Digital Health
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Blue Button 2.0 doubles developers to 1,200, but beneficiary uptake tiny
CMS Administrator Seema Verma tells MedTech Dive that 11 organizations have "production apps" in place using live data.
By David Lim • Oct. 15, 2018
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Health apps require robust regulatory approach: JAMA opinion
The current FDA framework to revamp software regs in the Pre-Cert program is too short on checks to safety and whether products improve outcomes, the authors said. The concerns echo those made by Senate Democrats.
By Susan Kelly • Oct. 15, 2018
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Amazon, Walmart patents highlight potential of biometric monitoring
The developments come as both companies ramp up their involvement in healthcare.
By Meg Bryant • Oct. 12, 2018
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Suki AI-based voice assistant tops 1K patient encounters a week
The health IT startup claims it can sharply drop the time spent on medical notes.
By Meg Bryant • Oct. 11, 2018
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Top Democrats question FDA Pre-Cert program safety, statutory authority
Concern that the agency may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition.
By David Lim • Oct. 11, 2018
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Remote patient monitoring cuts hospital admissions, ER visits, report finds
Heart disease and COPD are the most popular uses, but other less acute chronic conditions are starting to find traction with the technology, the industry and KLAS report found.
By Meg Bryant • Oct. 08, 2018
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Blackberry announces healthcare applications for Spark platform, blockchain ledger
The tech company also announced a secure, real-time software program to assist developers of connected medical devices.
By Meg Bryant • Oct. 05, 2018
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Fitbit rolling out Charge 3 with focus on sleep tracking
The wearables company said it will also go live with a beta version of its Fitbit Labs Sleep Score program in November.
By Susan Kelly • Oct. 05, 2018
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Survey shows gaps in digital health uptake despite enthusiasm
Two-thirds of doctors have no plans to adopt virtual visits or home monitoring in the near future, according to a new EY report.
By Meg Bryant • Oct. 04, 2018
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5 themes from The MedTech Conference
Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.
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Pathology ripe for digitalization, but obstacles remain, report finds
Fewer than 5% of providers have moved to full digital pathology services, according to Signify Research.
By Meg Bryant • Sept. 28, 2018
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Hologic acquires developer of breast cancer surgery marker
The company agreed to pay $125 million for Focal Therapeutics, the latest addition to its breast health product portfolio, two months after purchasing digital imaging systems maker Faxitron Bioptics in an $85 million deal.
By Susan Kelly • Sept. 28, 2018
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New IMDRF committee to tackle cybersecurity threats
The FDA device chief laid out takeaways from the group's Beijing meeting.
By Kim Dixon • Sept. 27, 2018
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Shuren: Funds needed to launch FDA Center of Excellence for Digital Health
The device center head's warning comes as Commissioner Scott Gottlieb stresses the importance that Congress keep investing in the FDA.
By David Lim • Sept. 27, 2018
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FDA's Patel touts promise of software precertification program
Despite concern from the Clinical Decision Support Coalition that FDA may not have the legal ability to launch the pilot, the agency says it will work through its current authorities.
By David Lim • Sept. 26, 2018
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EY warns stagnant R&D, data use threatens medtech growth
Medtech R&D investment of $15.9 billion remained "relatively unchanged" in 2017 — roughly $1 billion less than the $16.4 billion companies gave back to investors through share buybacks and dividends.
By David Lim • Sept. 24, 2018
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AI can identify lung cancer types in images, study finds
The program determined with 97% accuracy which images showed adenocarcinoma and those showing squamous cell carcinoma.
By Susan Kelly • Sept. 18, 2018
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Welltok acquires text-based messaging platform Wellpass
Wellpass customers include Medicaid managed care and other government programs.
By Meg Bryant • Sept. 14, 2018
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Epic, Nuance partner on voice assistance technology aimed at busy docs
The system is compatible with Epic's Rover and Haiku workflow apps and will allow physicians to get schedules, look up patient information and check lab results and medication lists.
By Meg Bryant • Sept. 13, 2018
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New Apple Watch adds FDA-cleared ECG application
Agency officials touted the clearance as heralding a new age of digital health. Still, risks include false positives and negatives, which could lead to unneeded procedures or misdiagnosis.
By David Lim • Sept. 12, 2018
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A call to make EHRs safer for pediatric patients
A viewpoint published in JAMA Pediatrics argues for a rigorous certification program for electronic health records used in pediatric care to prevent harm to young patients.
By Susan Kelly • Sept. 11, 2018
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AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test
The agency has granted the designation, which fast tracks review, to 83 devices as of the end of July.
By David Lim • Sept. 11, 2018
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Livongo adds continuous glucose data via Abbott's FreeStyle Libre
Gathering continuous glucose data is intended to help diabetes patients and their doctors personalize treatment and improve decisions about care.
By Susan Kelly • Sept. 07, 2018
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Life science CEOs see future in technology, disruption
A KPMG survey also showed that cybersecurity remains a major pain point, with 33% of executives calling it the top risk to their organization's growth.
By Meg Bryant • Sept. 06, 2018
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Deloitte joins with Vineti on cloud-based precision medicine platform
The effort combines Deloitte's analytics technology with the venture between Mayo and GE's cellular therapies software.