BioSpace News Archive

20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc., announced today that it is now accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits. These kits were the first to receive an emergency use authorization (EUA) from the FDA for point-of-care (POC) use with fingerstick blood samples on Sep

American Bio Medica Corporation announced they have signed a distribution agreement with Co-Diagnostics, Inc. granting ABMC the right to market and sell the Logix Smart Covid-19 tests in the United States on a non-exclusive basis.

Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Oct. 9, 2020 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the company’s New Drug Application (NDA) f

Littelfuse, Inc. (NASDAQ: LFUS), a global manufacturer of leading technologies in circuit protection, power control and sensing, announced today that it will release financial results for its third quarter of fiscal 2020 prior to market open on Wednesday, October 28, 2020.

In lieu of an in-person update to the media, Dr. Theresa Tam, Canada’s Chief Public Health Officer, issued the following statement today:

The Medical Device Innovation Consortium (MDIC) announced today that the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will participate in its Case for Quality Collaborative Community (CfQcc) initiative.

ERS Genomics Limited, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property (IP) co-owned by Professor Emmanuelle Charpentier, congratulates Emmanuelle on being awarded the 2020 Nobel Prize in Chemistry for her groundbreaking work on the CRISPR-Cas9 system.

Capillary Biomedical, Inc. (CapBio) has announced that it has received a $1.5 million program-related investment in the form of a loan from The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley). The use of funds includes clinical studies of CapBio’s

Micro-Tech Endoscopy recently launched the PinPoint Injection Needle, showcasing Micro-Tech’s continued commitment to make its mark on the medical device industry, working closely with doctors dedicated to innovation, and bringing high quality devices to market at unprecedented speed.

Lumenix is pleased to announce its advancement into artificial intelligence through the acquisition of the SIMPedsTM Artificially Intelligent Monitoring System (AIMS) prototype from Boston Children’s Hospital (BCH) completed in March 2020