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.
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.
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.
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.
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.
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.
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.
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.