The FDA guidance does give potential 3D medical device manufacturers a path to follow to prepare for FDA approval.
New research shows that wearables and remote patient monitoring technology have a limited impact on clinical outcomes. But digital health researchers aren't ready to abandon the promise of mobile technology.
Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
Women who started menstruating at the age of 11 or younger, or entered menopause before 47, face a higher risk of heart disease and stroke, according to a study published Tuesday. Miscarriage, stillbirth, undergoing a hysterectomy, and bearing children at a young age were also associated with elevated odds of cardiovascular problems later in life, researchers found.
Natural Cycles, a contraceptive app that became certified in the EU as a form of birth control, has been hit with a complaint after being blamed for causing 37 unwanted pregnancies
NHS officials have surmised that a system that identifies seriously ill patients would save approximately 2,000 lives a year. They have also estimated that 627,000 ‘bed days’ could be saved as a result.
Mount Sinai researchers have discovered that normal immune cells called macrophages, which reside in healthy breast tissue surrounding milk ducts, play a major role in helping early breast cancer cells leave the breast for other parts of the body, potentially creating metastasis before a tumor has even developed, according to a study published in Nature Communications.
Women attempting pregnancy may experience difficulty or delays in conceiving when they have moderate or severe iodine deficiency, according to findings published in Human Reproduction.
According to the Frost & Sullivan study, the total revenue of the global cloud-based medical imaging informatics market is expected to remain on a very strong growth trajectory over the next few years, growing from $285.4 million in 2016 to $830.5 million in 2021. That's a significant compound annual growth rate of 23.8 percent.
Stem cells have the unique capability to transform into any sort of specialized cell needed in the body, making them especially promising for medicine that replaces nonfunctional or dead cells.
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