The FDA has granted an emergency use authorization (EUA) for the home sample collection kit made by Austin, Texas-based Everlywell Inc., which can be run on two lab-developed tests. However, the agency has also shut down a Gates Foundation-backed effort in Seattle to develop another home sample collection kit even though the organization behind the effort has been authorized by state health authorities. The FDA announced the news about the Everlywell EUA with the stipulation that the user of the kit has completed an online questionnaire that is subsequently reviewed by a health care professional. Read More
Dry eye disease is a common problem, and Sight Sciences Inc., of Menlo Park, Calif., is looking to help those who suffer from the condition. Now, the company has seen the presentation of positive clinical data from the multicenter OLYMPIA study of Tearcare, which the company has heralded as the first wearable and intelligent eyelid technology for dry eye treatment. Read More
Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials. Read More
Balt USA LLC, of Irvine, Calif., has received a thumbs up from the FDA to begin an IDE trial of its Squid liquid embolic device for the treatment of chronic subdural hematoma (cSDH). The nonadhesive agent offers a minimally invasive option for a disabling neurological condition that often requires brain surgery to correct. Read More
BOGOTA – Mexican home appliances manufacturer Mabe Sa De Cv, from Mexico City, became a new member of the med-tech sector after taking the leap forward and joining the scores of companies around the world shifting their traditional manufacturing lines to develop med-tech products to fight COVID-19. Read More
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing. 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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Blue Earth Diagnostics, Sight Sciences, Teleflex. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Hospitals Group, Beckman Coulter, Behold.ai, Dascena, Illumina, Natera, Philips Healthcare US, Pulmonx, Qiagen, Renalytix AI, SyntheticMR, Thermo Fisher Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 1drop, Agilent, Edwards, Everlywell, Fulgent Genetics, Zebra Medical Vision. Read More
Keeping you up to date on recent developments in cardiology, including: Robotic PCI reduces radiation exposure; COVID-19 and cardiovascular problems; Heart attack prevention falls short for stroke, PAD patients; Integrated herpesvirus-6 is pre-eclampsia risk factor. Read More
