Irvine, Calif.-based startup Ocutrx Vision Technologies LLC unveiled new technology that it said helps surgeons better visualize the operative field during surgical procedures. The OR-Bot Surgery Visualization Theatre combines augmented reality (AR), virtual reality (VR) and both human- and robot-controlled arms to facilitate exacting medical procedures without the need for physicians to look away from the patient. Read More
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) has given the green light to Tokyo-based Fujirebio Inc.’s antigen test kit. Fumihito Takanashi, a spokesperson from the medical device evaluation division of the MHLW, told BioWorld that the approval came into effect May 14. Read More
“Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities,” Rick Bright, former director of the Biomedical Advanced Research and Development Authority, said today as he testified at a House subcommittee hearing on the U.S. response to COVID-19. Read More
The U.S. Patent and Trademark Office (PTO) has opened a priority track for patents related to the COVID-19 pandemic, another signal of federal government intent on overcoming this new plague. However, Scott Marty, a partner with the Atlanta office of Ballard Spahr LLP, told BioWorld that while the program offers some distinct advantages for pandemic-driven patents, inventors should have their filings in good form before entry because any delays incurred by a less-than-airtight application could lead the PTO to boot the application out of this program. Read More
Dermtech Inc., of La Jolla, Calif., has had a busy couple of weeks, revealing late last month that its noninvasive melanoma detection test is available for use via telemedicine. Now, the company has unveiled first-quarter results that saw assay revenue of $0.8 million, a 238% increase from the first quarter of 2019. Read More
LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test. The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June. 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: Cardiologs, Exact Sciences, Icad, Pluristem Therapeutics, Tiziana Life Sciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Archerdx, Bayer, Bluecross Blueshield of Tennessee, Caredx, Duality Technologies, Ekf Diagnostics, Integrated Computer Solutions, Lenovo, Lexent Bio, Progressive Care, Respiraworks, Senseonics, Transenterix, Tosoh Europe, Veracyte. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Medalliance. Read More
Keeping you up to date on recent developments in diagnostics, including: Accelerating de novo human genome assembly; DL model increases detection of pulmonary embolism; Carbohydrate metabolism implicated in neuropathy; T-cell mutations contribute to GVHD. Read More
