Big Data pushing democratization of healthcare, but barriers remain

Obstacles include accessibility, data quality and physician burnout, according to Stanford Medicine's 2018 Health Trends Report.

By Meg Bryant • Dec. 14, 2018

Apple EKG, artificial iris among FDA 2018 device decisions

De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.

By Meg Bryant • Dec. 12, 2018

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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

Australia plans reclassification of medical software to better reflect risk

The country's regulator thinks the current system underestimates the threat posed by software as a medical device.

By Nick Paul Taylor • Dec. 12, 2018

Lawmakers impatient for ONC interoperability rule

"It is hard to explain to people that Congress provided the tools necessary for doctors and patients to better coordinate their care through the sharing of patient data, but nothing has changed," Rep. Michael Burgess, R-Texas, said at a House health subcommittee hearing.

By Rebecca Pifer • Dec. 11, 2018

Pear's digital treatment for opioid abuse gets FDA nod

The app is a medication-assisted treatment that provides cognitive behavioral therapy to increase care retention rates for adults with opioid use disorder.

By Maria Rachal • Dec. 11, 2018

No single telehealth vendor meeting all customer needs, KLAS says

Recent consolidations within the sector, however, could aid the effort to achieve all-purpose telehealth vendors, according to the report.

By Meg Bryant • Dec. 10, 2018

Pear teases top-line data for opioid use digital therapeutic

The app is designed to increase abstinence when used in combination with buprenorphine therapy.

By Nick Paul Taylor • Dec. 6, 2018

Telehealth uptake surprisingly low among physicians, AMA finds

Large and specialty practices are more likely to use telehealth, suggesting that implementation costs are a barrier, according to a new study in Health Affairs.

By Meg Bryant • Dec. 4, 2018

Medtech R&D adapting under new pressures, industry study shows

The shift to value-based payment models and already tight profit margins are ratcheting up pressure, but the device makers are adjusting their R&D investment strategies in response.

By Susan Kelly • Dec. 4, 2018

8 medtech companies get leg up from FDA for opioid devices

Winners of the agency's Innovation Challenge to combat opioid abuse now have access to closer collaboration with FDA as they look to jointly fast track their products to market. 

By Maria Rachal • Dec. 4, 2018

HHS outlines broad plan to reduce EHR burden

The 74-page draft strategy, required by the 21st Century Cures Act, focuses on reducing time and effort tied to regulatory reporting requirements and increasing functionality and user-friendliness of EHRs.

By Meg Bryant • Nov. 29, 2018

Telemedicine use among commercially insured skyrocketed since 2005

Driven by payer coverage for direct-to-consumer telemedicine, annual visits increased by 52% annually from 2005 to 2014 and a whopping 261% from 2015 to 2017, according to a JAMA study.

By Rebecca Pifer • Nov. 29, 2018

BD, Microsoft create software to identify drug diversion

The algorithms analyze dispensing data to spot suspicious activity by clinicians.

By Nick Paul Taylor • Nov. 29, 2018

Cybersecurity, telehealth, tech disruptors top health system concerns for 2019

Nearly 90% of health systems expect to increase spending on cybersecurity in the coming year, many by more than 5%, according to the Center for Connected Medicine.

By Meg Bryant • Nov. 26, 2018

Medtronic buys nutrition data startup for diabetes care

Nutrino Health’s services include artificial intelligence tools for personalized analysis of how nutritional intake will affect a person's health.

By Susan Kelly • Nov. 26, 2018

Sandoz and Pear begin selling digital substance use treatment

The FDA called it the first mobile medical app to treat substance use disorders. Pear raised $50 million to fund the commercialization before deciding to pass responsibility for the introduction onto Sandoz.

By Nick Paul Taylor • Nov. 21, 2018

FDA plan would ease regulations for prescription drug apps

The agency is seeking public comment on a proposed regulatory framework that would treat most prescription drug apps, including dose calculators, symptom trackers and medication reminders, as promotional labeling.

By Susan Kelly • Nov. 20, 2018

Telehealth laws inhibit widespread use in Medicare population, CMS says

The agency is taking steps to open up virtual care options in some alternative payment models, but use among fee-for-service beneficiaries is only 0.25%, according to a new report.

By Meg Bryant • Nov. 19, 2018

Abbott seeks clearer security standards as feds increase cyber risk focus

President Trump is expected to sign legislation Friday creating a new cyber agency within the Department of Homeland Security. 

By Maria Rachal • Nov. 16, 2018

With technology foundation solidified, Johnson & Johnson's attention turns to what's next

Though advanced in its technical capabilities, J&J has weighed the merits of build versus buy when it comes technologies like AI.

By Naomi Eide • Nov. 16, 2018

CMS' Verma outlines vision for connected digital health network

The agency also submitted a report to Congress on the state of Medicare telehealth, outlining how beneficiaries are currently using remote care and how CMS is looking to further expand similar services to rural areas.

By Nick Paul Taylor • Nov. 16, 2018

Philips report identifies barriers to telehealth uptake

Reimbursement issues and access to high-speed internet are among the factors throttling adoption.

By Nick Paul Taylor • Nov. 16, 2018

House chairman sees 'every indication' that VA's EHR difficulties will continue

"Frankly," Indiana Rep. Jim Banks said, "the more I learn about the EHR program, the more daunting it has become." 

By Tony Abraham • Nov. 15, 2018

ResMed wraps up $750M MatrixCare buyout in SaaS push

The sleep apnea company has spent almost $1.7 billion on software businesses in recent years.

By Nick Paul Taylor • Nov. 15, 2018

Millennial to menopausal, women's health is fertile space for startups

Early-stage investors have increased support for female-specific devices and direct-to-consumer diagnostics in the last five years, as the women’s health market is poised to reach $50 billion globally by 2025.

By Maria Rachal • Nov. 14, 2018