The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019. Read More
The FDA’s weekly town hall on testing for the COVID-19 pandemic included the usual range of concerns about test performance, but concerns regarding swabs and sample sites continue to mount. The predicament has led to the announcement that the FDA along with the National Institutes of Health (NIH) will hold a May 15 town hall regarding swabs, with a particular interest in swabs produced via additive manufacturing. Read More
How is the COVID-19 pandemic affecting cancer treatment plans? Oncologists are weighing switching treatment plans, and they have many questions. That’s where Nanthealth Inc., of El Segundo, Calif., is looking to help. Read More
The U.S. does not have a universal health care system, which means that it fails to provide a consistent level of minimum care across its population. That means that basic and preventative care often falls through the cracks, even as the U.S. continues to excel at medical innovation and offer the most highly regarded health care in the world to those who can afford it. Read More
LONDON – The U.K. is launching a £28 million (US$34.5 million) project to sequence the whole genome of every COVID-19 patient in the country treated in intensive care, with the aim of uncovering host genetic factors that lead some people to be more severely affected by the infection. The study will involve up to 20,000 people currently or previously treated in one of 170 intensive care units (ICUs), whose genomes will be compared to 15,000 people with a confirmed infection who had mild or moderate symptoms. Read More
Ventilators are not designed to sit in storage for long periods of time unused. But that’s precisely what’s often required of this medical device, which then may require substantial repair and updates before it is functional. That’s a tale that’s been told repeatedly in this pandemic. Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Access Scientific, Apiject, Atrium Health, Butterfly Network, Canon Medical, Carmat, Centene, Change Healthcare, Dermalog, DNA Electronics, The DNA Company, Drӓgerwerk, Edap Tms, Exact Imaging, Liva Healthcare, My Next Health, My Pain Sensei, Nuvo Group, Polyganics, Rapid USA, REMsleep Holdings, Smiths Medical, Surfacide, Thermo Fisher Scientific, United Healthcare Services, Wuxi Diagnostics, Xleratehealth. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Critical Alert, Eko, Novocure, Optina Diagnostics, Zai Lab. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including the American Clinical Laboratory Association. Read More
Keeping you up to date on recent developments in orthopedics, including: UCLA scientists create first roadmap of human skeletal muscle development; Excess coffee consumption a culprit for poor health; Arthritis clinical trial shows support for dextrose injection to alleviate knee pain; Gene therapy in mice builds muscle, reduces fat. Read More
