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PCCPs Can Help Speed Device Sterilization Changes, FDA Webinar Suggests
Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.
Marabio Systems Raised $19M In Series A For Blood Test To Detect Autism
Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.
EU’s Medtech Rules Are A 'Bureaucratic Monster,' European Parliamentarians Say
The European Commission’s proposed timeframe for revising the MDR and IVDR is far too long, Parliament believes, and is resulting in increasingly outdated products in healthcare establishments around European threatening patient care.
Podcast: Noticing Neffy – A ‘Transformative Treatment’ For Type 1 Allergies
Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, highlights the crucial unmet need for needle-free devices to treat type 1 allergic reactions, given challenges associated with current epinephrine injectors. Hear what’s next for the Neffy intranasal spray and ARS Pharmaceuticals.
Spotlight On Conferences
European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'
Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
‘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
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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
Get It Done In 100 Days: European Commission Told To Deliver On Revising Device Regulation
The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.
Some Perspectives From Medtech Industry Leaders Heard At Octane OC
The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.
Next 510(k) Third Party Review? Medtechs May Take Wait-And See Approach To PCCPs
Predetermined change control plans have potential to accelerate US FDA review timelines for device modifications, but visibility remains low as to whether the program is behaving as advertised and delivering efficiencies sought by sponsors. Joshua Oyster, partner in Ropes & Gray’s Washington, D.C. office, offers perspective.
Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50
Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.
Digital Health
Some Perspectives From Medtech Industry Leaders Heard At Octane OC
The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.
FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health
The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.
News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Research Finds AI Stethoscopes Detect Heart Failure Signs
The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.
Interviews
Podcast: Noticing Neffy – A ‘Transformative Treatment’ For Type 1 Allergies
Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, highlights the crucial unmet need for needle-free devices to treat type 1 allergic reactions, given challenges associated with current epinephrine injectors. Hear what’s next for the Neffy intranasal spray and ARS Pharmaceuticals.
Next 510(k) Third Party Review? Medtechs May Take Wait-And See Approach To PCCPs
Predetermined change control plans have potential to accelerate US FDA review timelines for device modifications, but visibility remains low as to whether the program is behaving as advertised and delivering efficiencies sought by sponsors. Joshua Oyster, partner in Ropes & Gray’s Washington, D.C. office, offers perspective.
Crossject Tackles Needle Phobia In Emergency Settings
Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.
Inbrain Has Sights On Parkinson’s Following First-In-Human Test Of Graphene-Based Implant
Spain-based Inbrain Neuroelectronics plans first-in-human study to show safety of its graphene-based technology in direct contact with human brain while also developing a second interface for treating Parkinson’s disease.
Podcasts
Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
Digital Health Roundup: Brain Talk On Seizures, Alzheimer's, Stress, Anxiety; Medtronic's OR Report; Health Care AI; UK Guidances
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room.
Medtech Connect 16: AI For Cross Border Regulation
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.
Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Recent Stories
Get It Done In 100 Days: European Commission Told To Deliver On Revising Device Regulation
The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.
Some Perspectives From Medtech Industry Leaders Heard At Octane OC
The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.
Next 510(k) Third Party Review? Medtechs May Take Wait-And See Approach To PCCPs
Predetermined change control plans have potential to accelerate US FDA review timelines for device modifications, but visibility remains low as to whether the program is behaving as advertised and delivering efficiencies sought by sponsors. Joshua Oyster, partner in Ropes & Gray’s Washington, D.C. office, offers perspective.
Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50
Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.
De Novo Clearance For HealGen Flu/COVID-19 Test
The US Food and Drug Administration has granted a de novo authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first over-the-counter flu test to be cleared outside the emergency use pathway.
FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health
The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.
Crossject Tackles Needle Phobia In Emergency Settings
Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.
EU's MDCG Releases Corrective And Preventive Action Plan Guidance For Notified Bodies
Just as manufacturers need to implement corrective and preventive action plans, so this is an essential part of how a notified body functions; new guidance explains how.
UK’s Healthcare AI Gets A Boost From Regulatory Innovation Office
Artificial intelligence and digital in healthcare are among four key scientific development areas that will benefit from the support of the UK Regulatory Innovation Office, the launch of which was announced by the government on 8 October.
Opinion: The Only Thing That’s Permanent in Life Is Change
The US Food and Drug Administration is undergoing seismic leadership changes, from the expected post-election departure of two-term Commissioner Robert Califf to the retirement of longtime Center for Devices and Radiological Health Director Jeff Shuren. What might the new management mean for the medtech industry? Silverman Group President and former FDAer Steve Silverman has some insight.
FTC’s New Commissioner ‘Dismayed’ By Agency Overreach
FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements.
UK Gets Behind PIM Database Plan And Tools For Improved NHS Medtech Adoption
Innovation in life sciences and UK NHS adoption of technology are high on UK’s political agenda in the post-election period. Projects at the MedTech Directorate and NICE, and support from the Office for Life Sciences, are playing into a renewed sense of optimism.
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