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The FDA said the device’s transvaginal approach reduces the number of incisions needed on the abdomen compared to conventional laparoscopic hysterectomy. Read More
More than 100 participants have achieved the trial’s primary endpoint, which is measuring the rate of overall clinical success at 24 months, Empirical Spine said. Read More
SUI is a condition often associated with childbirth and it is prevalent among women of all ages, including an estimated 20 million in the U.S. alone. Read More
“The Accula System complements our existing offerings and immediately provides our clinical customers with more options and flexibility for COVID-19 testing,” said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. Read More
The test features a “pretreatment process” that inactivates the virus without compromising test quality or validity, helping to protect staff from infection. Read More
Beginning Feb. 25, the way that software-based medical devices are regulated in Australia will change, and clinical decision support software that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods. Read More
The FDA’s Circulatory Devices Advisory Committee voted 14 to 3 in a Feb. 17 meeting that the benefits of Becton Dickinson’s Lutonix 014 drug-coated balloon don’t outweigh the risks for the proposed indications for use. Read More
Despite — or in part because of — COVID-19 challenges, the FDA’s Center for Devices and Radiological Health (CDRH) cleared a record 132 novel devices in 2020, surpassing its previous record of 106 in 2018. Read More
Priority Healthcare will pay Roche Diagnostics $43.3 million to settle a lawsuit alleging that it fraudulently submitted claims to insurers and pharmacy benefit managers for Roche’s Accu-Chek blood glucose test strips that put Roche on the hook for tens of millions of dollars. Read More