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BioWorld - Friday, May 16, 2025
Breaking News: US FDA clears Abbvie’s c-Met lung cancer ADC Breaking News: 100 days of uncertaintyBreaking News: 100 days of uncertainty
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BioWorld MedTech, Clinical
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Abbott's Tendyne scores well in trial of patients with severe calcification

Sep. 11, 2019
By Mark McCarty
The recent progress in interventional cardiology has largely been driven by the aortic valve, although calcification of the aortic root has proven a difficult hurdle to overcome. A newly published study demonstrates that the Tendyne device by Abbott Vascular Inc., of Santa Clara, Calif., can be readily used not just to treat failing mitral valves, but works well in these patients with severe calcification, an achievement that could quickly vault the transcatheter approach past conventional surgical approaches in this population.
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Product clinical data for Sept. 6, 2019

Sep. 9, 2019

Abbott launches IDE trial of leaky tricuspid heart valve technique

Sep. 6, 2019
By Meg Bryant
Abbott Laboratories has kicked off a pivotal study to evaluate its catheter-based Triclip transcatheter tricuspid valve repair system in patients with severe tricuspid regurgitation (TR). The first enrollments in the U.S. FDA-approved Triluminate study were performed at Abbott Northwestern Hospital in Minneapolis by a cardiac team led by Paul Sorajja, director of the Center for Valve and Structural Heart Disease at the Minneapolis Heart Institute and co-primary investigator for the trial.
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No Pfizer common divisor in DMD; tox woe bestows 'Solid' favor on Sarepta

July 29, 2019
By Randy Osborne
In late June, when Pfizer Inc. unveiled the first phase Ib data, mixed safety signal and all, for its Duchenne muscular dystrophy (DMD) gene therapy, PF-06939926, investors in Sarepta Therapeutics Inc. as well as Solid Biosciences Inc. watched with particular interest. The latter firm seems none the worse for wear, though, raising $60 million in a private placement.
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Study finds startup Paige's cancer pathology algorithms have clinical-grade accuracy

July 23, 2019
By Stacy Lawrence
Deep learning algorithms developed at the Memorial Sloan Kettering Cancer Center (MSK) were able to distinguish prostate, skin and breast cancer with nearly perfect accuracy in a recent clinical trial. The technology has already been licensed exclusively by New York-based startup Paige.AI, which snapped up a $25 million series A early last year to continue to advance it.
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Beta Bionics completes first home-use trial of its bihormonal bionic pancreas in T1 diabetes

June 11, 2019
By Stacy Lawrence
Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients.
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Apple Heart study seen as first salvo in digital war on AF

March 19, 2019
By Mark McCarty
NEW ORLEANS – The Apple Heart study has accumulated data from more than 400,000 participants in its evaluation of the ability of an algorithm to detect abnormalities that may be indicative of atrial fibrillation (AF), although the enrollment came up short of the target of half a million users. Nonetheless, Mintu Turakhia, a cardiologist at Stanford, Calif.-based Stanford University, said that while the study has some significant limitations, "we now have a footprint for evaluating technology such as this, and how to do this in an appropriate and scalable way."
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