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CDRH has recognized low temperature vaporized hydrogen peroxide as an alternative to ethylene oxide (EtO) for medical device sterilization and is updating its reference documentation to assist manufacturers in making changes to sterilization procedures. Read More
The U.S. Justice Department (DOJ) has provided errant manufacturers with a way to avoid prosecution if they confess their misconduct right away. Read More
Coloplast has signed a $1.3 billion agreement to acquire Kerecis, a biologics wound care manufacturer based in Iceland, with an FDA-cleared patented technology platform based on intact fish skin. Read More
The FTC’s amicus brief in a product-bundling case has “broad implications for antitrust enforcement in the healthcare sector and beyond,” the FTC says, regarding its analysis of Medtronic’s motion to dismiss in a case that also involves exclusive-dealing. Read More
The FTC and the DOJ are pushing for rules that would require companies planning a merger or acquisition to forestall consummation until federal agencies have had enough time to more deeply investigate whether the transaction would violate antitrust laws and “harm the American public.” Read More
A dozen states have signed on to Illumina’s appeal of the Federal Trade Commission’s (FTC) order that the company divest itself of Grail — developer of the Galleri early cancer screening test — arguing that the commission’s process in the case was unconstitutional. Read More
Organizations should identify the potential impact of a hurricane on the supply chain, operations and facilities as well as consider stockpiling materials in the event of a disruption. Read More
Novo Nordisk and BIOCORP have entered into negotiations for Novo Nordisk to acquire a controlling stake in BIOCORP, a French company which has been developing a Bluetooth enabled smart add-on device for insulin pen injectors. Read More
Medical device manufacturers should prepare now for the potential disruption in fluctuating power, contaminants or unusual levels of heat or humidity that often occur during hurricane season, the FDA advises. Read More