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Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.
New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.
Healthtech Responds To Providers’ Productivity, Workflow And Sustainability Concerns
Healthtech innovators are being asked by users and clinicians how technology solutions can increase health system efficiency and respond to concerns over staff shortages. Royal Philips’ Bert van Meurs fielded these questions at ECR 2024.
Global Regulators Home In On Regulatory Reliance, Propose Universal Framework
Regulatory reliance was the theme on Day one of the 25th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.
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.
‘Indomitable Spirit’ Spurs Incontinence Treatment Firm Axena
Axena Health recently secured a HCPCS code for its female incontinence device Leva. For CEO Eileen Maus, this is just the latest in a string of successes across the women’s health, or femtech, sector.
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.
FDA Set To Drop Final Rule On LDTs, Sends Draft To White House
The US FDA has delivered a draft of its final rule on regulating lab-developed tests to the Office of Management and Budget, signaling it could meet the White House’s expectation for publishing its final rule by April.
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.
Down To Earth: NASA Discoveries Advance Human Health
While the latest missions from NASA may seem like the stuff of science fiction, discoveries from outer space are not only unlocking the mysteries of the cosmos, but improving technologies used every day on Earth, including those in the medtech industry.
Change Of Plan: Medtronic Drops Ventilators, Keeps Monitoring, Forms New Unit
Medtronic will stop producing ventilators and combine the rest of its patient monitoring and respiratory interventions business into a new business called acute care and monitoring. The company had previously announced plans to divest all of the patient monitoring and respiratory intervention business.
FDA Clears AI Software Designed To Detect Early Signs Of Fatty Liver Disease
The US FDA has cleared an AI software diagnostic product from an Israeli firm designed to detect a type of fatty liver, which is often an early indication of serious liver disease.
AAOS 2024: Stryker’s Lisa Kloes On Triathlon Hinge Implant, myMako For Mixed Reality Surgery Support
Stryker is showcasing its latest innovation in knee revision surgery, the Triathlon Hinge implant, and preparing to introduce a new myMako app to surgeons for anytime visualization and review of patients’ Mako surgical plans using Apple Vision Pro or iPhone.
Identifying Optimal Use Cases For Generative AI In Health Care: DHIS West Panelists Share Views
Gen AI has enabled insurance provider Elevance Health to reduce the time needed for processing health system rosters from an average of 90 days to an hour, according to Ashok Chennuru, global chief data and insights officer at Elevance subsidiary Carelon Digital Platforms. Chennuru was one of four panelists at DHIS West to discuss gen AI’s present and future in health care.
eXeX Claims ‘World First’: Apple’s Mixed-Reality Headset Deployed As Logistics Tool In OR
The Apple Vision Pro mixed reality headset was used during several spine reconstruction surgeries along with surgical support software and mixed reality provided by eXpanded eXistence, the Orlando, FL-based startup announced on 6 February.
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