Discovery of cancer ‘killer cod’ could inspire new treatments

February 26, 2019 The discovery, reported in the journals Nature Communications and eLife, is a code that is found in both large and small ribonucleic acids (RNAs).  The researchers also have early evidence that the small RNAs, called microRNAs, can be introduced into cells to trigger the kill switch.  “My goal was not to come … Read more

Two (2) studies use retinal scans to potentially identify earlier signs of Alzheimer’s disease

February 21, 2019 By using optical coherence tomography angiography, or OCT scans, researchers observed cross sections of patients’ retinas, visualizing the changes seen in its smallest blood vessels.  They believe that the deterioration of the retina may mirror the disease’s progression in the brain, conveyed across the optic nerve. The researchers were able to detect … Read more

Former FDA Commissioners Make the Case for an Independent Regulatory Agency

February 19, 2019 The session at a conference jointly hosted by the American University Washington College of Law and the Food and Drug Law Institute in October featured former FDA commissioners Robert Califf, Margaret Hamburg, David Kessler and Andrew von Eschenbach.  Lewis Grossman, Professor of Law at the American University, questioned the former commissioners on … Read more

Do male and female doctors prefer different communications? New study has some ideas.

February 15, 2019 Her interest was initially piqued by a Harvard study that found older patients who had female doctors had better outcomes than those with male doctors.  That got Dorfman thinking about what, if anything, that might mean for CMI/Compas clients who want to contact, converse with and educate physicians about their products.  The upshot:  Should pharma companies … Read more

3D human neural network could aid studies in brain diseases

February 12, 2019 Rather than using human neurons, the Tufts team used human-induced pluripotent stem cells (iPSCs) to build their models.  The resulting models carried the key structural and functional features of the brain and maintained neural activity for at least nine months, the team reported in the journal ACS Biometerials Science & Engineering. Because … Read more

New Apple Watch receives FDA clearance for built-in ECG

February 07, 2019 Much speculation has surrounded when and how the tech giant would jump into the healthcare waters — and it did so with a large splash, unveiling the new Series 4 model and its federal de novo clearance at Apple’s iPhone launch event in Cupertino, California.  Additionally, through new accelerometer and gyroscope hardware, … Read more

FDA planning to require cybersecurity checks in device submissions

February 06, 2019 The Health and Human Service (HHS) Inspector General’s Office recommended the FDA and manufacturers use pre-submission meetings to better address cybersecurity-related questions, and that the agency include cybersecurity as an element in its SMART template used in 510(k) submissions.  In addition, the Office urged the agency to begin requiring cybersecurity documentation elements … Read more