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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.
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.
UK MHRA’s Strategic Approach To AI Will Be ‘Proportionate’ And Fit Well Internationally
UK pursues light-touch regulation as it forges ahead with its own approach to regulating AI but with one eye on international convergence.
ICER Debuts Clinical Trial Diversity Assessment Framework
The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.
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
Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden
Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”
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.
Global Medtech Guidance Tracker: April 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.
Front Line Medical Technologies Announce CE Mark For COBRA-OS
Front Line Medical Technologies Inc.'s new CE marking expands access of its occlusion device COBRA-OS to medical providers in Europe. Adam Power, chief medical officer at Front Line Medical, talked to Medtech Insight about their marketing plans and benefits of the technology.
Digital Health
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.
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.
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.
Interviews
ICER Debuts Clinical Trial Diversity Assessment Framework
The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.
Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden
Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”
CDRH’s AR/VR Home Space Will Serve As An ‘Idea Lab’ For Device Stakeholders
The US FDA’s new initiative to create an idea lab for medical device use at home will benefit device manufacturers, patients and policymakers alike.
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.
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
Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden
Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”
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.
Liquid Biopsy Company Karius Raised $100M To Expand Its Test For Detecting Over 1,000 Pathogens
Karius announced on 2 May that it has raised $100m in a series C round of financing co-led by Khosla Ventures and new investors 5AM Ventures and Glide Ventures. The proceeds will be used to expand the firm’s reach beyond the 400 US hospitals where its Karius Test for detecting over 1,000 pathogens is already being used.
Global Medtech Guidance Tracker: April 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.
Front Line Medical Technologies Announce CE Mark For COBRA-OS
Front Line Medical Technologies Inc.'s new CE marking expands access of its occlusion device COBRA-OS to medical providers in Europe. Adam Power, chief medical officer at Front Line Medical, talked to Medtech Insight about their marketing plans and benefits of the technology.
Recalls Round-Up: Class 1s For BioMérieux, Fresenius, Draeger, More
A spate of recalls released in recent days follow problems with antibiotic test kits, dialysis tubing, an anesthesia system and infusion pumps. About 4,000 complaints have been reported tied to the recalls.
New Guidance For Breast Cancer Screening Drops Age Of First Scan To 40
New guidelines for breast cancer screening age and frequency have been lowered to align with standards from the American Cancer Society, but there are still debates over some of the recommendations.
CDRH’s AR/VR Home Space Will Serve As An ‘Idea Lab’ For Device Stakeholders
The US FDA’s new initiative to create an idea lab for medical device use at home will benefit device manufacturers, patients and policymakers alike.
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.
EU Regulatory Roundup, April 2024: EU On Cusp Of Regulatory Shifts Amidst Political Change
There are new EU regulations on medtech’s horizon following votes this month by the European Parliament. There are also unknowns when it comes to future leadership and the direction it will take as industry advocates for much-needed change.
Abbott Receives FDA Approval For Esprit BTK Drug-Eluting Resorbable Scaffold
The US has greenlighted Abbott’s Esprit BTK System for treating patients with chronic limb-threatening ischemia below the knee, making it the first dissolvable stent to treat this condition. A Wells Fargo analyst sees a $500m US market opportunity for the implant, which will see limited release in late 2024.
It’s Official: FDA Drops Final Rule On LDTs
After much anticipation, the US FDA is set to publish its controversial final rule for regulating laboratory developed tests, which places the tests under the same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.
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