Despite seeing good growth in 2019, with net sales jumping to almost $2.4 million vs. $993,000 over the previous year, Electrocore Inc. has suspended its guidance due to uncertainty over COVID-19. The company previously said full-year revenue should be in the range of $7 million to $9 million. Read More
PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic. Read More
Trying to build out a new med-tech product category is a time-consuming and costly endeavor. Senseonics Holdings Inc. has long pursued the vision of extended-use, implantable continuous glucose monitoring. Since it was founded in 1996, the Germantown, Md.-based company has already spent roughly half a billion dollars to get there. Read More
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation. Read More
Aegea Medical Inc., of Menlo Park, Calif., has received U.S. FDA approval for its next-generation Mara water vapor ablation system, the only endometrial ablation treatment that uses vapor to treat heavy menstrual bleeding. The first commercial procedure was performed by Kirk Brody, an obstetrician-gynecologist in Chattanooga, Tenn. Read More
Everlywell Inc. stepped back from its announcement that consumers could access at-home testing for COVID-19 starting on March 23, 2020, following a U.S. FDA update that cautioned against fraudulent at-home tests. Read More
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval. Read More
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Affinity Health Partners, Allogene Therapeutics, Bellaseno, Curemetrix, Decipher Biosciences, Fiat Chrysler Automobiles, Ford Motor, GE Healthcare, Genmark Diagnostics, Global Center for Medical Innovation, Heat Biologics, Intervenn Biosciences, Iqvia, Letsgetchecked, Maxcyte, Nano-X Imaging, No Borders, Nuclein, Pathsensors, Protex, Q2 Solutions, Qiagen, Quest Diagnostics, Tamarin Health, Vero Biotech, Zoll. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aegea Medical, Biolase, Biofire Defence, Biomérieux, Diacarta, Helius Medical Technologies, Mesa Biotech. Read More
Keeping you up to date on recent developments in oncology, including: New study hints that 3D chromatin architecture a key in childhood leukemia; Recruiting NK cells to the antitumor battle; 3D printing meets the medical isotope business. Read More
