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approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.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

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

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

Doctors see some promise, confusion for patient monitoring devices: study

Two-thirds of physicians "strongly intend" to monitor patients remotely in the future, but less than half predict patients will track every aspect of their health, according to an industry survey.

By David Lim • April 12, 2019

Pharmas see potential in digital therapeutics, but payers still on the fence: Rock Health

Big pharmas like Novartis and Sanofi are among those looking to incorporate software-based therapies into their drug treatment courses, as payers and other stakeholders make sense of which tools qualify.

By Maria Rachal • April 9, 2019

LabCorp partners with Qiagen to speed launch of companion diagnostics

The collaboration leverages ​Qiagen's lab program for newly approved cancer drugs and targeted IVDs.

By Meg Bryant • April 5, 2019

Hackers manipulate lung cancer scans, fool radiologists and AI software in study

Using an artificial intelligence technique called deep learning, hackers can dupe radiologists and AI software 98% of the time in the case of lung cancer, according to a Ben-Gurion University of the Negev study.

By Rebecca Pifer • April 4, 2019

Amazon's Alexa now has HIPAA-compliant features

Six companies taking part in the online giant's invitation-only developer program launched their features Thursday, including Atrium Health, Cigna, Express Scripts and Livongo.

By Shannon Muchmore • April 4, 2019

FDA unveils framework for AI-based medical devices

The agency argued a total product lifecycle approach, including performance monitoring, is needed to regulate artificial intelligence and machine learning software as a medical device.

By David Lim • April 3, 2019

Industry groups seek safe harbor in comments to senator's cybersecurity query

A think tank's analysis of several organizations' recommendations highlights the need for a national strategy and greater collaboration among various stakeholders.

By Meg Bryant • April 3, 2019

Q1'19 digital health investments slow, but IPOs brewing

The latest data from Rock Health shows M&A was also down, with 21 acquisitions compared to quarterly averages of 31 deals in recent years.

By Maria Rachal • April 2, 2019

Bigfoot CEO talks data-driven diabetes care and becoming a service company

In an interview with MedTech Dive, Bigfoot Biomedical CEO Jeffrey Brewer laid out the startup's hopes to crack into the competitive diabetes space.

By Maria Rachal • April 1, 2019

How AI and machine learning are changing prosthetics

"Our bodies natively have control loops at various levels, and that's really where AI comes into play" in creating next-generation prostheses, said Robert Armiger of Johns Hopkins' Advanced Physics Lab.

By Meg Bryant • March 29, 2019

Cardiologists push digital health tools as answer to healthcare funding pressures

A European Society of Cardiology working group wants health systems to reimburse digital health tools for more efficient chronic disease care.

By Nick Paul Taylor • March 29, 2019