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Congestive heart failure device company BioVentrix is further expanding in its area of specialty by acquiring MateraCor for an undisclosed sum. Read More
New guidance from the European Union on implementing the In Vitro Diagnostics Regulation (IVDR) emphasizes that regulators will expect to see continuous evidence of a diagnostic product’s safety throughout its entire lifecycle. Read More
Chinese authorities have arrested AstraZeneca China employees who are accused of tampering with gene-testing results of tumor patients in order to fraudulently claim reimbursement from national health care insurance funds. Read More
The FDA’s proposed rule on over-the-counter (OTC) hearing aids has attracted more than a thousand public comments, some supportive of the proposal and some opposed to permitting marketing of hearing aids without a prescription. Read More
UK-based ConvaTec announced Friday that it plans to acquire Triad Life Sciences, a U.S. medical device company that develops biologically derived products to treat wounds and burns. Read More
The EU’s Clinical Trials Regulation (CTR) comes into effect today and harmonizes submissions, data assessment and supervision processes for trials across the EU and in the three European Economic Area (EEA) countries — Iceland, Liechtenstein and Norway. Read More