Digital Health: Page 29
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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 -
FDA
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 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 Parduhn • March 17, 2020 -
Logo: HIMSS Global Health Conference & Exhibition; Photos by José Martín Ramírez C/Unsplash; Abyabe/Wikimedia Commons. Photo illustration by Michelle Rock/Healthcare Dive.
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 Parduhn • March 5, 2020 -
Courtesy of Uber
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 Parduhn • 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 Parduhn • 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 Parduhn • 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 Parduhn • 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 -
Alphabet snaps up 2nd ex-ONC head for life sciences team
Vindell Washington is the latest in Alphabet's ongoing campaign to hire top healthcare talent as the Google parent company doubles down on the industry.
By Rebecca Pifer Parduhn • Jan. 10, 2020 -
Digital health M&A flatlines in 2019, but IPO activity promising
Rock Health sees creation of remote patient monitoring reimbursement codes, progress on data blocking rules and FDA's Pre-Cert program as potential growth catalysts for the sector.
By Nick Paul Taylor • Jan. 8, 2020 -
Latest FDA clinical decision support software draft a step forward, industry says
The American Medical Association wrote the guide could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."
By David Lim • Jan. 7, 2020 -
Jacob Bell/MedTech Dive
AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod
Digital health company Eko is working with the Mayo Clinic on an algorithm to detect reduced left ventricular ejection fraction, an indicator for heart failure, using a stethoscope during a routine physical exam.
By Susan Kelly • Dec. 19, 2019 -
Medtronic acquires meal detection tech to bolster personalized closed loop system
Klue's fine motor artificial intelligence software that can sense eating will help future diabetes management systems become hands free, the company said.
By Maria Rachal • Dec. 18, 2019
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