Dive Brief: Edwards Lifesciences is recalling a guide sheath used with its Pascal transcatheter mitral valve repair system sold in Europe because of possible damage to the device’s inner liner due to a manufacturing issue. While no adverse events or…
FDA clears Pentax duodenoscope with disposable part in bid to cut infection risk
Dive Brief: FDA cleared the first duodenoscope with a sterile, disposable elevator component Friday in an effort to cut down on the risk of infection from reprocessing the class of devices. The marketing authorization, granted to Pentax of America, follows…
FDA approves first contact lens indicated to slow the progression of nearsightedness in children
SILVER SPRING, Md., Nov. 15, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the…
Roche to Acquire Fibrosis-Focused Promedior for Up to $1.4 Billion
A year after Bristol-Myers Squibb walked away from acquiring Promedior and its fibrotic treatment portfolio, Swiss pharma giant Roche has stepped in to acquire the company and its pipeline for up to $1.4 billion. At the heart of the deal…
BeiGene Announces FDA Approval of Brukinsa for Mantle Cell Lymphoma
China’s BeiGene announced that the U.S. Food and Drug Administration (FDA) had given its Brukinsa (zanabrutinib) accelerated approval for mantle cell lymphoma (MCL) in adults who had received at least one prior therapy. It is the first BeiGene-discovered drug to…
FDA Approves Shionogi’s cUTI Medicine Following Positive Advisory Support
The U.S. Food and Drug Administration (FDA) approved Shionogi’s Fetroja as a treatment for adult patients with complicated urinary tract infections caused by a number of Gram-negative microorganisms. The approval came only a few days after the U.S. Centers for…
Weight-loss surgery for Type 2 diabetes could cut major heart risks, study suggests
Dive Brief: Metabolic, or bariatric, weight-loss surgeries ought to be taken seriously as a means to reduce incidence of major adverse cardiovascular events like heart failure, atrial fibrillation and heart attack, according to new research funded partly by Medtronic. The retrospective study…
Landmark Apple Watch AFib study has mixed results
Dive Brief: Final results from the landmark Apple Heart Study, which studied if a heart-rate pulse sensor can be used to identify atrial fibrillation, were published by Stanford University researchers in the New England Journal of Medicine on Wednesday. The…
FDA experts weigh evidence on patients’ adverse reactions to common device metals
With help from a wide-reaching FDA advisory committee meeting starting Wednesday, FDA is looking to expand its potential “toolbox” of methods to assess how a patient might respond to a metal implant. “Our goal is to have a full set…
TrialAssure Launches Document Anonymization Software
November 7, 2019 | TrialAssure today launched the limited release of ANONYMIZE R, a first-in-class document anonymization software that uses machine learning, natural language processing, and artificial intelligence to protect patient privacy by automatically finding and removing personal information from text.…
