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Baxter has acquired medical technology company Hillrom in a $10.5 billion deal that will integrate Baxter’s medical and surgical devices with Hillrom’s digital healthcare products, which focus largely on hospital care. Read More
DeVilbiss Healthcare failed to report a complaint of an injury to a patient using its DeVilbiss 525DS oxygen concentrator to the FDA within the required 30 days, the agency said in a warning letter to the company. Read More
The FDA would gain new authority to compel device manufacturers to comply with record requests under a bipartisan bill introduced in the Senate Tuesday by Sens. Bill Cassidy (R-La.) and Tammy Baldwin (D-Wis.). Read More
The test can detect different genes from the SARS-CoV-2 virus that causes COVID-19 infection, making it more robust in detecting emerging viral variants, including Omicron. Read More
The Health Industry Distributors Association (HIDA) is calling for a “fast-pass” system to expedite movement of medical supplies, including personal protective equipment, through the U.S. transportation system. Read More
Device trade groups have urged the FDA to take its time in implementing a plan to reclassify certain imaging agents as devices rather than drugs. Read More