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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
Ambra Health drew a Form 483 for failing to report a recall to the FDA and properly investigate customer complaints, among other lapses observed during an inspection of its New York City facility. Read More
Medtronic’s extravascular (EV) implantable cardioverter–defibrillator (ICD) had a 98.7 percent successful defibrillation rate after implantation in a recent study, researchers reported in the New England Journal of Medicine. Read More
An effective strategy to maintain compliance with the EU Medical Device Regulation (MDR) requires systems to monitor key factors and take appropriate actions in the face of changing regulatory instruments. Read More
The FDA has extended the comment period for its draft guidance on LASIK devices by 30 days in response to multiple requests by device groups. Read More
General Physiotherapy was hit with a Form 483 after an FDA investigator observed product testing and other quality deficiencies at the company’s Earth City, Mo., facility. Read More