CES 2025: Neurotech Thought Leaders, Innovators Discuss Future Of AI-Driven EEG Headphones, Neural Earbuds To Monitor Brain Health, Diagnose Disease

 
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Medtech Insight brings you the highlights from two panel discussions at CES 2025 featuring innovators in the neurotech space discussing opportunities, challenges and ethical considerations in developing AI-driven solutions for the brain, and what lies ahead.

Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push, UK Pilots

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

When It Comes To Spine, Incumbents Are ‘Not Listening To Surgeons,’ Says Spineart CEO Jerome Trividic

 

Jerome Trividic, CEO of Swiss company Spineart, believes that by solving pain points felt by orthopedic surgeons performing spinal procedures, it can improve patient outcomes. He thinks the firm’s innovative approach, which focuses on partnership deals as well as developing its own products, will give it a competitive edge in the spinal surgery market.

Looking Back At Trump’s First Term Could Help The Medtech Industry Prepare For His Second

 

The medtech industry played a pivotal role in the first Trump administration, most notably during the COVID-19 pandemic. But the sector was also impacted by the administration’s deregulation push and trade posture towards China, including tariffs. So, should stakeholders expect more of the same in a second Trump term, or brace for uncertainty and change?


Bayer Expands Into IBS Market With HiDoc Technologies Acquisition, Cara Care App

 
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Bayer Consumer Health snaps up digital therapeutic Cara Care for its Precision Health business with an eye to developing its self-care capabilities.

Penetration Testing Strengthens Medical Device Security Against Emerging Threats

 
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Penetration testing, which involves ethical hackers identifying vulnerabilities before malicious actors can exploit them, is crucial for securing medical devices against cyber threats. The process is essential for compliance with regulations, preventing financial losses, and ensuring patient safety, cybersecurity experts say.

Deloitte 2025 Life Sciences Outlook Report Finds Medtech Leaders Focus On AI, GenAI Adoption Across Value Chain To Increase Efficiencies, Cut Costs

 
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The Deloitte 2025 Life Sciences Outlook report highlights cautious optimism among life sciences and medtech executives, with 75% expressing confidence in revenue growth despite challenges. AI and digital transformation are central to their strategies, enabling cost savings and operational efficiencies. Medtech Insight also spoke with Deloitte’s US Consulting Medtech Practice Leader, Sheryl Jacobson, about her medtech outlook for 2025.

Public-Private Partnerships Praised Amid Criticism of COVID-19 Response

 
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A US House Oversight Committee report criticizes the government's COVID-19 response, including PPE shortages and issues with the CDC’s test development process. However, it praises the successful public-private partnerships in developing diagnostics, emphasizing the importance of leveraging private industry expertise for future pandemic preparedness.


Stakeholders Weigh In On UK’s Clinical Trials Diversity Draft

 
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As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.

When It Comes To Stroke Care, Spanish Start-Up Embodies ‘Time Is Brain’ Medical Principle To Save Neurons And Lives

 
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Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.

News We’re Watching: Schwarzenegger ZB’s Chief Movement Officer; J&J Ottava Enters Clinical Trials; Dassault, FDA Develop First Guide For Virtual Twins

 

This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.

Harbinger Health Enters New Collaboration With MSK On Validation Trials, Presents New Data

 
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Massachusetts-based Harbinger Health has partnered with Memorial Sloan Kettering Cancer Center in New York to accelerate the validation of its AI-driven blood test for early-stage cancer detection. The company also recently presented encouraging data at two conferences.


La French Touch: How France Has Built a Reputation for Excellence In Medtech

 

France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.

Genetic Testing Company 23andMe Cuts 40% Of Workforce, Discontinues Drug Development Business

 
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23andMe cut 40% of its workforce and will discontinue its therapeutic program as part of ongoing restructuring. This comes after a data breach, series of layoffs and the resignation of its board members.

Octave Bioscience’s Multi-Biomarker Test Provides Key Insights To Predict Multiple Sclerosis Disease State

 
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Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HLTH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.

Advisory Panel Recommends FDA Approve Marketing Authorization For Novel Breast Cancer Treatment

 

The US FDA’s advisory panel on general and plastic surgery devices voted in favor of agency approval for a novel medical device for treating early stage, low-risk breast cancer as a potential alternative to lumpectomy. The agency is expected to make its decision on the device early next year.


Digital Health Roundup: GE HealthCare On AI At HLTH; Medtech Conference Panel; Graphene Brain Implant; Unicorns & More

 

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.

GlucoModicum’s Magnetohydrodynamic CGM Platform Moves Closer To The Clinic

 
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The company has taken the ambitious approach of establishing a manufacturing base capable of producing millions of devices before any attempt at a regulatory submission.

Esprit BTK Shows Fewer Repeat Interventions Than Balloon Angioplasty

 
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Patients treated with Abbott’s Esprit BTK system had better results and fewer repeat procedures after two years than a control group, the company announced this week. Abbott vascular leader Jennifer Jones-McMeans spoke with Medtech Insight about what the results could mean for patient care.

News We’re Watching: HistoSonics Secures $90M VA Deal, CRC Blood Test Deemed Less Cost-Effectiveness, More

This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.