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FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot
The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices.
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EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise
During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.
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News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation
This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.
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Healthtech Leaders Discuss Impact (And Risks) Of Generative AI and AI In Health Care
AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.
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MedTech Forum: Experts Suggest Short And Long-Term Solutions To EU’s Innovation Crisis
After focusing on the severity of the EU’s regulatory innovation crisis, Medtech Insight now reports on discussions in Austria last month on a range of changes that could improve the outlook for cutting-edge products.
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MedTech Forum: Is Global Regulatory Convergence Needed To Address EU’s Slow Innovation Exodus?
Does the difference in the height of the respective regulatory bars for innovation in the EU and US matter? And how severe are the problems being created by companies choosing to launch new products outside the EU? Hear the views of speakers at the Medtech Forum in Vienna in this first section of a two-part report from a session at the conference on innovation.
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Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups
New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline.
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UK Medical Device Firm Owen Mumford Launches Pelvic Health Consumer Brand
UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.
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‘Is This Doomsday Concern, Or Is It Reality?’ Verily CMO On AI’s Future, Lightpath Metabolic, More
Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.
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Outdated Technology Keeping Surgeons From Operating At Their Best: Medtronic Report
Cutting edge technology could significantly enhance operating room efficiency, according to a new report from Medtronic. The problem, however, is that most ORs don’t have it.
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Implantica CEO On Potential New Standard Of Care For Treating GERD: RefluxStop
Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.
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AMR, UTI, Breathomics And 3D Printing Technology Innovators Profiled At BioWales 2024
Breathomics, UTI diagnosis and advanced wound healing innovations were among the center stage technologies at BioWales in London 2024. Hear from CEO John McKinley on Imspex Diagnostics' plans in embedded podcast.
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Radiologists Ask For AI-Focused Reimbursement Pathway
The pathway, which would be separate from breakthrough device reimbursement, would allow new AI technology to be reimbursed based on “clinical value and public stakeholder engagement.”
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Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage
Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.
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News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion
This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.
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Nexsen Targets Clinical And At-Home Markets With Rapid Diagnostic For GBS Infection
Australia-based Nexsen BioTech is developing StrepSure, a rapid lateral flow test for detecting Group B Streptococcus (GBS) infection in pregnant women. Designed to provide results within 15 minutes, with the potential to save "millions of babies’ lives,” StrepSure will be assessed in a 5,000-patient clinical trial targeted for summer 2025, which will support Australia and US submissions for market authorization. Thomas Hanly, Nexsen managing director, discusses.
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