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Sinaptica’s Breakthrough Device Could Slow Brain Atrophy In Alzheimer’s Patients – Study

Firm’s Is One Of Several FDA-Designated Breakthroughs Aiming To Outshine Drug Treatments

 
• By Ryan Nelson

In a pilot study building on previously published Phase 2 trial results, Sinaptica’s precision therapy, combining repetitive transcranial magnetic stimulation with EEG monitoring and artificial intelligence, showed macro- and micro-structural grey matter preservation and increased functional connectivity in Alzheimer’s patients versus a sham treatment arm.

Medtech on the Brain
• Source: Shutterstock

Medtech Insight is highlighting awareness for mental health, Alzheimer’s and brain health by speaking with industry leaders about rising innovations to address neurological diseases and mental health, the regulatory and investment climate, reimbursement, and more.

Sinaptica Therapeutics has unveiled preliminary study findings suggesting that its personalized closed-loop neuromodulation therapy could be used to arrest brain atrophy progression in Alzheimer’s patients.

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

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Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

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Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

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First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.