Tele: 561.316.3330

Breaking Medical Device Industry News

Friday, October 22, 2021




Rebus Biosystems Launches Automated Spatial Omics Platform

The new spatial omics platform will allow researchers to better understand the biology of tissues and lead to advancements in neuroscience, cancer, infectious disease and immunology.

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.

Perspectum Announces World’s 1st Integrated Imaging Service for Long Covid Is Approved by UK’s MHRA

Long COVID”, CoverScan MD quickly and safely provides medical professionals with the information critically needed to assess and evaluate patients.

Correlation of Campbell Score with Suicidal Ideation Clinical Trial Shows Positive Preliminary Data Advises Therapeutic Solutions International

The clinical trial is planned to recruit an additional 22 patients and aims to establish the validity of the Campbell Score™ as an objective marker to quantify the risk of suicide.

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.

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).

Eurofins Launches EmpowerDX SARS CoV 2 RT PCR Test Back on October 19, 2020

Eurofins has decided to donate part of its sequencing capacity to national public health authorities who do not have already approved funding to identify VUI2020-12/01 in their positive samples to evaluate local prevalence of this new strain.

By using this website you agree to accept Medical Device News Magazine Privacy Policy