August 06, 2020 - Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the U.S., the company claims. The authorization gives healthcare professionals the ability to run a large number of patient tests for the … [Read more...]
Medtronic receives FDA approval for two new products: InterStim Micro Neurostimulator, InterStim SureScan MRI leads
August 03, 2020 - Medtronic plc (Dublin, Ireland) received approval from the U.S. Food and Drug Administration (FDA) for its InterStim Micro neurostimulator and InterStim SureScan MRI leads. InterStim Micro — the market’s smallest rechargeable device to deliver sacral neuromodulation (SNM) therapy — is used for treating overactive bladder (OAB), fecal incontinence (FI) and … [Read more...]
Pfizer, BioNTech to supply Japan with 120 million doses of MRNA-based COVID-19 vaccine candidate
July 31, 2020 – Pfizer (New York, NY) and BioNTech SE (Germany) announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of BNT162 mRNA-based vaccine candidate against SARS-CoV2 (the virus that causes COVID-19), subject to clinical success and regulatory approval, beginning in 2021. Financial details of the … [Read more...]
Thermo Fisher receives FDA approval for blood test for identifying novel allergic sensitization to red meat
July 23, 2020 - Thermo Fisher Scientific (Boston, MA) announced that the ImmunoCAP Specific IgE alpha-Gal Allergen Component test was cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use. The company says that the test results can aid specialists and other healthcare providers as they diagnose a patient's sensitization to the alpha-Gal … [Read more...]
Olympus launches new reloadable hemostasis clip for GI Endoscopy
July 23, 2020 - Olympus (Center Valley, PA) announced the commercial availability of its 510(k) cleared EZ Clip endotherapy device, a reloadable and rotatable hemostasis clip designed for bleed control and defect closure during GI endoscopy procedures in which more than one clip is needed. According to the company, the EZ Clip Applicator handle can be reloaded as needed to … [Read more...]
Abbott receives FDA approval for iOS-compatible app for people living with chronic pain
July 23, 2020 - Abbott (Abbott, IL) received approval from the U.S. Food and Drug Administration (FDA) for the use of the company's Patient Controller app on compatible personal Apple smartphone devices. At Abbott, this approval allows patients living with neurological conditions, including chronic pain or movement disorders, the ability to manage therapy directly from their … [Read more...]
Integra LifeSciences receives FDA clearance for specific neurosurgery indication for CUSA Clarity
July 22, 2020 – Integra LifeSciences Holdings Corporation (Princeton, NJ) received FDA clearance for a specific indication for neurosurgery for its CUSA Clarity Ultrasonic Surgical Aspirator System. Launched in 2017, the CUSA Clarity is the latest addition to the CUSA ultrasonic tissue ablation lineup. Although the CUSA system has been used for over 40 years in … [Read more...]
BD receives FDA approval for HPV test with extended genotyping capabilities
July 22, 2020 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity HPV Assay. The PMA supplement includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, … [Read more...]
Pfizer, BioNTech announce agreement with U.S. government for up to 600 million doses of COVID-19 vaccine candidate
July 22, 2020 – Pfizer Inc. (New York, NY) and BioNTech SE announced the execution of an agreement with the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) to meet the U.S. government’s “Operation Warp Speed” program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government … [Read more...]
Quidel’s Sofia SARS Antigen FIA updates EUA performance data to 96.7% PPA vs PCR
July 20, 2020 – Quidel Corporation (San Diego, CA) announced it has updated the performance data for its Sofia SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the U.S. Food and Drug Administration … [Read more...]