Featured Stories
GlucoTrack’s CEO Wants To ‘Keep Pushing The Boundaries’ With Implantable CGM
Israel-based CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.
Latest Designation Of Italian Notified Body Brings EU Total Under Medical Device Regulation To 47
EU announces the third designation under the MDR in a month.
Medtech Connect Episode 15: Digital Trust
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
To Be (a device) Or Not To Be. That’s The Legal Question
Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.
Spotlight On Conferences
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.
‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care
A More Cautious Approach To AI, And Other Policy And Regulation Trends From HIMSS 24
Creating Standards For Responsible AI In Health Care
Imagining Cybersecurity As An Ecosystem: From Regulations To Resiliency
Latest News
Medtech Insight Podcasts
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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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Global Device Regulation
A Collective Vision For UK Industry: 10-Point Medtech Manifesto
With much at stake as the UK closes in on national elections, healthtech manufacturers have issued their own manifesto setting out how political leaders can be winners for patients and industry.
Warning Letters And Close-Outs – April 2024
The US Food and Drug Administration released eight warning letters and one close-out last month. Big names caught in the net included Beckman Coulter, Royal Philips and Cardinal Health.
US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation
Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.
Netherlands Pilots New Scientific Advice Service For Clinical Trials
The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.
Digital Health
US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation
Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.
Apple Watch Feature Qualified As FDA Device Development Tool
The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.
Senseonics Wins Marketing Authorization For Novel Insulin Delivery System
The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.
Digital Health Roundup: US FDA’s ‘Idea Lab’; Philips’ Roy Jakobs On AI Draft Framework; Apple Watch
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.
Interviews
Medtech Connect Episode 15: Digital Trust
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.
GlucoTrack’s CEO Wants To ‘Keep Pushing The Boundaries’ With Implantable CGM
Israel-based CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and develop new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.
To Be (a device) Or Not To Be. That’s The Legal Question
Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.
Expert Proposes AI Device Reimbursement Model ‘Like Netflix’
Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement.
Podcasts
Digital Health Roundup: US FDA’s ‘Idea Lab’; Philips’ Roy Jakobs On AI Draft Framework; Apple Watch
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.
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.
Recent Stories
A Collective Vision For UK Industry: 10-Point Medtech Manifesto
With much at stake as the UK closes in on national elections, healthtech manufacturers have issued their own manifesto setting out how political leaders can be winners for patients and industry.
Warning Letters And Close-Outs – April 2024
The US Food and Drug Administration released eight warning letters and one close-out last month. Big names caught in the net included Beckman Coulter, Royal Philips and Cardinal Health.
US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation
Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.
Netherlands Pilots New Scientific Advice Service For Clinical Trials
The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.
MHRA Sets Out Summer Schedule Of Medtech Regulatory Milestones
UK devices regulator signals near-term progress on PMS statutory instrument, policy statement on international recognition and input into IMDRF project to update global diagnostics guidance.
Apple Watch Feature Qualified As FDA Device Development Tool
The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.
Expert Proposes AI Device Reimbursement Model ‘Like Netflix’
Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement.
Robotic-Assisted Treatment For Enlarged Prostate Shows Promising Results
A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.
GE HealthCare’s New Investigational MRI Promises Advancements On Neurological Disease Research
GE HealthCare announced today a new investigational MRI, which will be used in collaboration with researchers at Boston’s Brigham and Women’s Hospital, promises to help researchers better understand complex neurological diseases.
‘Dark Money’ Casts Shadow As Industry, Legislators Push For Litigation-Funding Transparency
AdvaMed is hopeful that legislation at the US federal and state levels will temper third-party litigation funding, which is wreaking havoc on the judiciary system and fostering mistrust of medical devices, it says.
ORA’s Chief Says Without Additional Funding, Inspections Are In Jeopardy
Without additional funding from Congress, the FDA’s ORA is facing challenges in retaining and hiring new staff, which will impact inspections, said ORA’s chief Michael Rogers during a webinar.
News We’re Watching: Philips Settles Recall Fallout; FDA REdI, Townhalls, Approvals
This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.
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