March 25, 2022 If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier in March 2022 after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review. … Read more
March 22, 2022 The test works by detecting virulence factors released by the bacteria, which prompt a simple color change in a solution. The test could help clinicians to determine whether to prescribe antibiotics, and may help to avoid unnecessary prescribing. As the test can be administered at the point of care, and does not … Read more
March 18, 2022 The device may help prevent thrombosis and restenosis complications after surgery, particularly in patients with fragile skin. Although thrombosis can occur within 72 hours, and patients are supposed to be checked every hour for capillary fill and skin color, these assessments might only happen sporadically in the hospital and not at all … Read more
March 15, 2022 The FDA letter, dated October 22, stated that, after reviewing Apple’s 510(k) premarket notification of intent to market the device, the FDA determined that the device is substantially equivalent to legally marketed predicate devices for the indications Apple sought. Apple designed its “Irregular Rhythm Notification Feature 2.0” (IRNF 2.0) to include two … Read more
March 10, 2022 Supply chain snags and production issues are hampering schools’ ambitious plans to screen students and staff more widely for COVID as rapid test kits remain scarce in some places. In New Hampshire, where COVID cases are climbing and schools are grappling with outbreaks, elected officials are urging the Biden Administration to assist … Read more
March 08, 2022 Researchers at University College Cork (UCC) are leading an international team of scientists in developing Artificial Intelligence (AI) technology to detect brain injuries in newborns. To help minimize the risk of the life-long consequences of neonatal brain injury, researchers from the INFANT research center at UCC are leading the international team of … Read more
March 01, 2022 However, it has been much harder to get a sense of the real-world scale of the phenomenon. Is AI a perpetual technology of the future? Or is it starting to get a toehold? A recently released Food and Drug Administration (FDA) database starts to get at that question. The Agency combed records … Read more
February 25, 2022 United States researchers have successfully relieved a patient’s severe, long-term depression with an electronic implant that acts like a neural pacemaker, resetting the brain circuits associated with negative feelings. The team at the University of California, San Francisco (UCSF) said the study was “a landmark success” in the scientific effort to treat … Read more
February 23, 2022 Test makers including Abbott Laboratories, Quidel Corp and LumiraDX Ltd are scaling up production to meet rising demand. However, significantly boosting test output will take weeks to months, half a dozen industry executives told Reuters, making the tests harder to procure in the near term. “Employer demand has gone crazy,” said Quidel … Read more
February 17, 2022 The MedTech industry welcomed the broad goals of the proposed rule published late in 2018; however, pushed back hard against some of its provisions, notably with regard to FDA’s plans to carry out premarket manufacturing inspections. FDA, while making some tweaks to the draft, held firm on the main points of friction … Read more