Nascent digital therapeutics group defines best practices, ethics code

The two-year-old group is looking to distinguish higher-risk products that claim to prevent, manage or treat a disease from more general digital health lifestyle and wellness apps.

By Susan Kelly • Nov. 13, 2019

Paige gets CE mark for prostate cancer detection technology

The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.

By Nick Paul Taylor • Nov. 13, 2019

Explore the Trendline➔

Medical 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

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. 7, 2019

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. 6, 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. 4, 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. 1, 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

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

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