For much of the device industry, 2010 felt like a transition year, breeding uncertainty in a number of important areas, including the economy, health care reform, and impending changes to the 510(k) process. A review of the year just ended turns up these stories: Device M&A on the Rebound; Is A First-Mover Advantage Emerging In Medtech? Boston Scientific Is Back In The Game; Early-Stage Deals In Decline; The Future Of Medtech: Where Private Investment Dollars Are Flowing; Transcatheter Valves Take Center Stage; Spine's Downturn; Diabetes Assumptions Begin To Shift; A Landmark Year In Ophthalmology; Health Reform In 2010: A Beginning, Not An End; Changes At FDA: 510(k) Reform Takes Shape, and finally, Is Physician Choice In Product Selection In Danger?
By The EBI Medical Device Team
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Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
An interactive look at pharma, medtech and diagnostics deals made during March 2025. Data courtesy of Biomedtracker.
Alto Neuroscience’s CEO, Amit Etkin, believes the company’s biomarker-based approach to psychiatric treatment is the way forward.
The integration of digital health tools into clinical research and patient care is gaining momentum, and Merck KGaA, Darmstadt, Germany is not letting the grass grow under its feet. With an approach to digital biomarkers, the company is seeking to redefine how neurological diseases are monitored and managed.
