Tag Archives: FDA

In an engaging episode of the Global Medical Device Podcast, host Etienne Nichols welcomed Dr. Asha Parekh, the CEO and co-founder of Frontline Medical Technologies. The discussion meticulously explored Dr. Parekh’s unconventional journey from a biomedical engineer to becoming an “accidental entrepreneur,” focusing on her critical role in developing innovative medical devices that significantly impact […]

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Senseonics, in partnership with Ascensia Diabetes Care, has received FDA clearance for an innovative medical device, the Eversense 365, an implantable glucose sensor designed for a wear time of one year. This clearance marks a significant advancement as it allows the sensor to be worn for double the duration of Senseonics’ previous model. The Eversense […]

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Implantable defibrillators are critical lifesaving devices used to correct abnormal heart rhythms by delivering a high-voltage shock, restoring the heart’s normal rhythm. However, defects in these devices can sometimes prevent them from functioning correctly, posing significant risks. In 2022, a significant event highlighted these risks when Medtronic issued a recall for over 85,000 defibrillator devices […]

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Connected health technology company Withings has achieved an exciting milestone by obtaining FDA 510(k) clearance for its innovative Sleep Rx Mat, a device specifically engineered to facilitate the home-based diagnosis of sleep apnea without direct contact with the body. The Sleep Rx Mat employs an advanced pneumatic sensor that meticulously tracks a wide range of […]

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As medical devices increasingly incorporate network connections, the significance of cybersecurity in the healthcare sector is escalating. These devices often store or transmit sensitive patient data, making them targets for cyber threats that could compromise data integrity and patient privacy. Consequently, regulatory bodies worldwide have been developing stringent standards to ensure the safety and security […]

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SS Innovations International is progressing towards securing pre-market authorization in the U.S. for its surgical robotic system, the SSi Mantra, by the end of 2025. This optimistic projection follows a pre-submission meeting with the Food and Drug Administration (FDA), as stated by the company in a recent announcement. Planning to use the FDA’s de novo […]

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Biologic drugs, traditionally administered via lengthy infusions, are now seeing revolutionary advancements with the FDA’s approval of injectable forms that drastically reduce treatment duration. Roche has successfully transformed two of its biologics into injectable versions, one targeting multiple sclerosis (MS) and the other, cancer, thus reducing patient dosing time from hours to minutes. The newly […]

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Inflammatix, a molecular diagnostics company based in Sunnyvale, California, has recently secured $57 million in funding. This financial boost aims to support the regulatory filing and early commercialization of its innovative rapid blood test for diagnosing acute infections and sepsis. The announcement, made on Thursday, increases the company’s total private capital to over $200 million, […]

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Amy Abernethy, a veteran healthcare leader with significant experience at institutions like the FDA and Verily, is championing the acceleration of clinical evidence generation to advance personalized treatment in the healthcare sector. In a recent interview, she emphasized the critical importance of clinical trials and real-world evidence in understanding effective treatments for patients, depending on […]

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If your company manufactures class II or III medical devices registered with the FDA, it’s crucial to prepare for routine FDA inspections. These inspections aim to ensure compliance with regulatory requirements, and regardless of your past inspection experiences, readiness plays a crucial role in determining how smoothly they proceed. Here are detailed actions and recommendations […]

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