Diagnostics & Healthcare News

Abbott and Edwards Lifesciences may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA Internal Medicine editor Dr. Rita Redberg, former FDA unique device identification (UDI) external program manager Madris Tomes and others examined a total of…

MedicaSafe, Inc. announced a partnership with Amneal Pharmaceuticals, Inc. to provide Amneal’s generic version of Suboxone® (buprenorphine and naloxone) as part of MedicaSafe’s data-generating medication system. This partnership provides a system aimed to deliver real-time information about the patient’s medication access pattern, producing actionable information for clinicians treating opioid use disorder (OUD). More than 2.5 million Americans…

A Baylor University researcher’s prototype smartphone app — designed to help parents detect early signs of various eye diseases in their children such as retinoblastoma, an aggressive pediatric eye cancer — has passed its first big test. The CRADLE app (ComputeR Assisted Detector LEukocoia) searches for traces of abnormal reflections from the retina called leukocoria…

Biodesix, Inc., announced it has been issued U.S. Patent Number 10,422,729, which covers the Biodesix Collection Device (BCD). The new device offers improved ease of use in blood sample collection for diagnostic testing, compared to current standard methods. “This device is intuitive and very easy to use,” remarked Susan Garwood, M.D., Pulmonary and Advanced Bronchoscopy…

A ground-breaking trial using 4G LTE cellular connectivity to enable beyond-visual-line-of-sight (BVLOS) drones to deliver automated external defibrillators (AEDs) to the scene of a cardiac arrest has taken place in the County of Renfrew, Ontario, Canada. Working in partnership with technology providers, including InDro Robotics, Cradlepoint and Ericsson, the trial demonstrated the drones’ capabilities to arrive more than seven…

The U.S. Food and Drug Administration today announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices. These are anticipated to be the first device types…

Current pathology techniques for analyzing biopsy tissues are lacking in their ability to detect cancer in small samples. Being able to rapidly study the distribution of protein expression within cells, gathered from minuscule samples, could be an important tool for early diagnosis and monitoring of cancer. Now, researchers at National University of Singapore have reported…

The FDA has updated its final guidance on its “refuse-to-accept” policy for 510(k) submissions. The guidance includes detailed checklists for devices that applicants want to be considered for traditional, abbreviated or special 510(k) clearance. The agency said it will respond to applications within 15 calendar days from submission and will notify applicants if information is missing. When…

A new type of ultrasound transducer from Fraunhofer should soon be delivering a fast and reliable diagnosis of infection of the middle ear. A U.S. company and the Fraunhofer Institute for Photonic Microsystems IPMS are collaborating on the development and application of this technology. The transducer is integrated in an otoscope and helps physicians decide…

Collaboration with Google on hearing aid specification now officially brings direct streaming of music, phone calls and other sound to people with hearing loss. For the first time, people can stream sound from their compatible Android devices to their hearing devices using Bluetooth Low Energy. GN Hearing, the global leader in hearing aid connectivity, and…