Category:
BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.
StemVacs Cellular Immunotherapy: Positive Animal Data Reported in the 4T1 Breast Cancer Model
"The current data, which conclusively demonstrates the induction of immunological memory to cancer, as well as the natural killer cell as a mechanism of action, will position us to provide the FDA responses to their questions from our submitted IND," said Dr. James Veltmeyer, Chief Medical Officer of the Company.
Bioclinica Announces Breakthrough AI Image Redaction Technology for Clinical Trials
New solution offers pharmaceutical and biotech companies a powerful tool for video, photo, and PDF redaction, ensuring compliance and patient privacy.
Manufacturer of Human Induced Pluripotent Stem Cells Achieves Milestone GMP Certification to Manufacture Cord Blood-derived iPSCs
GMP certification and Manufacturing Authorization pave the way for the company to deliver fully characterized clinical-grade iPSCs that are derived from human cord blood cells for the development of cell-based therapies.
Helix Platform Granted the 1st and Only FDA Authorization for a Whole Exome Sequencing Platform
Helix advises this marks the first time such a broad, sequencing-based device has been authorized by the FDA.
Budapest-based ZTA Biotech Develops ELISA Protocol for COVID-19 IgG Antibody Detection
This new detection method represents a great step forward in determining if patients have had COVID-19 and if they might still have immunity to the disease.
CareVax Vaccine Tracking Program Launches
CareVax is being released in the US first, internationally in early Q1, and is poised to work with government public health agencies at the federal, state, local county, and city levels offering a data-driven solution that can provide real-time analytic, surveillance and market intelligence in order to make more informed care decisions.
Mologic Receives CE Mark Approval for Professional-Use COVID-19 Rapid Antigen Test
The company notes the test will provide health professionals with accurate detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs, within 10 minutes.
OraSure Technologies Reports OMNIgene®·ORAL Device Now Included in EUA Amendment Granted to 3B BlackBio Biotech India for SARS-CoV-2 Test
The company advises this EUA amendment will allow 3B BlackBio Biotech’s North American distributor, Genophyll Enterprises, to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S. as well as from their upcoming New Jersey-based laboratory.
Briotech Expands: Company Moves to a 82,000 SF Class-A Wesmar Building in Woodinville, Washington
Briotech notes that in addition to its flagship product, Briotech Topical Skin Spray, Briotech produces Super Oxidized Saline for oral use, and an EPA approved Multi Surface Sanitizer + Disinfectant effective against coronavirus (the novel SARS-CoV-2 pandemic virus that causes COVID-19).
