Medtech approvals: FDA releases September 2014 PMAs
November 19, 2014 by MassDevice
The U.S. Food & Drug Administration releases a list of pre-market approvals granted in September 2014. Read more
BrainScope wins FDA clearance for Ahead 100 brain-injury scanner
November 21, 2014 by Val Kennedy
BrainScope said it won 510(k) clearance from the FDA for its Ahead 100 device, designed to detect traumatic brain injury.
The Ahead 100 uses a patient’s EEG readings to help determine the structural condition of the brain. The handheld device is intended to help evaluate whether a patient should receive a CT scan, but should not be used in place of a scan, BrainScope said. Read more
FDA working to keep patients well informed
November 19, 2014 by MassDevice
My job in the Food and Drug Administration’s Office of Health and Constituent Affairs (OHCA) is to serve our nation’s patients in two ways: by listening to their concerns regarding FDA’s policy and decision-making and advocating for them in our agency; and by informing many patients and patient organizations about FDA’s mission and its work to advance the development, evaluation and approval of new therapeutic products.
This dialogue was formalized and greatly expanded in 2012 when, after a series of listening sessions with many patient advocacy organizations, OHCA created the Patient Network. Read more
FDA approves Avantis Third Eye Panoramic colonoscopy device
November 24, 2014 by Val Kennedy
Avantis Medical Systems said the FDA approved its Third Eye Panoramic digital imaging device for colonoscopies.
Avantis said the Third Eye device features 2 laterally positioned cameras that are able to produce a wide-angle image of more than 300°. The device is intended to help physicians to search for pre-cancerous polyps behind folds in the walls of the colon, according to a press release. Read more
FDA adds 'black box' warning to power morcellator labels
November 24, 2014 by Brad Perriello
The FDA today put so-called “black box” warnings on the labels for laparoscopic power morcellators advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.
The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids. Read more
