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Medtronic has completed its acquisition of Houston-based Visualase, agreeing to pay up to $105 million for the MRI-guided laser ablation system maker. Read More
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More
Members of Canadian medtech association MEDEC have approved a number of documents aimed at promoting ethical interactions between devicemakers and third-party distributors. Read More
More than 100 members of Congress are calling on the HHS Office of Inspector General to assess the effects and consequences of the competitive bidding program for durable medical equipment, prosthetics, orthotics and supplies in advance of plans to further expand the program. Read More
It’s back to bench testing for a specialty drug company after the FDA rejected its new drug application for a combination drug and device pain treatment product. Read More
Sponsors of companion diagnostics should submit applications to the FDA simultaneously with the drug product submission to improve the chances that the test on which the treatment relies is available when the drug is approved, an FDA final guidance says. Read More
Concerns about safety and efficacy data from a U.S. clinical trial, insufficient patient follow-up and the questionable culling of data from a European patient registry sank the Ablatherm-HIFU system for treatment of low-risk prostate cancer during a Wednesday FDA advisory panel meeting. Read More
For the first time, the FDA will begin regulating manufacturers of high to moderate risk laboratory-developed tests, a move that reverses the long-standing agency position that LDTs were not subject to FDA oversight. Read More