Featured Stories
Small Sterilization Companies Poised To Meet EtO Emissions Goals On Time
Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026
Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.
Spotlight On Conferences
‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care
At the recent Precision Med Tri-Con conference, health care leaders and AI enthusiasts Eric Topol and Doug Flora discussed how AI integration will change the way doctors practice medicine and patients receive care.
Latest News
Medtech Insight Podcasts
This Episode:
Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia DiagnosticsListen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.
More PodcastsData Trackers
Global Device Regulation
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.
MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation
Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.
Digital Health
Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round
Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.
CDS Final Guidance Draws More Criticism, This Time From Congress
Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.
Alarming Rise Of Diabetes in Several US States, Study Shows
A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.
Interviews
Small Sterilization Companies Poised To Meet EtO Emissions Goals On Time
Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation
Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.
Alarming Rise Of Diabetes in Several US States, Study Shows
A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.
Podcasts
Medtech Connect 14: Live From HIMSS
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.
Digital Health Roundup: Impact Of EU’s AI Act On Device Makers; Verily's Andrew Trister’s Vision For Personal AI Agent
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.
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.
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.
Recent Stories
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round
Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.
MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation
Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.
CDS Final Guidance Draws More Criticism, This Time From Congress
Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.
Alarming Rise Of Diabetes in Several US States, Study Shows
A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.
GE HealthCare Launches AI-Powered Voluson Ultrasound For Women’s Health
Voluson Signature 20 and 18 ultrasound provides clinicians with workflow efficiencies in detecting female reproductive health problems, especially those related to pregnancy.
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