Tag Archives: FDAcopilot

Femtech company Clue, known for its app focused on menstrual cycle tracking and reproductive health, has announced a new partnership with digital mental health provider Headspace. Through this collaboration, members of Clue Plus, Clue’s subscription service, will receive a 50% discount on Headspace subscriptions. This partnership aims to enhance the mental health and mindfulness support […]

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Pfizer and BioNTech are currently developing a combination mRNA vaccine targeting both COVID-19 and influenza, which has shown mixed outcomes in a key clinical trial. The study’s results met only one of the two primary objectives for demonstrating the vaccine’s ability to initiate an immune response, according to an announcement made by the companies on […]

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Expansion of Medical AI Technologies in Asia: Advancements and Collaborations Highlight In a significant move within the medical technology sector, South Korean company Heuron has announced a new distribution agreement to bring its advanced medical AI solutions to Thailand. This collaboration involves a partnership with Medhealth Informatics, a prominent AI software distributor in Thailand. Together, […]

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Stereotaxis, a company specializing in robotic systems for minimally invasive endovascular procedures, has recently achieved a significant milestone by securing the CE mark for its new robotic surgery system, GenesisX, in Europe. This approval is crucial as it allows the company to introduce its advanced technology to the European market. Additionally, Stereotaxis has submitted a […]

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The digital therapeutics company Big Health has recently achieved an important milestone with the FDA 510(k) clearance for SleepioRx, a digital therapeutic specifically designed to alleviate insomnia and enhance overall sleep quality. This 90-day digital treatment program addresses insomnia by focusing on the cognitive and behavioral aspects that contribute to the disorder, employing a foundation […]

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Globus Medical, a company specializing in musculoskeletal devices, recently received a warning letter from the FDA due to violations found at one of its facilities. The violations were primarily concerned with the company’s management of quality systems and their reporting of medical device-related incidents. These findings were revealed following a February and March inspection of […]

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Otsuka’s digital health subsidiary has launched Rejoyn, an innovative app-based treatment specifically developed for managing major depressive disorder (MDD). Available solely on prescription, Rejoyn complements existing medication treatments and features a six-week program that uses principles of cognitive behavioral therapy. The program includes video lessons and exercises to assist users in recognizing and managing their […]

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In the typical process of dispensing prescription medications, patients encounter a common scenario: they’re offered a brief consultation with the pharmacist and receive a bundle of printouts containing vital information about their medications. However, this information, crucial for understanding the purpose and side effects of their prescriptions, is often overlooked until the patient returns home, […]

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Dan Easton, a Principal at Unorthodox Ventures, recently shared his insights ahead of his role as a judge at the INVEST Pitch Perfect startup contest which will focus on pediatric mental health at the MedCity INVEST Digital Health conference in Dallas on September 18. Unorthodox Ventures has a strong track record in healthcare investing, with […]

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Medtronic recently announced that it has received FDA approval for its deep brain stimulation (DBS) technology to be used while the patient is under general anesthesia. This marks a significant development in the field of neurosurgery as DBS procedures—typically used to treat conditions like epilepsy and Parkinson’s disease—have been traditionally performed while patients are awake. […]

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