Author: FDAcop

Editas Medicine, a biotech firm specialized in CRISPR gene-editing technology, is planning to shift its focus towards developing in vivo therapies by partnering or out-licensing its ex vivo gene-editing treatment for rare blood diseases. This strategic pivot was announced as part of the company’s goal to concentrate on in vivo research and development which has […]

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At the INVEST 2025 event in Chicago, poised to occur from April 29-30, Kate Liebelt from Springboard Enterprises takes the spotlight to shed light on vital investment insights in healthcare. As a prelude to the main attraction — a pitch competition focusing on health tech, medtech, and biotech sectors — Liebelt provides a thorough review […]

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At the HLTH conference held in Las Vegas, FDA Commissioner Robert Califf engaged in a conversation with John Brownstein, Chief Innovation Officer at Boston Children’s Hospital. The discussion focused primarily on the burgeoning sector of healthcare AI and the FDA’s regulatory responsibilities. Califf highlighted the exponential growth within the field and acknowledged the necessity of […]

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Boston Scientific, a major player in the medical device industry, reported robust financial results in the third quarter, with net sales reaching $4.21 billion, marking a 19.4% year-over-year growth. The company’s sales were significantly driven by its cardiovascular segment which saw a 25% increase from the previous year, totaling $2.73 billion. Additionally, the MedSurg segment […]

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The Food and Drug Administration (FDA) recently approved prior design changes to iRhythm Technologies’ Zio AT, a wearable cardiac monitoring system. This approval was part of the first of two 510(k) submissions linked to the company’s efforts to address concerns raised by the FDA. In 2022, the FDA issued a warning letter to iRhythm for […]

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During the Medtech Conference hosted by Advamed last week, Michelle Tarver, the new director of the FDA’s device center, outlined the agency’s focus areas and future initiatives. The conference, held in Toronto, was a major gathering, attracting over 4,000 attendees including key stakeholders from the medical device sector and regulatory leaders from various countries. Michelle […]

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Boston Scientific recently achieved a significant milestone in medical technology for cardiac care by obtaining Food and Drug Administration (FDA) approval for its Farawave Nav treatment system. This breakthrough system is designed to address paroxysmal atrial fibrillation (AFib), a common and troublesome heart rhythm disorder that increases the risk of stroke. The Farawave Nav system […]

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Last week, the MedTech Conference in Toronto, the largest event organized by Advamed to date, attracted 4,350 participants from 48 countries. The conference featured discussions led by prominent industry leaders, including Michelle Tarver, the newly appointed acting director of the FDA’s device center, and other regulators from Canada, Europe, and Japan. Key topics included artificial […]

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The Food and Drug Administration (FDA) recently announced the appointment of Michelle Tarver as the permanent director of the agency’s Center for Devices and Radiological Health (CDRH), a decision first reported by Stat and confirmed by MedTech Dive. Tarver, who previously held the position of acting director following the resignation of Jeff Shuren in July, […]

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Recent discussions have highlighted the friction generated between healthcare systems and Medicare Advantage (MA) plans. Notably, many healthcare systems are choosing to sever their ties with certain MA plans, particularly those from Humana and UnitedHealthcare, while Humana also exits numerous markets. These steps reflect underlying tensions between payers and providers, sparking broad conceptions and underlining […]

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