Neurology

CES 2025 Roundup: AI-Powered Cameras Detect Asthma, COPD, Diabetes; Spit Reveals Stress Hormone Levels; Perimenopause Symptoms Revealed

 
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In this first of a two-part series from CES, Medtech Insight tunes into two companies that developed AI-powered cameras to detect respiratory diseases and chronic diseases respectively, two companies offering at-home testing for cholesterol, and a saliva test to help detect symptoms of perimenopause.

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.

FDA’s First ‘Early Alert’ Under New Communications Pilot Targets Fresenius Infusion Pumps

 

The US FDA has issued its first communication as part of a new pilot program the agency initiated to increase transparency in recalls of high-risk medical devices. The early alerts are meant to minimize the time between the FDA finding out about a potential issue and informing stakeholders.

Boston Scientific’s Head Of Urology Says Axonics Acquisition ‘Brings A More Comprehensive Gender Balance’

 
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Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.


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.

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.

FDA Adds Devices To Breakthrough Program, Cardiology Devices Still Out Front

 

The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.


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.

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.

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.

7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

 
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Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.


FDA Drops Final Guidance On Safety Considerations For Neonatal Medical Products

 

The US FDA has published a final guidance document providing stakeholders with a framework for various safety evaluations they should consider when developing medical products for newborns, including devices. The guidance focuses on long-term evaluations of neurodevelopmental safety.

ML-Based Neuromodulation, Tele-Robotic Medical Imaging Among Octane Medical Innovation Forum Highlights

 
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Start-ups pitched a diverse deck of innovative technologies to three judges and an audience of potential investors, strategics and physicians at the Octane Medical Innovation Forum in Irvine, CA. Highlights include neuromodulation company Sinaptica Therapeutics, which won the competition for both “People’s Choice” and “Judge’s Choice.”

Marabio Systems Raised $19M In Series A For Blood Test To Detect Autism

 
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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.

Some Perspectives From Medtech Industry Leaders Heard At Octane OC

 
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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.


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.

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.  

Inbrain Has Sights On Parkinson’s Following First-In-Human Test Of Graphene-Based Implant

 
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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.

Synchron Announces Positive Results From Stentrode BCI Study, Plans For Pivotal Study

 
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After announcing positive results showing that its Stentrode BCI is safe in six patients, brain-computer interface company Synchron is planning a pivotal trial to eventually file for FDA approval.