Tag Archives: FDAgpt

Medical device industry leaders are congregating in Toronto for The Medtech Conference hosted by Advamed, marking one of the sector’s most significant global assemblies. The conference boasts participation from over 3,900 individuals across 48 countries, focusing on the latest trends in medical technology and evolving global regulatory landscapes. This gathering occurs at a crucial juncture […]

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Lundbeck, a company focused on the development of neuroscience drugs, has announced its strategic acquisition of Longboard Pharmaceuticals in a deal valued at $2.6 billion. The acquisition highlights Lundbeck’s entry into the epilepsy market, particularly targeting a rare inherited seizure disorder with limited available treatments. Under the terms of the acquisition, Lundbeck will pay $60 […]

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The medical technology (medtech) earnings season has commenced with third-quarter results from leading companies such as Johnson & Johnson, Abbott, and Intuitive Surgical. These reports are particularly significant as they provide insights into the development of critical markets including pulsed field ablation (PFA), diabetes technology, and surgical robotics throughout the latter part of the year. […]

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Astellas Pharma, recognizing the urgent need for treatments in neurodegenerative disorders, has made a significant financial commitment to AviadoBio, a London-based biotech startup. The collaboration involves a $50 million investment focused on a pioneering gene therapy for frontotemporal dementia (FTD), a form of dementia that currently lacks any FDA-approved medications. This financial package includes a […]

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Upstream Bio, a biotech company specializing in severe asthma treatment, has successfully raised $225 million through their Initial Public Offering (IPO), thanks to promising clinical data on their lead drug, verekitug. Verekitug, a monoclonal antibody, targets the TSLP receptor, potentially offering better symptom management and less frequent dosing compared to AstraZeneca and Amgen’s Tezspire, which […]

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The development of infants encourages tummy time to strengthen muscles and promote motor skills, similarly, the integration of Artificial Intelligence (AI) into clinical practice is designed to enhance the expertise and situational awareness of clinicians. AI, akin to auditory cues in a vehicle that alerts the driver when they stray, offers real-time feedback that aids […]

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Scholar Rock, a biotechnology company, has recently showcased its experimental drug, apitegromab, which targets spinal muscular atrophy (SMA), a rare genetic disease characterized by progressively worsening muscle weakness due to mutations in the SMN gene important for motor neuron health. Unlike existing therapies, apitegromab focuses directly on combating muscle atrophy by inhibiting myostatin, a protein […]

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Most early-stage MedTech companies prioritize gaining market access, primarily seeking FDA approval to market their medical devices in the US. A common route for this pursuit is the 510(k) regulatory pathway. This pathway permits market entry if the manufacturer can demonstrate that their new device is substantially equivalent to a pre-existing device, known as a […]

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Technology is steadily transforming the landscape of medical device companies, particularly in how they manage quality control through their Quality Management Systems (QMS). As we march forward into the 21st century, a clear preference has emerged between traditional paper-based QMS and modern software-based solutions. The stakes are particularly high for growing MedTech businesses that cannot […]

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HLTH 2024 is set to take place from October 20-23 at the Venetian Expo Center in Las Vegas, featuring a diverse array of speakers including high-profile executives, healthcare experts, and celebrities. This event promises to cover a wide range of topics crucial to the advancement of healthcare. Andrea Willis, M.D., Chief Medical Officer at BlueCross […]

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