Tag Archives: Compliance

Procept Biorobotics, a company at the forefront of developing advanced treatments for urological conditions, has recently been granted FDA approval to initiate a pivotal trial using its innovative aquablation therapy for treating prostate cancer. This technology, which employs a robot-assisted stream of fluid to precisely remove problematic prostate tissue, has already been in use for […]

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The integration of Artificial Intelligence (AI) and Machine Learning (ML) into medical devices has seen a dramatic increase over the past decade, facilitated by advancements in connectivity and technology as well as significant investments in AI capabilities. According to the Food and Drug Administration (FDA) database, 950 AI or ML-enabled devices were authorized up to […]

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Mercury Medical has initiated a recall of 1,300 Neo-Tee T-Piece Resuscitators used to provide emergency breathing support to newborns and infants through a face mask or a tube. The recall was prompted by a manufacturing issue that could potentially lead to a detachment of the inline controller, which is critical for adjusting and monitoring airway […]

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As the 2024 election approaches, significant matters such as abortion rights and drug pricing loom large over the healthcare sector. At the Reuters Total Health Conference in Chicago, Ceci Connolly, CEO of the Alliance of Community Health Plans, outlined five key points regarding how the upcoming election could impact healthcare. Election Dynamics Former President Donald […]

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The Centers for Medicare and Medicaid Services (CMS) is assessing the possibility of establishing a national Medicare reimbursement policy for a transcatheter repair procedure specifically designed to treat tricuspid valve regurgitation, following a formal coverage analysis request submitted by healthcare company Abbott. This procedure, known as tricuspid valve transcatheter edge-to-edge repair (T-TEER), utilizes Abbott’s recently […]

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AstraZeneca, a major pharmaceutical company, has recently expanded its cardiovascular drug portfolio by securing the rights to a promising new drug designed to combat dyslipidemia, a condition characterized by abnormal cholesterol levels. This deal involved an agreement with CSPC Pharmaceutical Group, based in Hong Kong, which could see AstraZeneca paying up to $1.92 billion in […]

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Smiths Medical, now part of ICU Medical since a 2022 acquisition, has encountered multiple safety issues, notably leading to the recall of several of its products. Recently, the company has been embroiled in a serious matter involving the recall of their portable ventilators – specifically the PneuPAC ParaPAC Plus P300 and P310 models. These events […]

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The Food and Drug Administration (FDA) has granted approval for Exact Sciences’ Cologuard Plus, an upgraded version of its existing stool-based test for colorectal cancer detection. The company announced that the new test, which boasts higher specificity than its predecessor, is expected to be launched with Medicare coverage and guideline inclusion by 2025. Although Exact […]

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Receiving a cancer diagnosis, such as breast cancer, starts with a profound shock and is quickly followed by a paralyzing fear regarding the uncertainty of treatment and the future. This initial emotional turmoil is compounded by the daunting task of communicating the news to family members, particularly children. A cancer diagnosis not only entails a […]

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The 340B program, designed to aid underserved communities by allowing eligible healthcare entities to purchase medications at substantial discounts, is facing controversy due to perceived expansive growth and lack of oversight. Pharmaceutical giant Johnson & Johnson (J&J) recently proposed a significant change in how two of its drugs, Stelara and Xarelto, would be priced under […]

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