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OrthoGroup was handed a Form 483 after an inspection of its Rancho Cordova, Calif., facility found incomplete device history records (DHR), missing corrective and preventive action (CAPA) records and multiple procedures not being followed. Read More
Merck KGaA has partnered with French devicemaker Biocorp to create a new version of Biocorp’s Mallya pen injector smart device for delivery of human growth hormone. Read More
Prostate cancer patients treated with Accuray’s CyberKnife robotic radiotherapy needed fewer sessions compared to patients treated with conventional radiotherapy, researchers reported in the journal The Lancet Oncology. Read More
The FDA has announced the launch of a pilot program to give faster and more widespread access to medical devices of public health importance and strengthen the agency’s Breakthrough Devices program. Read More