Month: September 2024

Sanofi is expanding its presence in the pharmaceutical industry by delving into the radiopharmaceutical sector, following the lead of other major pharmaceutical companies. The company has entered a licensing agreement to acquire AlphaMedix, a clinical-stage radiopharmaceutical therapy developed by RadioMedix and Orano Med, targeting a rare type of gastrointestinal cancer. Under the terms of the […]

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Corrective and Preventive Action (CAPA) is a fundamental process required by the FDA under 21 CFR 820.100 for medical device professionals. It serves to correct and prevent systemic issues in the production and management of medical devices. The CAPA requirement entails several key activities: Analysis of Various Data Sources: Medical device manufacturers must analyze data […]

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In recent times, diabetes technology has seen significant advancements, notably in the areas of continuous glucose monitors (CGMs) and insulin pumps. These developments have positioned this sector at the forefront of medical device innovation. A major highlight within the field is the approval and emergence of over-the-counter (OTC) CGMs, which has garnered considerable attention within […]

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Observational studies are experiencing significant shifts that necessitate a transformation in research approaches, particularly due to the arrival of groundbreaking therapies such as CAR-T cell therapies, which require long-term study over decades. Traditional site-based research models, which rely on patients regularly visiting clinical sites, are becoming impractical for such extended periods because of the high […]

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The landscape of medical device innovation is advancing at a rapid pace, challenging existing regulatory and quality assurance systems meant to ensure safety and efficacy. As device functionality and interoperability escalate, traditional methods used in design and production struggle to keep pace, leading to an increase in recalls and stricter regulatory scrutiny. To manage these […]

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Apple has announced significant new health-tracking features for its smartwatch and AirPods Pro 2, aiming to enhance its role in consumer health technology. The company revealed plans to introduce sleep apnea detection to its Apple Watch, along with hearing aid capabilities to its AirPods Pro 2. These updates follow Apple’s pattern of continually integrating advanced […]

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Smiths Medical, recently acquired by ICU Medical, communicated to customers on May 29 about a manufacturing flaw in some of their Bivona adult and pediatric tracheostomy tubes. This defect has the potential to cause the device to tear or become displaced, posing significant risks including “catastrophic adverse events.” This issue has unfortunately been linked to […]

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At the Heart Rhythm Society’s HRX conference in Atlanta, Maria Berkman, a notable venture capitalist in the medical technology (medtech) sector, shared valuable insights into the intricacies of medtech investment. Berkman, who operates as the head of medtech at Broadview Ventures and managing director at Longview Ventures, articulated that the landscape of medtech investment is […]

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At a recent virtual event, Apple introduced significant advancements in its product lineup, most notably the Apple Watch Series 10 and the AirPods Pro 2. Both devices come packed with new health and technology features aimed at vastly improving user experience and functionality. The Apple Watch Series 10 is set to revolutionize health monitoring with […]

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More than 40% of artificial intelligence (AI) tools cleared or approved by the Food and Drug Administration (FDA) from 1995 to 2022 lack clinical evidence, as highlighted in a recent Nature Medicine article. Researchers from the University of North Carolina School of Medicine studied 521 FDA-authorized AI medical devices, finding that 226 devices (~43%) lacked […]

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