Month: September 2024

Establishment Labs has recently received premarket approval from the Food and Drug Administration (FDA) for its Motiva breast implants. This notable event marks the first new breast implant approved in the U.S. since 2013, introducing a significant shift in a market landscape previously altered by safety concerns, notably leading to the withdrawal of Allergan’s Biocell […]

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The innovative drug Dupixent, developed by Sanofi and Regeneron Pharmaceuticals, has already made a significant impact in the treatment of various skin and lung disorders. Recently, it has received FDA approval for a new indication—chronic obstructive pulmonary disease (COPD), a lung condition generally associated with smoking but also found in non-smokers. This approval marks a […]

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When Tesla launched its electric cars in 2012, it quickly established hundreds of charging stations nationwide, expanding to thousands globally and selling nearly 5 million vehicles since. Contrastingly, Electronic Health Records (EHRs), introduced in 1962, took over six decades to show significant benefits due to slow adoption in healthcare systems. This difference in deployment of […]

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An interdisciplinary team of Chinese researchers has made significant advancements in the field of continuous glucose monitoring (CGM) systems by developing a miniaturized device that potentially matches the performance of leading market alternatives. This new CGM sensor, designed utilizing an organic electrochemical transistor (OECT), offers improved amplification of the signal-to-noise ratio compared to traditional sensors, […]

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Mendaera, a Silicon Valley-based firm, recently raised $73 million to further develop a handheld robotics platform designed for a range of medical procedures including biopsies, organ and vascular access, and pain management. This funding initiative marks a substantial push towards revolutionizing commonly practiced medical procedures through advanced robotics. The company was co-founded by Josh DeFonzo […]

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Schizophrenia, affecting approximately 2.8 million people in the U.S., has traditionally been managed with medications that often come with severe side effects and limited effectiveness, resulting in poor adherence by patients. Recognizing the need for improved treatments, the Food and Drug Administration (FDA) recently approved Bristol Myers Squibb’s (BMS) new drug, Cobenfy. This approval marks […]

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Healthcare providers are increasingly incorporating AI technologies, with many reporting a boost in their technology spending over the last year. This surge in adoption reflects the enthusiasm and potential seen in AI’s ability to transform various aspects of healthcare. Dr. Arash Harzand, a respected figure in cardiology from Emory University and the chief health officer […]

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Qure.ai, a Mumbai-based company, recently raised $65 million in a Series D funding round led by Lightspeed and 360 ONE Asset. The funds will primarily be used to invest in foundational AI models and acquire complementary startups in the medical technology sector. Additionally, Qure.ai plans to use the financial boost to expand its operations in […]

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The FDA is proposing a significant modification in the classification of hepatitis B virus (HBV) tests, shifting them from a high-risk category (class III) to a moderate-risk category (class II). This change, detailed in a recent notice, would allow these devices to access the 510(k) pathway rather than undergoing the more stringent premarket approval requirements […]

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Two House Democrats, Representatives Anna Eshoo of California and Rosa DeLauro of Connecticut, have called for an official investigation into Jeff Shuren, the former director of the FDA’s Center for Devices and Radiological Health. This request follows a report by The New York Times detailing potential conflicts of interest during Shuren’s tenure. The representatives expressed […]

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