FDA targets De Novo path to shepherd medical software through Pre-Cert

One industry lawyer questioned if the agency's most recent iteration will limit the program's potential by relying on the De Novo pathway, historically used rarely compared to its 510(k) program.

By David Lim • Jan. 8, 2019

Alphabet's Verily snags $1B in funding round

Leading the pack of investors was private equity firm Silver Lake. The money will go toward strategic partnerships, global business opportunities and potential acquisitions.

By Meg Bryant • Jan. 7, 2019

What's in a connected medical device? Cybersecurity regulators want to know

FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.

By Meg Bryant • Jan. 3, 2019

FDA-backed NESTcc set to publish 2019 RWE strategy

The real-world evidence group is seeking to build on a busy 2018 that saw it team up with Abbott, Johnson & Johnson and other companies.

By Nick Paul Taylor • Jan. 3, 2019

Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018

Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.

By Maria Rachal • Dec. 22, 2018

3M completes acquisition of MModal's tech business for $1B

The manufacturer plans to use MModal's cloud-based, conversational AI technology in areas like population health, where 3M is already active. 

By Meg Bryant • Updated Feb. 4, 2019

FDA-cleared, wearable blood pressure device hits market

A cuff in the wrist watch band inflates to capture systolic and diastolic pressure.

By Maria Rachal • Dec. 21, 2018

Walgreens teams up with Alphabet's Verily on medication adherence pilot

The two companies said they are seeking to improve care for those with chronic conditions such as Type 2 diabetes.

By Samantha Liss • Dec. 20, 2018

Livongo names Cerner's Burke as new CEO

Current CEO Glen Tullman will take the title of executive chairman. Tullman told MedTech Dive in an interview before the move that revenue is set to more than double in 2018 to about $61 million.

By David Lim • Dec. 19, 2018

Researchers advance 3D-printed, wirelessly-controlled ingestible

The multi-purpose device could spend a month or more in the stomach as a diagnostic tool or drug delivery mechanism.

By Nick Paul Taylor • Dec. 19, 2018

Fitbit updates smartwatches with new OS, more apps, developer tools

The wearables company has been upping its game in the health sector this year with its acquisition of Twine Health and the launch of Fitbit Care, which combines coaching and virtual care to help people manage chronic conditions.

By Meg Bryant • Dec. 18, 2018

Medtronic wins FDA OK for InterStim smart programmer

The device giant also got its Navion stent graft system to be included in an aneurysm repair study with Aortica software.

By Susan Kelly • Dec. 18, 2018

Novartis, Pear move digital schizophrenia drug into Phase 2

The trial will assess whether behavior therapy software can improve the symptoms of people with schizophrenia.

By Nick Paul Taylor • Dec. 18, 2018

The profit equation: Using analytics to solve for growth in medtech

Why analytics is key to optimizing operations and commercial spend for medtech companies.

By Bhargav Mantha • Dec. 17, 2018

Nonprofit gets boost to realize automated insulin delivery app

The software is meant to work with multiple insulin pumps and continuous glucose monitoring devices and will be designed for the iOS App Store as an FDA-regulated mobile application, said diabetes technology nonprofit Tidepool.

By Susan Kelly • Dec. 17, 2018

Apple has at least 40 doctors across teams, CNBC reports

The physician hires could help to sell providers on the clinical worth of the tech giant's health-related products.

By Meg Bryant • Dec. 14, 2018

FDA: Benefits beat risks with unregulated medical software

The agency reviewed safety and best practices for technologies like e-prescribing tools and mobile wellness apps, building on prior 21st Century Cures guidances addressing software as a medical device.

By Maria Rachal • Dec. 14, 2018

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

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 Parduhn • 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