Insulet gains 'ACE' label for interoperable insulin pump, following Tandem

Diabetes tech company Insulet said Monday FDA granted its commercialized Omnipod Dash system clearance as an alternate controller enabled infusion pump.

By Nick Paul Taylor • Updated Sept. 23, 2019

HIMSS19: CMS plans to host AI challenge, innovation chief says

The goal of the initiative is to spur private interest in the tech, improve the government's grasp on healthcare data, eliminate unnecessary care and cut costs, Adam Boehler said.

By Rebecca Pifer • Feb. 14, 2019

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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

HIMSS19: Digital health 'at peak investment cycle,' expert says

Last year's record level of investment into United States digital health companies came despite a lull in initial public offerings.

By David Lim • Feb. 14, 2019

Software products face high-risk upclassing in Australia

The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.

By Nick Paul Taylor • Feb. 14, 2019

HIMSS19: Verma touts Blue Button 2.0 apps, though uptake still low

Only a few thousand Medicare beneficiaries have elected to share their claims data with production developers, the CMS administrator said.

By David Lim • Feb. 13, 2019

Microsoft debuts healthcare messaging features, new bot service

Microsoft Care Team users can now view integrated EHR data on their mobile device. The company will showcase these and other tools at HIMSS 2019 in Florida next week.

By Meg Bryant • Feb. 8, 2019

Bigfoot adds Owen Mumford needles to diabetes subscription service

The agreement sets Bigfoot up to provide users of its automated insulin delivery devices with pen needles.

By Nick Paul Taylor • Feb. 8, 2019

FDA draft lays out submission paths for combo products

Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.

By David Lim • Feb. 6, 2019

Cognoa's autism devices win breakthrough status

The special FDA designation covers the company's digital devices designed to improve the diagnosis and treatment of autism.

By Nick Paul Taylor • Feb. 6, 2019

Current Health's wearable vital sign monitor gets FDA nod

The 510(k) clearance covers an arm-worn device that monitors variables such as oxygen saturation and alerts healthcare professionals to deviations.

By Nick Paul Taylor • Feb. 6, 2019

Oxipit AI-based tool for chest X-ray analysis gets CE mark

The Lithuania-based startup is betting the system can help radiologists increase productivity, detect hard-to-catch pathologies, decrease error rates and serve as a second opinion.

By Susan Kelly • Feb. 4, 2019

Digital health must catch up to years of hype in 2019, HIMSS says

The Healthcare Information and Management Systems Society also forecasts the sector will face rising consumer pressures and see increased use of social determinants of health data.

By Rebecca Pifer • Jan. 31, 2019

CMS launches app showing Medicare beneficiaries what their plans cover

The app's Blue Button 2.0 functionality also lets people connect claims information to tools that "help them understand, use and share their health data," the agency said.

By Les Masterson • Jan. 29, 2019

CVS-Aetna to offer Apple Watch app for members

The Attain app will allow Aetna members to set personalized activity goals, participate in weekly challenges and earn rewards as they reach milestones.

By Samantha Liss • Jan. 29, 2019

Why home health tech is capturing investment in 2019

Startups and established providers alike are looking at the potential for devices and technology to help patients manage and receive their treatments from the comfort of home.

By Meg Bryant • Jan. 28, 2019

HIMSS19: 5 panels you don't want to miss

The healthcare world is buzzing about what to expect at the biggest IT conference of the year. Here are five key panels you should plan to attend.

By David Lim , Rebecca Pifer • Jan. 28, 2019

Fitbit targets newest activity trackers at health, wellness plans

Fitbit Inspire and Inspire HR are available solely through the company's corporate partners and affiliates.

By Meg Bryant • Jan. 24, 2019

Duke report identifies barriers to adoption of AI healthcare systems

The authors think more evidence and effective risk management will be necessary before AI plays a major role in the diagnosis of disease.

By Nick Paul Taylor • Jan. 24, 2019

Verily Study Watch gets FDA nod for EKG

Unlike the FDA-cleared EKG on Apple Watch, the Google-backed company's Study Watch is a prescription-only device.

By Susan Kelly • Jan. 22, 2019

J&J to study Apple Watch with heart health app

That medtech giant said it would investigate how the product can be used by seniors to flag atrial fibrillation and prevent stroke in conjunction with a J&J heart health app.

By Maria Rachal • Jan. 18, 2019

Health chatbots show potential, but challenges remain

Key barriers to widespread adoption include lack of trust, handling of complex conditions and usability.

By Meg Bryant • Jan. 18, 2019

More seniors may soon be sporting Apple Watches with MA partnerships

Tapping into the Medicare market could be lucrative for Apple and a good business strategy for insurers, given the aging U.S. population and rising healthcare costs.

By Meg Bryant • Jan. 17, 2019

NIH, Fitbit launch real-world data collection effort

The project enables Fitbit users to sync their accounts for access by NIH researchers. It is the first digital health tech initiative in a broader study aggregating lifestyle and biometric data from over 1 million Americans.

By Maria Rachal • Jan. 17, 2019

Neural network matches cardiologists in EKG analysis study

Researchers think the algorithm could improve the triaging of patients.

By Nick Paul Taylor • Jan. 16, 2019

Walgreens to use Microsoft's cloud, AI platform

The companies also plan to pilot up to 12 store-in-store "digital health corners" to market select healthcare-related hardware and devices.

By Meg Bryant • Jan. 15, 2019