Digital Health: Page 29
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Warren, Murray, Smith redouble scrutiny of FDA over Pre-Cert safety, authority
FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot, but acknowledged it will need help from Congress to update what it calls a 40-year-old regulatory paradigm for 21st century technologies.
By David Lim • Oct. 31, 2019 -
Livongo inks pacts with Doctor on Demand, MDLive
The digital chronic disease management company will offer telehealth services to its behavioral health members beginning in 2020, with plans to extend the option to users of its diabetes and hypertension platforms shortly thereafter.
By Linda Wilson • Oct. 29, 2019 -
Sleep apnea testing shifts to the home, survey suggests
Use of home-based testing has more than doubled in the past five years as more sleep centers offer the option, which analysts expect will benefit ResMed.
By Susan Kelly • Oct. 21, 2019 -
Novartis takes step back from marketing Pear prescription digital therapeutics
While Sandoz and Pear Therapeutics are still working together, the Swiss pharma unit will no longer co-promote the recently launched substance and opioid abuse treatments.
By Kristin Jensen • Oct. 17, 2019 -
Fitbit, Bristol-Myers, Pfizer partner to speed earlier diagnosis of AFib
The two drugmakers sell Eliquis, an anticoagulant for stroke prevention in individuals with atrial fibrillation, which reached nearly $4 billion in sales over the first six months of 2019.
By David Lim • Oct. 17, 2019 -
Smartphone health coaching gets some people moving, study says
The Stanford-backed research looked at e-coaching programs that successfully prompted users to increase daily steps. Limitations included a high dropout rate and demographics not representative of the general U.S. population.
By Susan Kelly • Oct. 14, 2019 -
Abbott deepens Type 2 diabetes play with Omada partnership
While CGMs have been most widely adopted among the Type 1 population, Abbott has worked to show the technology's benefit in the under-penetrated Type 2 market, which accounts for 95% of all Americans living with diabetes.
By Maria Rachal • Oct. 14, 2019 -
Amazon Textract now HIPAA-eligible as tech giant expands AI portfolio
Of Amazon's $3.1 billion in operating income last quarter, more than half came from its cloud services business.
By Rebecca Pifer • Oct. 11, 2019 -
Q&A
Medtech investor duo seeks to 'fill the gap' in device sector private funding
As big medtechs turn toward smaller players to fuel their pipelines, Justin Klein and Kirk Nielsen, managing partners of newly formed Vensana Capital, are looking to build out a $225 million portfolio in "a really undercapitalized sector."
By Maria Rachal • Oct. 8, 2019 -
Livongo scores biggest diabetes contract yet
Investors reacted to the news of the BCBS federal employee program agreement by bumping up Livongo's shares more than 18%.
By Nick Paul Taylor • Oct. 8, 2019 -
AI clinical support opens physicians to potential liabilities: JAMA
Legal considerations for doctors using clinical decision support software come amid challenges for regulators attempting to define a framework to oversee the emerging technologies.
By David Lim • Oct. 7, 2019 -
IMDRF cybersecurity guidance favors total product life cycle approach
The International Medical Device Regulators Forum's draft mirrors U.S. regulators' support for a total product life cycle strategy, but does not include a tiered approach to categorizing risk laid out by FDA last year.
By Nick Paul Taylor • Oct. 3, 2019 -
Venture capital investing in digital health cools in Q3: report
A quarterly update from Rock Health said funding for digital health remains near all-time highs but is slowing. A new analysis from Ropes & Gray found startups are increasingly partnering with established life sciences companies.
By Susan Kelly • Oct. 2, 2019 -
Alphabet hires ex-FDA commissioner to lead health strategy, policy
The company's acquisition of Robert Califf comes roughly a year after its subsidiary Google hired ex-Geisinger CEO David Feinberg to lead health strategy.
By Rebecca Pifer • Oct. 1, 2019 -
Q&A
Disruption or integration? Fitbit's health leader on the role of wearables in healthcare
Healthcare Dive spoke with Amy McDonough, general manager and SVP of Fitbit Health Solutions, about the wearables giant's competitors, its Premium offering, and how it's always been a healthcare company at the core.
By Rebecca Pifer • Oct. 1, 2019 -
FDA revises clinical decision support software draft after industry blowback
The decision to revise the draft guidance comes after feedback on the 2017 version asked the agency to reconsider its approach, Bakul Patel, FDA's director for digital health, told MedTech Dive.
By David Lim • Sept. 26, 2019 -
To pitch Pre-Cert to Congress, FDA builds a case first
Enforcement mechanisms and the decision of how the experimental pathway will fit into the current 510(k), De Novo and PMA routes are among the details lawmakers will need to eventually address, an agency official said.
By Kim Dixon • Sept. 25, 2019 -
Medtechs keep shareholders happy, potentially at pipeline's expense: EY
The industry recorded its highest revenues ever within the last year, an analysis by the consultancy shows. Even as R&D spending grew 11%, those investments fell short of the proportion of cash returned to investors.
By Maria Rachal • Sept. 23, 2019 -
FDA creates agencywide tech modernization roadmap
The agency plans to spend the next one to two years upgrading its infrastructure to meet emerging data handling needs.
By Nick Paul Taylor • Sept. 19, 2019 -
Varian buys software developer for AI cancer work
The radiation oncology company is making an undisclosed investment in privately held Oncora Medical to collaborate on development of machine learning-based software.
By Susan Kelly • Sept. 16, 2019 -
FDA clears GE's AI-powered x-ray algorithms for triaging collapsed lungs
GE Healthcare said the technology will help hospitals identify high-priority cases and fast track treatment.
By Nick Paul Taylor • Sept. 13, 2019 -
Apple to start trio of research studies on hearing, heart and women's health
The studies, which will be organized through a new Apple Research app this fall, are being conducted in partnership with various universities, hospitals, associations and the U.S. government.
By David Lim • Sept. 11, 2019 -
FDA looks to define 'triggers' for medical device cybersecurity warnings
When do the benefits of notifying patients of potential risks outweigh possible harms? The agency's Patient Engagement Advisory Committee is weighing in Tuesday.
By Maria Rachal • Sept. 10, 2019 -
With partner iRhythm, Verily ramps up AFib efforts
iRhythm committed almost $18 million to Verily to boost development of technology that helps deliver earlier warnings to individuals with asymptomatic or silent atrial fibrillation.
By Maria Rachal • Sept. 5, 2019 -
Fitbit to wade into care management in pilot this year
The fitness tracker giant also announced it is launching a premium service and plans to develop wellness reports allowing users to share their data with their physician.
By Rebecca Pifer • Aug. 28, 2019
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