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Menlo Park Software Founder and CEO Rick Bollinger has begun an industry discovery campaign. He is interviewing manufacturing experts to explore their most pressing problems and how they deal with them. He says “medical device manufacture is a high-stakes industry”. It’s still using mainframe era software for product development and regulatory compliance. “what’s needed is 21st…
Original Source Stryker has snatched up Gauss Surgical after being drawn to its artificial intelligence-powered platform for monitoring a patient’s blood loss during surgery as well as following cesarean sections and childbirth. The company’s Triton system uses a computer vision app and an iPhone to visually measure a person’s loss of blood by capturing images of sponges,…
Original Source September 14th, 2021 [DETROIT, MI] – The Gilbert Family Foundation, a private nonprofit established by Jennifer and Dan Gilbert to accelerate a cure for neurofibromatosis type 1 (NF1), today announced funding of a new $5.4 million clinical study. The study, to be led by investigators at Children’s Hospital of Philadelphia and the Stanford University School…
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…
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…
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…
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…
Original Source CDC has released new data on the safety of the COVID-19 vaccines in pregnant people and is recommending all people 12 years of age and older get vaccinated against COVID-19. “CDC encourages all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated to protect themselves from COVID-19,” said…
CANTON, Mich. (August 12, 2021) – MMS Holdings Inc. (MMS) – an award-winning, data-focused CRO – announced today the launch of its pro-bono support program aimed at advancing research for ultra-rare diseases. Within this program, MMS will select from patient advocacy groups with demonstrable need and will provide complimentary regulatory assistance. This assistance program is…
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…
Original Source The Philippines became the world’s first country Friday to approve the commercial production of genetically modified “golden rice” that experts hope will combat childhood blindness and save lives in the developing world. A biosafety permit issued by government regulators paves the way for the rice — enriched with the vitamin A precursor beta-carotene…
Original Source KALAMAZOO, MI — A global supplier that has stayed true to its Kalamazoo roots, The Kalamazoo Spice Extraction Company (Kalsec), is expanding once again with the opening of a new facility in Kalamazoo. A leading producer of natural spice and herb extracts, colors, food protection and hop extracts for the food and beverage…
Original Source Funding will accelerate ongoing development of tissue and blood tests to broaden the reach and impact of precision medicine for patients with cancer ANN ARBOR, Mich., July 28, 2021 – Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced the completion of a $90 million Series C financing,…
CANTON, Mich. (July 28, 2021) – MMS Holdings (MMS) – an award-winning, data-focused CRO – announced that its learning arm, MMS Academy, has expanded its global training portfolio with the launch of new courses in inspection readiness and clinical programming. These new courses – created by industry-trained subject matter experts – will give students and…
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…