Digital Health: Page 2

After stumble, diabetes drives Livongo to top Q3 estimates

A triple-digit jump in diabetes members helped the digital health firm beat and raise expectations.
By Nick Paul Taylor • Nov. 07, 2019
Deep Dive
Retail makes its case, telehealth and voice tech dominate: 6 takeaways from HLTH19

Consumerism has its limits, interoperability rules face execution challenges and more from Las Vegas.
By Rebecca Pifer • Nov. 06, 2019
1st round picks in AI challenge include Mayo, Merck, IBM

CMS said more than 300 organizations applied for the challenge to develop AI tools that can predict unplanned hospital admissions and adverse events as well as methods to help clinicians use data to improve quality.
By Shannon Muchmore • Nov. 04, 2019
Google to acquire Fitbit in $2.1B deal, challenging Apple

The deal deepens the big tech's position in healthcare, giving it a line of wearables that could assess conditions like atrial fibrillation and sleep apnea.
By Maria Rachal • Nov. 01, 2019
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. 08, 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. 08, 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. 07, 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. 03, 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. 02, 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. 01, 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. 01, 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