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Positron Corporation is a nuclear medicine healthcare company specializing in the field of cardiac Positron Emission Tomography (PET) imaging. With over 30 years of focus on cardiac PET, Positron aims to make this superior modality more accessible to clinicians and patients worldwide. Their Attrius® system, optimized for MPI, offers cutting-edge technology and accurate diagnostic capabilities in cardiac imaging.
Positron Corporation (OTC: POSC) has entered a Clinical Study/Research Agreement with Ochsner Clinic Foundation for its new Affinity™ PET-CT 4D device. This agreement facilitates the collection of safety and efficacy data, crucial for obtaining an Investigational Device Exemption (IDE) from the FDA. The independent Institutional Review Board has approved all study procedures, allowing preparations for patient scans to begin post-IDE approval. The company aims for completion of the clinical study and FDA certification within 60 days, marking a significant step toward commercialization.
Positron Corporation (OTC: POSC) announces a collaboration with Dr. Robert Bober and Ochsner Health for a clinical study of its new Affinity PET-CT 4D imaging device. This FDA-compliant study, commencing mid-January 2023, aims to evaluate the device's image quality and performance in cardiac PET imaging. Dr. Bober's leadership is pivotal for gathering empirical data essential for marketing the system. Following completion and FDA 510k certification, Positron intends to commercialize the device in Q1 2023, targeting nuclear cardiology and oncology markets.
Positron Corporation (OTC: POSC) has announced the purchase of its first Affinity PET-CT system from Neusoft Medical Systems, which is currently in transit to the U.S. for validation. This marks a crucial step in launching the device, aimed at cardiac and oncology imaging. The company plans to reveal details about participating hospitals and expects to submit a 510K application to the FDA soon. President Adel Abdullah highlighted the excitement among industry partners for the upcoming validation studies, set to begin in September and conclude by November 2022.
Positron Corporation (OTC: POSC) announced the appointment of Christopher Reilly to lead its PET-CT Services and Systems Sales. With over 30 years of experience in SPECT imaging, Reilly aims to facilitate the transition from SPECT to PET imaging for hospitals and cardiology practices. The company will validate its new PET-CT device in collaboration with a leading healthcare organization over the next three months. President Adel Abdullah expressed confidence in Reilly's expertise, which is expected to support Positron's sales and marketing initiatives as it prepares to launch its new product.
Positron Corporation (OTC: POSC) announced its partnership with Medical Device Academy (MDA) to assist in the 510K submission for its new PET/CT device to the FDA. The company aims to file the application within 60 days, seeking approval within 100 days of filing. President Adel Abdullah highlighted MDA's expertise as crucial for the application process. This advancement is part of Positron's strategy to enhance cardiac and oncology diagnostics, positioning its innovative PET technology to meet market demand.
Positron Corporation (OTC: POSC) has announced a collaboration with Neusoft Medical Systems to develop a new PET/CT imaging system, marking a significant expansion into the oncology market. The company plans to submit a 510K application to the FDA soon. With an expected market size of $3.34 billion by 2028, Positron aims for a 10% market share. The new system promises superior imaging capabilities, thus enhancing diagnostic accuracy in nuclear cardiology and oncology. Positron emphasizes growth through transparency and is focused on expanding its marketing and sales efforts in the healthcare sector.
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