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Valuable Health Data Sources For Medtech Industry Come A Step Closer In The EU
The only step that remains now before the European Health Data Space Regulation is approved is sign off by the Council of the EU, due next month. Industry wants to see the new framework carefully aligned with existing EU legilsation.
Australia Calls For Companion Testing Plans For Drugs Requiring A CDx
An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.
Epitel Gets 510(k) Clearance On Remote EEG Technology
The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.
Rise In Class I Device Recalls A ‘Grave Concern,’ Says FDA’s Anne Reid
The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.
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.
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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.
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Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch
People with Parkinson’s often face a “social toll” from the disease, so h2o therapeutics is focused on discreet solutions for the symptom of gait freezing that work with wearable devices.
Shuren Says CDRH Is ‘Turning The Ship Around’ As Operations Return To Normal
The director of the US FDA’s device center discussed several of the center’s priorities at Medcon, such as moving beyond the pandemic, focusing on patients, and advancing health equity.
EU: Good News For IVDs And For Future Transparency Of Medtech Compliance
The IVD industry has long been awaiting a further extension of the deadlines for compliance with the IVD Regulation and for the launch date of the Eudamed database to be brought forward.
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.
Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch
People with Parkinson’s often face a “social toll” from the disease, so h2o therapeutics is focused on discreet solutions for the symptom of gait freezing that work with wearable devices.
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.
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.
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.
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.
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.
Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch
People with Parkinson’s often face a “social toll” from the disease, so h2o therapeutics is focused on discreet solutions for the symptom of gait freezing that work with wearable devices.
Shuren Says CDRH Is ‘Turning The Ship Around’ As Operations Return To Normal
The director of the US FDA’s device center discussed several of the center’s priorities at Medcon, such as moving beyond the pandemic, focusing on patients, and advancing health equity.
EU: Good News For IVDs And For Future Transparency Of Medtech Compliance
The IVD industry has long been awaiting a further extension of the deadlines for compliance with the IVD Regulation and for the launch date of the Eudamed database to be brought forward.
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.
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 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.
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.
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.
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