rachal • April 02, 2019
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