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BioWorld - Tuesday, July 8, 2025
Home » Authors » David Godkin

David Godkin

Articles

ARTICLES

 Swift Ray 1 developed by Swift Medical Inc

Multi-center study gives high marks to pocket-sized wound imaging device

Sep. 14, 2023
By David Godkin

Authors of a multi-center study welcomed results from a device that works with a smartphone or tablet to capture medical images for a more detailed understanding of infected wounds. By capturing heat produced by a wound and using bacterial fluorescence, the Swift Ray 1 developed by Swift Medical Inc., may help clinicians tell the difference between inflammation and a potentially dangerous infection.


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Ceribell mobile patient monitoring

Ceribell scores win with FDA clearance of bedside Claritypro

Sep. 6, 2023
By David Godkin
At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the Centers for Medicare and Medicaid Services. The clearance of Claritypro to diagnose ESE follows receipt of an FDA breakthrough device designation in two different categories in the past year, setting the stage, Ceribell CEO Jane Chao told BioWorld, for expanded access to critical seizure diagnosis technology.
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Imeka white matter tracking

FDA clearance, reimbursement codes greet Imeka’s white matter tracking tool

Aug. 24, 2023
By David Godkin
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024.
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Vielight treatment for long COVID-19

Recruitment underway for clinical study of PBM for treating long COVID-19

Aug. 21, 2023
By David Godkin
Recruitment underway for Toronto-based Vielight Inc. has commenced recruitment for a clinical trial in the U.S. to study how brain stimulation photobiomodulation (PBM) might mitigate long-term cognitive impairment from long Covid. The study intervention comes on the heels of Canadian approval of a device to treat the acute version of Covid, involving light emitting diodes (LEDs) placed inside the nasal cavity and on the chest to deliver near infrared (NIR) light to the body.
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A little intestinal fortitude sees Fractyl on track to reverse the root causes of T2D

Aug. 17, 2023
By David Godkin
Fractyl Health Inc. reported clinical updates on the Revita real world registry in Germany which has demonstrated clinical remission from type 2 diabetes (T2D) employing a device that resurfaces the duodenal mucosa, the innermost layer of the first portion of the small intestine, and a potential root cause of T2D.
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Venostent bioabsorbable wraps

Venostent rounds up $16M round to study bioabsorbable wraps for treating ESRD

Aug. 11, 2023
By David Godkin
Venostent Inc. has completed $16 million in series A financing to support a U.S. pivotal trial for bioabsorbable wraps designed to improve outcomes for hemodialysis patients suffering from end-stage renal disease (ESRD). This comes after Venostent was granted an FDA investigational device exemption (IDE) to begin its U.S. Selfwrap-assisted arteriovenous fistula study and breakthrough device designation of its technology awarded last year.
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Biosense Webster launches Optrell catheter to map complex cardiac arrhythmias

Aug. 10, 2023
By David Godkin
It's one thing to ablate a lesion to treat a cardiac arrhythmia “but you can’t ablate the right place if you don’t know where it is,” said Nikki Sidi, U.S. President of Biosense Webster Inc. Sidi was commenting on the July 24 U.S. launch of the high-density diagnostic Optrell mapping catheter with Trueref technology powered by its Carto 3 software.
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magnus-saint-neuromodulation-02Aug.jpg

First participants in study treated using Saint neuromodulation for severe depression

Aug. 2, 2023
By David Godkin
The first participants are being treated in a clinical trial assessing a neuromodulation system developed by Magnus Medical Inc. to treat depression. The system employs the recently FDA-cleared Saint neuromodulation technology that saw remarkable results in a clinical trial for treating major depressive disorder (MDD). The new Open Label Optimization (OLO) clinical trial is evaluating the effectiveness of this platform in conjunction with the medtech’s Magnus Neuromodulation System.
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Hyfe AI-driven remote patient monitoring program (RPM)

Hyfe touts AI-driven RPM program for monitoring chronic cough

July 27, 2023
By David Godkin
Deep learning algorithms are used to remotely monitor and track just about everything these days and now that includes ordinary and chronic cough. Hyfe Inc. has launched an AI-driven remote patient monitoring (RPM) program designed to monitor cough for a whole range of serious ailments at virtual hospitals, remote care and telehealth programs across the U.S.
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Prostate cancer cells

Study concludes AI-powered biomarker successfully predicts ADT benefits in fighting prostate cancer

July 20, 2023
By David Godkin
ArteraAI Inc. released data from a study it said validates the first-ever artificial intelligence (AI)-derived biomarker predicting the benefit of androgen deprivation therapy (ADT) for stripping prostate cancer of the testosterone it requires to grow.
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View All Articles by David Godkin

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