Harvard, INSEAD authors pitch systemic regulatory approach to AI/ML devices

A new paper in Nature's digital medicine journal argues that real-world performance of specific SaMD products using artificial intelligence will vary considerably by hospital and other factors.  

By Nick Paul Taylor • April 8, 2020

Digital health rakes in record $3.1B in Q1, but coronavirus slump may loom

"Though some of the economic blow will be tempered by demand for connected healthcare, we do not anticipate investment activity to keep pace with Q1 levels in the coming months," a new Rock Health report says.

By Rebecca Pifer • April 7, 2020

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

FDA clears Sectra's digital pathology module for primary diagnostics as US market heats up

The clearance will intensify competition in the space initially monopolized by Philips, with big medtechs like Roche aiming to enter. The ability to review images from anywhere may be critical amid the coronavirus pandemic.

By Nick Paul Taylor • April 2, 2020

In Pre-Cert 1st, FDA clears app-based treatment for chronic insomnia

Pear Therapeutics, one of nine initial participants in an FDA pilot that rethinks software regulation, touted the product as the first to be submitted through the 510(k) pathway while also reviewed as part of Pre-Cert.

By Maria Rachal • March 27, 2020

Digital health advice from FDA amid coronavirus leaves more questions than answers

While the agency doesn't consider most apps and software systems for COVID-19 public health surveillance and communication to be regulated medical devices, the scope of regulation remains murky.

By Greg Slabodkin • March 27, 2020

FDA still trying to fine-tune Pre-Cert as pilot enters 2020

The Pre-Cert​ pilot, which includes Apple, J&J and Fitbit, is moving forward with the agency "working through the nine companies, trying to figure out how they actually do business," FDA's Bakul Patel told MedTech Dive.

By Greg Slabodkin • March 25, 2020

CDRH pushes out response due date extensions, teleconference policy by at least a month

Less than two weeks after FDA wrote to industry extending deadlines for premarket application responses and warning of disruptions to in-person meetings, the agency lengthened those coronavirus-era changes.

By Maria Rachal • Updated April 6, 2020

Disease management firms set to capitalize on Trump admin interoperability push

A key detail of a rule finalized last week could make it simpler for Omada Health, Propeller Health and Livongo to interface with large health system clients.

By Rebecca Pifer • March 17, 2020

HIMSS20 canceled over coronavirus concerns

"Cancellation is unavoidable in order to meet HIMSS' obligation to protect the health and safety of the global HIMSS community," conference organizers told vendors Thursday.

By Rebecca Pifer • March 5, 2020

Uber Health targets provider pain points with revamped platform

The ride-hailing giant is attempting to address gripes with its non-emergency medical transportation service through a handful of new features that began rolling out late last year.

By Rebecca Pifer • March 4, 2020

Element Science raises $146M to fund rival to Zoll's wearable LifeVest

Deerfield Healthcare and Qiming Venture Partners USA led the round, joining investors Third Rock Ventures and Google Ventures​ to bring to market Element's wearable defibrillator.

By Nick Paul Taylor • March 4, 2020

Livongo tops Q4 estimates with contributions outside of diabetes

In its third quarterly earnings report since going public in 2019, the digital health company said its total diabetes members doubled from a year ago and its hypertension and pre-diabetes platforms are gaining traction.

By Susan Kelly • March 3, 2020

California's new cybersecurity law sidesteps most medical devices, lawyers say

How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.

By Fred Donovan • Feb. 28, 2020

Joint FDA, industry real-world evidence center issues research frameworks

As real-world evidence gains momentum as a tool for assessing medical device safety and effectiveness, NESTcc is laying out guiding principles on research methods and ensuring data quality.

By Amritpal Sandhu-Longoria • Feb. 27, 2020

AI clinical documentation player Nuance preps for nationwide expansion

The technology, built in partnership with Microsoft, includes a wall-mounted device with microphones and other multi-sensory capabilities to record patient interactions and upload them into the EHR.

By Rebecca Pifer • Feb. 25, 2020

Most large hospitals embrace patient-facing digital tools despite cost concerns

A new survey from the Center for Connected Medicine found digital tools helped healthcare professionals manage simple tasks like accessing health records, making appointments and paying bills.

By Hailey Mensik • Feb. 19, 2020

Hospitals, clinics most likely to be hit with ransomware attack

But medical testing and supplies companies weren't spared among the 172 individual attacks from 2016 to 2019 that affected 6.6 million patients. 

By Shannon Muchmore • Feb. 11, 2020

VA facility claimed as 'world's 1st' 5G-enabled hospital

The Palo Alto Health Care System's 5G infrastructure — the fifth generation of cellular mobile communications — will be operational this week, VA Secretary Robert Wilkie said Wednesday.

By Rebecca Pifer • Feb. 6, 2020

Epic takes top award in KLAS survey for 10th year

In imaging, Philips led in the cardiology category, followed by Siemens, Fujifilm and IBM Watson Health.

By Ron Shinkman • Feb. 4, 2020

Major conglomerates 3M, GE, Philips bet on healthcare

The corporate giants' earnings reports this week indicate medical segments are increasingly important to strategy as other businesses decline.

By Nick Paul Taylor • Jan. 30, 2020

FDA clears Eko's stethoscope algorithms for AFib, heart murmur screening

The authorization gives primary care physicians an enhanced tool to screen for serious heart conditions, with the aim of speeding diagnosis and treatment.

By Susan Kelly • Jan. 29, 2020

Patient advocates urge quick release of final interoperability rules

The push comes on the heels of a campaign against the rules from Epic CEO Judy Faulkner, who has argued they threaten patients' privacy and would allow third-parties access to their data without consent.

By Samantha Liss • Jan. 27, 2020

Health AI startups netted a record $4B in funding last year

That's a nearly 50% jump in cash from 2018, which saw almost $2.7 billion across 264 deals, according to CB Insights.

By Rebecca Pifer • Jan. 23, 2020

Medical device sales flat, J&J CEO promises big year for robots

A Medical Device Business Review Day scheduled for this spring in New York City will feature "tangible evidence of not only the machines, but also the digital platform component," Alex Gorsky said of J&J's robotic surgery ventures.

By Nick Paul Taylor • Updated Jan. 23, 2020

Health IT to lead 2020 deals, KPMG predicts

The repeal of the medical device tax could boost investor interest in hot areas like non-invasive diagnostics, robotic surgery and AI-enabled devices, although health IT, pharma and biotech appear to be drawing more excitement.

By Linda Wilson • Jan. 15, 2020