Neurology

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

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 HTLH 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

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

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

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

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

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

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

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

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

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

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

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.


Route 92 To Drive FreeClimb Neurointervention Sales With Extended Series F Funding

Route 92 To Drive FreeClimb Neurointervention Sales With Extended Series F Funding

 

An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.

Empowering Primary Care Physicians With Digital Biomarkers For Early Alzheimer’s Detection

Empowering Primary Care Physicians With Digital Biomarkers For Early Alzheimer’s Detection

 
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Altoida CEO Mark Jones has high hopes that the company’s digital assessment tool will be approved by the FDA to be used along with blood biomarker testing by primary care doctors to help predict Alzheimer’s disease before patients show symptoms.

Altoida’s Vision For Alzheimer’s Care Combines Digital Screening, Blood-Based Tests, New Drugs

Altoida’s Vision For Alzheimer’s Care Combines Digital Screening, Blood-Based Tests, New Drugs

 
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Altoida CEO Marc Jones spoke with Medtech Insight about the company’s investigational digital screening tool for Alzheimer’s and the dire need for better, more accessible precision neurology diagnostics as the global population ages, neurologist shortages worsen, and groundbreaking Alzheimer’s drugs change the treatment paradigm.

Medtronic Partners With Siemens Healthineers To Evolve AiBLE Spine Surgery Platform

Medtronic Partners With Siemens Healthineers To Evolve AiBLE Spine Surgery Platform

 
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The companies intend to co-market Siemens Healthineers’ Multitom Rax as part of Medtronic’s AiBLE ecosystem, which combines advanced technologies in navigation, robotics, imaging, data analytics, and AI to enhance the precision and predictability of spine and cranial surgeries.


Click’s Digital Therapeutic Shown To Enhance Clinical Benefit Of Migraine Drugs In Pivotal Trial

Click’s Digital Therapeutic Shown To Enhance Clinical Benefit Of Migraine Drugs In Pivotal Trial

 

Click Therapeutics reports positive Phase 3 clinical data for CT-132, a digital therapeutic intended as an adjunctive treatment of episodic migraine. The company is pursuing FDA clearance and actively exploring opportunities to offer a drug-digital combination therapy with added clinical benefit that provides “a single, integrated experience for the patient, prescriber and payer.”

LSX Medtech Panelists Talk AI, Market Access Strategies, Digital Therapeutics Reimbursement

LSX Medtech Panelists Talk AI, Market Access Strategies, Digital Therapeutics Reimbursement

 
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Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

Abbott Launches Trial Of DBS Depression Treatment

Abbott Launches Trial Of DBS Depression Treatment

 
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The DBS trial will look at the use of neurostimulation in people with treatment-resistant depression, which affects about 2.8 million Americans each year. The implanted device may relieve depression symptoms by changing activity patterns in the brain.

Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart

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.