Delphinus Receives FDA Approval for its SoftVue 3D Whole Breast Ultrasound Tomography System

The SoftVue™ 3D Whole Breast Ultrasound Tomography System from Delphinus Medical Technologies, Inc. is indicated for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. Clinical evidence has demonstrated that SoftVue enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially…

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FDA authorizes Pfizer Covid-19 vaccine for children aged 5 to 11

Original Source The Food and Drug Administration granted emergency use authorization to the Covid-19 vaccine developed by Pfizer and its partner BioNTech Friday for children ages 5 to 11, a significant step toward making the vaccine available to millions of school-age children. Before the vaccine becomes widely available, it will also need to be recommended…

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Health care plagued by new supply chain shortages

Original Source From medications to gloves to crutches, the strains of the global supply chain are hitting U.S. health care hard. Why it matters: Shortages of health care supplies can quickly jump from a nuisance to a life-or-death proposition. They indicate serious vulnerabilities in the U.S. health care supply chain. State of play: After seeing major supply…

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Neogen acquires pet medications maker CAPInnoVet

Original Source LANSING — Food and animal safety products maker Neogen Corp. has bolstered its holding in the fast-growing veterinary market with the acquisition of an Atlanta-based companion animal health company. On Monday, Lansing-based Neogen (Nasdaq: NEOG) said it acquired CAPInnoVet Inc., a provider of pet medications that offer protection from fleas, ticks and mosquitoes at what…

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Phenomics Health Validates Patented Technology Following Seed Financing Personalized Medicine for Medication Selection and Monitoring

Plymouth, MI – September 22, 2021 – Phenomics Health Inc., a platform bioinformatics-based precision medicine company, today announced completion of clinical product development and validation for its PrecīsMed™ pharmacometabolomics (PMx) technology in its new CLIA laboratory located at the Michigan Life Science and Innovation Center. The company’s laboratory operations, validation, as well as ongoing research…

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Cayman Receives Grant to Evaluate Use of KMN-159 to Accelerate Dental Implant Osseointegration

ANN ARBOR, MI, September 16, 2021 — The National Institute of Dental and Craniofacial Research has awarded Cayman Chemical with a $1,700,500 grant to explore Cayman’s patented small molecule bone repair agent KMN-159 as the active pharmaceutical ingredient (API) in a drug-device combination to improve the mechanical anchorage of dental titanium implants into the jawbone. The…

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FDA Approves First COVID-19 Vaccine

Original Source Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency…

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FDA Targets Early September for Approving Pfizer’s Covid-19 Vaccine

Original Source The Food and Drug Administration is expected to approve Pfizer’s coronavirus vaccine by early September, amid a resurgence of cases that has heightened pressure on the administration to get more Americans vaccinated. While the agency had long eyed the fall for granting full licensure, officials have recently accelerated their work, and now hope…

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WHO Issues New Recommendations on Human Genome Editing for the Advancement of Public Health

Original Source Two new companion reports released today by the World Health Organization (WHO) provide the first global recommendations to help establish human genome editing as a tool for public health, with an emphasis on safety, effectiveness and ethics. The forward-looking new reports result from the first broad, global consultation looking at somatic, germline and heritable human…

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Sickle Cell Disease and a Pivotal Moment to End Health Inequality

Original Source Covid-19 laid bare the long-standing vulnerability of minority and low-income communities in U.S. society and its health system even as we celebrated the power of scientific innovation to rein in the pandemic. It’s time to turn that innovation, driven by an even greater mind shift, to end inequality in treatment. In perhaps no…

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