FDA 'white hat' hacking tools may combat medical misinformation

Cybersecurity techniques the agency uses to protect medical devices could also help fight the spread of medical misinformation, former FDA Commissioner Robert Califf wrote in a journal.

By Susan Kelly • June 17, 2019

Margin for error 'almost zero' in testing pediatric devices

As barriers dog pediatric device development, one FDA-backed group is trying a different path.

By Maria Rachal • June 14, 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

AMA adopts measures to shape development, uptake of AI systems in healthcare

The policies seek to ensure developers of AI, not physicians, are liable for medical errors involving the technologies.

By Nick Paul Taylor • June 13, 2019

China leads world in digital health adoption, Philips survey finds

Healthcare professionals in China are more likely to recommend patients use digital health technologies than their peers in the West.

By Nick Paul Taylor • June 12, 2019

Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA

Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.

By Nick Paul Taylor • June 11, 2019

Abbott and Tandem in the spotlight at diabetes meeting

Abbott is sharing details of its FreeStyle Libre 2 CGM system, and Tandem is presenting data on its automated insulin delivery system.

By Nick Paul Taylor • June 7, 2019

Consumers favor mobile health when paired with office visits

Three-quarters of patients surveyed by SOTI said mobile products improve convenience, though popularity and use of different types of services varied.

By Tony Abraham • June 6, 2019

Executives expect AI to transform healthcare within 3 years

Almost 90% of industry leaders are trying AI and other emerging technologies, and high percentages also believe health IT can help them identify unmet consumer needs, according to a report from Accenture.

By Nick Paul Taylor • June 6, 2019

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 5, 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 5, 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 5, 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 4, 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 4, 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 1, 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