Digital Health
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Exec Chat: A Conversation With The Program Manager Of The World Health Data Hub
WHO Health Data Hub Program Manager Jean-François Saint-Pierre spoke to Medtech Insight at HIMSS24 about creating and maintaining the health data set.
Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules
Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions.
Day 2: IMDRF Guidance Documents In The Works
Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.
In Five Years, People Will Navigate Their Health Care With An AI Advisor – Verily’s Andrew Trister
The digital “agent” on the horizon will draw on users’ entire health record, data from wearables and other sources to steer them in making health decisions. In this second part of a two-part series, Andrew Trister, chief scientific officer and chief medical officer at Verily, discusses his vision for the future and current obstacles.
Verily’s Andrew Trister On Uniting The Pieces To Create Personalized Health, Equity
Andrew Trister, Verily’s chief medical and scientific officer sat down with Medtech Insight during the recent ViVE conference to talk about how Verily is leveraging AI to address public health issues and global health inequities and the new web-based version of the Onduo platform, the use of GLP-1s to combat chronic diseases, and more. This is the first part of a two-part series on Verily.
Medtech Connect Episode 13: Augmented Reality In Surgery
In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements.
Identifying The Barriers To Digital Clinical Trial Technologies
Digital clinical trials, a trend sparked by the COVID-19 pandemic that has held the biopharma industry’s interest, are changing the way patients interact with research and improving access, says Medable’s CEO.
Interoperable Europe Act Promises Digital Cooperation Between Member States
The Council of the EU has adopted the Interoperable Europe act for more efficient digital public services across the EU. The act will apply to European common data spaces, including the European Health Data Space.
New’s We’re Watching: J&J's Varipulse PFA Earns CE Mark; Labs Create Intravascular Robots; And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, Biosense Webster’s Varipulse PFA platform earned a CE mark; Biosense Webster also announced the start the pivotal IDE study of its Laminar left atrial appendage elimination system; the FDA approved Boston Scientific's Agent paclitaxel-coated balloon and cleared Medtronic's OsteoCool 2.0 bone ablation system; three papers in Science Robotics describe magnetically controlled vascular robots that could go places wires and catheters cannot.
EHDS Regulation Needs To ‘Better Serve’ Its Intended Purpose
Trade association COCIR has released a list of five key recommendations that it says will “provide legal clarity” around the implementation of the EU European Health Data Space Regulation.
Cardio Conversations: ‘Much More Than Just A Patch,’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.
News We’re Watching: New Cybersecurity Standard; CMS Prodded On TCET; Olympus Scopes Recalled
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.
ViVE 2024: Start-Ups Using AI To Screen Children’s Mental Health, Prevent Post-Partum Depression, Health Equity, More
Medtech Insight features seven start-ups that pitched their innovative projects at ViVE’s inaugural Start-up Competition in Los Angeles.
Federal Government Takes Action To Protect American Data
The Biden administration issued an executive order to protect American data privacy. On the same day, the Senate HELP committee released its report on health data privacy with suggestions to update HIPAA for a modern healthcare world.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.
AdvaMed Principles For Artificial Intelligence Focus On Patient, Physician Needs
AdvaMed’s principles for artificial intelligence deb focus on using the technology to meet patient needs.
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