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June 30, 2022

US FDA grants expanded 510K clearance for MolecuLight’s i:X imaging device

MolecuLight i:X allows visualisation of regions containing bacterial species at the point-of-care.

The US Food and Drug Administration (FDA) has granted expanded 510(K) clearance for MolecuLight’s i:X imaging device to include the ability to identify wound regions containing elevated bacterial load as well as more bacterial species.

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The expanded labelling of MolecuLight i:X allows clinicians to detect wound areas with more bacterial species, including key target pathogens of interest to the Centers for Disease Control and Prevention (CDC) that are said to be major causes of antimicrobial resistance.

MolecuLight i:X can detect bacterial species, including anaerobes, aerobes, and gram-negative and gram-positive species.

The company stated that the expanded labelling of the imaging device is based on a detailed retrospective statistical analysis of more than 350 patients.

MolecuLight CEO Anil Amlani said: “We are thrilled with the FDA’s new clearance for MolecuLight’ ability to determine the location of elevated bacterial loads in wounds, in addition to the ability to identify regions with more bacterial species of interest.

“Clinicians worldwide are using the MolecuLight device to visualise regions with clinically significant bacterial loads and more species of concern.

“With point-of-care information on bacterial load and its locations through use of a MolecuLight device, clinicians can act immediately to tailor their cleaning, debridement, antimicrobial strategies and treatments accordingly.”

Using MolecuLight i:X, clinicians can focus on harmful bacteria with the guidance of fluorescence imaging.

The device can instantly detect and reveal the location of potentially harmful levels of bacteria, allowing for more targeted treatment protocols.

The company noted that the MolecuLight i:X imaging platform has received FDA de novo clearance and three additional FDA 510(k) clearances.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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