Author: FDAcop

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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Samsung Medison, a medical device subsidiary of the South Korean tech giant, recently announced its acquisition of Sonio, a French medtech startup specializing in enhancing fetal ultrasound efficiency with AI. This acquisition marks a significant step for Samsung in deepening its footprint in the healthcare sector. Founded in 2020, Sonio has rapidly gained attention for […]

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NeOnc Technologies, a biotech company from Westlake Village, California, is pioneering a new method for treating aggressive brain cancers, such as glioblastoma, by circumventing the blood-brain barrier through intranasal drug delivery. The company’s primary innovation, NEO100, uses perillyl alcohol (POH), a natural compound found in essential oils, delivered directly to the brain via inhalation, targeting […]

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AI regulation in healthcare continues to be an evolving field that requires a focus on transparency and understanding, as emphasized by Luke Raston during a recent presentation at the Heart Rhythm Society’s HRX conference in Atlanta. Ralston, a seasoned biomedical engineer and scientific reviewer at the FDA, stressed that regulating AI is a nuanced process […]

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Eli Lilly is advancing its development of a once-weekly insulin, efsitora alfa, designed for people with diabetes, bringing it a step closer to competing with similar products like Novo Nordisk’s already available insulin icodec. As part of a comprehensive Phase 3 program which includes five studies — four focusing on type 2 diabetes and one […]

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Travere Therapeutics, a San Diego-based biotech company, has received full FDA approval for their drug Filspari, which treats immunoglobulin A nephropathy (IgAN), a rare disease where excessive antibody production leads to kidney damage. Previously granted accelerated approval based on its ability to reduce proteinuria—a sign of kidney disease—Filspari’s full approval comes after demonstrating significant long-term […]

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