The FDA has approved an investigational device exemption (IDE) clinical trial to investigate a left ventricular assist device (LVAD) system small enough for use in infants and children. The Jarvik 15mm device, introduced earlier this year by Jarvik Heart, is adjustable for long-term use in children as they grow and wait for a suitable heart transplant.
GE Healthcare continues to grow in its third quarter of 2016, and the company posted double-digit profit growth for its healthcare business despite substantial challenges in other segments, principally oil and gas. Senior executives attribute 8 percent growth in overall healthcare orders to strength in imaging and continued momentum in the Chinese market.
Optical fibers designed using biocompatible hydrogel could play a role in next-generation, flexible biosensors, according to scientists at Harvard University and MIT. By tracking the quality of light shining through the stretchy fibers, researchers could use the technology in implantable or wearable devices to monitor muscle mobility, tumor growth, or inflammation over time.
According to researchers, the citrus-based polymer material used has natural antioxidant properties, and could potentially be loaded with anti-coagulation drugs to minimize complications.
An investigative report by the Star Tribune revealed that FDA accepted “retrospective summary reports” that cover hundreds of thousands of incidents, years after they occurred. FDA argued that excessive paperwork would “clog” the reporting system and be of little use to the public.
Abbott and St. Jude Medical have agreed to sell a portion of their vascular closure and electrophysiology businesses to Terumo for approximately $1.12 billion, contingent on Abbott’s successful purchase of St. Jude.
The U.K.’s National Health Service (NHS) and National Institute for Health and Care Excellence (NICE) have, in joint consultation, released a list of proposals aimed at improving patient access to cost-effective medical technologies.
The FDA has released guidance that clarifies its suggested approach to the clinical evaluation of software as a medical device (SaMD). The guidance was developed by the International Medical Device Regulators Forum (IMDRF) and is meant to establish “globally harmonized principles” of what evaluation of software is appropriate, based on its potential risk
A new medical imaging modality developed by scientists at the University of Virginia (UVA) combines magnetic resonance imaging (MRI) with gamma-ray imaging using xenon isotopes.
Abbott has entered into strategic collaborations with two pharmaceutical companies — Celgene and Agios — to develop diagnostic tests on Abbott’s m2000 RealTime system that identify certain genomic mutations associated with acute myeloid leukemia (AML). Both Celgene and Agios are currently developing experimental drugs that may halt the progression of AML by targeting these mutations.