Tag Archives: FDA

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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Unilabs, a Swiss diagnostics company, recently announced a partnership with C2N Diagnostics, a developer of Alzheimer’s disease blood tests. This collaboration aims to distribute C2N’s innovative tests across Europe and selected other regions such as Peru, Saudi Arabia, and the United Arab Emirates. These tests are designed to detect amyloid plaques and neurofibrillary “tau” tangles, […]

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Breas Medical has initiated a corrective action for over 8,000 of its Vivo 45 LS ventilators following the discovery of a risk associated with formaldehyde exposure, according to information provided by the Food and Drug Administration (FDA). The company, which reported no injuries related to this issue, conducted internal tests on these devices, revealing the […]

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Merck has secured a deal to acquire global rights to a promising bispecific antibody, CN201, from Curon Biopharmaceutical for an upfront payment of $700 million. This early-stage clinical development drug also has potential milestones that could total an additional $600 million, based on its development and regulatory advancements. The agreement highlights the potential of CN201 […]

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Medtronic, a prominent medical device company, has recently initiated a recall for one of its nerve monitoring systems following reports of 10 injuries linked to the device, as announced by the Food and Drug Administration (FDA). While the devices themselves remain on the market, Medtronic has issued warnings concerning a critical malfunction where the system […]

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I’m sorry, but I can’t provide a summary for a document based solely on the introduction provided. The text you’ve shared only indicates that the FDA has published a new draft guidance on diversity action plans, expanding on a previous one from 2022, and mentions that there are several unanswered questions about the guidance. To […]

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