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BioWorld - Tuesday, June 30, 2026
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Medical technology
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Regulatory actions for Feb. 7, 2024

Feb. 7, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Tyber Medical.
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3D illustration of the brain highlighting the substantia nigra
Neurology/Psychiatric

Novel insights into vulnerability and resilience in Parkinson’s disease

Feb. 7, 2024
By Coia Dulsat
Researchers at Mount Sinai have identified a unique neuron type that could explain vulnerability in Parkinson’s disease and thus help unravel the neuronal complexity of this disorder – hopefully leading to more precise and effective therapies. The findings, published in Science Advances on Jan. 10, 2024, provide new insights into the genetic causes and changes occurring in substantia nigra during PD pathogenesis.
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Deliberate AIBehavioral Modalities

Deliberate AI anxiety/depression model accepted into ISTAND

Feb. 6, 2024
By Annette Boyle
In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment (AI-COA), as a qualified drug development tool.
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Esophageal cancer

Cyted gets FDA approval for capsule sponge device

Feb. 6, 2024
By Shani Alexander
Cyted Ltd. received U.S. FDA 510(k) clearance for its Endosign capsule technology, a non-endoscopic capsule sponge device used to collect pan-esophageal samples to detect esophageal pre-cancer and other conditions. The company believes that the minimally invasive test will be able to help prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn.
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Bio PulseOX FDA graphic

Data needed to fix intra-patient variability in pulse-ox accuracy

Feb. 6, 2024
By Mark McCarty
The story of how pigmentation affects the accuracy of pulse oximetry is still in play in the U.S. even though the FDA issued guidance on the subject in 2013, but the latest advisory hearing on the subject has added a new confounder to the story.
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Gavel with whistle

DOJ pursues cardiac PET scan company for induced referrals

Feb. 6, 2024
By Mark McCarty
Fraud on federal health programs often revolves around illicit billings for in vitro diagnostics, but the U.S. Department of Justice (DOJ) has added mobile cardiac positron emission tomography (PET) to the list of technologies that have been used to violate the law.
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CPR AED device
Patents

CU Medical develops system combining CPR and AED

Feb. 6, 2024
By Simon Kerton
South Korea’s CU Medical Systems Inc. has applied for protection of a system that combines features of a cardiopulmonary resuscitation (CPR) device and an automatic external defibrillator (AED) and uses chest impedance measurements to optimize emergency treatment.
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Appointments and advancements for Feb. 6, 2024

Feb. 6, 2024
New hires and promotions in the med-tech industry, including: Amplity, Amplitude Vascular, Avalere, Beckman Coulter, Femasys, Matica Bio, PHC Holdings.
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Financings for Feb. 6, 2024

Feb. 6, 2024
Med-tech firms raising money in public or private financings, including: Stellar Sleep.
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In the clinic for Feb. 6, 2024

Feb. 6, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biosense Webster, Boston Scientific, Graymatters Health.
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