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CooperCompanies is expanding its women’s health and fertility device portfolio in a $875 million purchase of Cook Medical’s reproductive health business. Read More
The FDA would be able to use outside evaluators to speed authorizations of in vitro diagnostic tests needed to identify the pathogens causing future pandemics if a bill pending in the Senate is enacted into law. Read More
Reduction of risk to patients and other end users is crucial to gaining market approval for new devices. Thus, risk reduction measures become inputs into device design, and implementation verification — an activity to prove the effectiveness of risk reduction measures — is applicable to design verification as well. Read More
A group of drug and device companies is asking the U.S. Court of Appeals for the D.C. Circuit to toss out its recent decision to revive a lawsuit in which plaintiffs are seeking to hold the companies liable for aiding in the funding of acts of terror in Iraq. Read More
The European Commission has again postponed a final decision on Illumina’s $8 billion acquisition of Grail — developer of the Galleri blood test, which can detect 50 different cancers before patients are symptomatic. Read More
The FDA has issued final orders classifying four medical devices as Class II (special controls), and said the classification will help increase patient access to the devices. Read More
In an effort to better understand high prices for drugs and diagnostics, prominent doctors groups and other advocacy groups have called on the Biden administration to openly share the costs of clinical trials paid for by the federal government. Read More
The FDA needs to work with the Federal Trade Commission (FTC) and other federal agencies to improve its regulation of at-home diagnostics, which are not clearly distinguished from relatively unregulated “general wellness products,” according to an opinion piece by three bioethicists in the Journal of the American Medical Association. Read More