Digital Health: Page 2
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FDA revises clinical decision support software draft after industry blowback
The decision to revise the draft guidance comes after feedback on the 2017 version asked the agency to reconsider its approach, Bakul Patel, FDA's director for digital health, told MedTech Dive.
By David Lim • Sept. 26, 2019 -
To pitch Pre-Cert to Congress, FDA builds a case first
Enforcement mechanisms and the decision of how the experimental pathway will fit into the current 510(k), De Novo and PMA routes are among the details lawmakers will need to eventually address, an agency official said.
By Kim Dixon • Sept. 25, 2019 -
Medtechs keep shareholders happy, potentially at pipeline's expense: EY
The industry recorded its highest revenues ever within the last year, an analysis by the consultancy shows. Even as R&D spending grew 11%, those investments fell short of the proportion of cash returned to investors.
By Maria Rachal • Sept. 23, 2019 -
FDA creates agencywide tech modernization roadmap
The agency plans to spend the next one to two years upgrading its infrastructure to meet emerging data handling needs.
By Nick Paul Taylor • Sept. 19, 2019 -
Varian buys software developer for AI cancer work
The radiation oncology company is making an undisclosed investment in privately held Oncora Medical to collaborate on development of machine learning-based software.
By Susan Kelly • Sept. 16, 2019 -
FDA clears GE's AI-powered x-ray algorithms for triaging collapsed lungs
GE Healthcare said the technology will help hospitals identify high-priority cases and fast track treatment.
By Nick Paul Taylor • Sept. 13, 2019 -
Apple to start trio of research studies on hearing, heart and women's health
The studies, which will be organized through a new Apple Research app this fall, are being conducted in partnership with various universities, hospitals, associations and the U.S. government.
By David Lim • Sept. 11, 2019 -
FDA looks to define 'triggers' for medical device cybersecurity warnings
When do the benefits of notifying patients of potential risks outweigh possible harms? The agency's Patient Engagement Advisory Committee is weighing in Tuesday.
By Maria Rachal • Sept. 10, 2019 -
With partner iRhythm, Verily ramps up AFib efforts
iRhythm committed almost $18 million to Verily to boost development of technology that helps deliver earlier warnings to individuals with asymptomatic or silent atrial fibrillation.
By Maria Rachal • Sept. 05, 2019 -
Fitbit to wade into care management in pilot this year
The fitness tracker giant also announced it is launching a premium service and plans to develop wellness reports allowing users to share their data with their physician.
By Rebecca Pifer • Aug. 28, 2019 -
AllScripts touts deal with Apple Health Records
Despite reports of rising tensions and turnover among Apple's health team, the tie-up suggests the tech behemoth is still bullish on healthcare.
By Ron Shinkman • Aug. 23, 2019 -
Q&AQ&A: ONC chief Don Rucker on bringing the app economy into healthcare
"Most of our health data is actually not in the medical record or in HIPAA or even generated by providers. Most of the available inference on health is sitting in things like the GPS of our phone," the health IT chief told Healthcare Dive.
By Rebecca Pifer • Aug. 22, 2019 -
ONC in talks with Congress, White House on third-party health app privacy
National Coordinator for Health Information Technology Don Rucker said there is bipartisan interest in taking action.
By Rebecca Pifer • Aug. 21, 2019 -
Livongo a darling of one Wall Street firm a month after IPO
"The digital health field is littered with companies that have over-promised and under-delivered," analysts at SVB Leerink acknowledge, but they made the case the startup is different.
By Nick Paul Taylor • Aug. 20, 2019 -
Tidepool CEO talks Pre-Cert era, interoperability
Amazon and Pixar software veteran Howard Look spoke to MedTech Dive about working through FDA's software development evaluation pilot and the implications of an insulin dosing app that works with many brands' devices.
By Maria Rachal • UPDATED: Aug. 16, 2019 at 12:01 p.m. -
Healthcare AI funding hits new high as sector matures
Startups in the sector raised $864 million across 75 venture capital-backed deals and financing during the second quarter, beating the previous quarterly high by about $100 million.
By Nick Paul Taylor • Aug. 07, 2019 -
CMS pilot to give doctors patient Medicare claims data
CMS hopes to eventually roll out the initiative to all Medicare fee-for-service providers, giving doctors Medicare claims data for their patients, including prescribed medications, procedures, diagnoses and other providers.
By David Lim • July 30, 2019 -
Walgreens adds Dexcom, Propeller to digital marketplace
The collaborations are an expansion into chronic care management with connected devices for patients with diabetes, asthma and chronic obstructive pulmonary disease.
By Susan Kelly • July 24, 2019 -
Medtronic to distribute AI stroke detection and triage software
The technology comes from Google Ventures-backed artificial intelligence startup Viz.ai, which won a De Novo clearance last year for its clinical decision support software aimed at speeding identification of large vessel occlusions.
By Maria Rachal • July 22, 2019 -
Pear files insomnia and depression software as Pre-Cert pilot 510(k)
CEO Corey McCann told MedTech Dive he hopes the digital therapeutic will be cleared in the first half of 2020, but cautioned Pear has "a good deal of learning to do in terms of the FDA response to this specific submission."
By David Lim • July 19, 2019 -
Fertility apps hold promise, but less precise than conventional methods, study finds
A Nature journal analysis of data captured by the Kindara and Sympto apps led independent researchers to predict self-tracked results will support the quantification of infertility or daily pregnancy chances.
By Nick Paul Taylor • July 19, 2019 -
Fitch Solutions tips Roche to challenge Philips for digital pathology market
After enjoying a brief monopoly, Philips faces a clutch of competitors planning regulatory filings.
By Nick Paul Taylor • July 10, 2019 -
Insulin pen smart cap maker in talks to supply Sanofi
French medical device maker Biocorp's Internet-connected cap is designed to work with a conventional insulin pen and can automatically transmit dosage data to a smartphone app.
By Susan Kelly • July 08, 2019 -
As digital health investing matures, report says sector dodges a bubble
Venture fund and research firm Rock Health said the pace of investment dollars flowing into the sector may top 2018’s record funding as a digital health IPO drought appears on the verge of ending.
By Susan Kelly • July 02, 2019 -
Health tech IPO activity picks up with filings from Livongo, Health Catalyst, Phreesia
With its revenue more than doubling between 2017 and 2018, chronic disease management startup Livongo may break the drought of digital health IPOs.
By Maria Rachal • June 28, 2019
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