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The device is meant to be used as an aid in identifying patients who have an adaptive immune response to the coronavirus in order to detect recent or prior infection. Read More
The point-of-care OCT imaging platform provides ultra-high-resolution image volumes of the margin of an excised tissue specimen, visualizing microscopic tissue structures 1 mm to 2 mm below their surface. Read More
The catheter uses a dynamic cage to separate clots from vessel walls while simultaneously drawing clots into itself, macerating them and transporting them out of the body. Read More
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
The test features a “pretreatment process” that inactivates the virus without compromising test quality or validity, helping to protect staff from infection. 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
When the device’s hemostat powder makes contact with blood or fluid in the gastrointestinal tract, a gelled matrix forms to provide a barrier that helps to further control bleeding, the company said. Read More