Dallas-based Aerus Medical LLC reported the start of a double-blind two-year clinical study to evaluate the impact its Aerus Medical Guardian with Activepure technology can have on reducing nosocomial infections, or health care-associated infections, also known as HAIs, from surgical operating room procedures. Aerus Medical Guardian with Activepure technology, a U.S. FDA Class II Medical Device, reduces bacteria and viruses in the air by 99.99% within 30 minutes and surface contamination by more than 99% after several hours. The primary goal of the randomized trial will be to determine whether filtering and sterilizing operating room air with the air purifier reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery. Secondarily, the trial will determine the effect of air filtration and sterilization on serious surgical site infections and on the cost of care. The trial is expected to begin in 2020 and last approximately two years. A minimum of 67,653 patients with a maximum of 86,639 patients will be needed for this study.
Avery Therapeutics Inc., a Tucson, Ariz.-based company dedicated to advancing tissue-engineered therapeutics to treat diseases and injuries to human muscle, and I Peace Inc., a Palo Alto, Calif.-based biotech startup developing, mass-manufacturing and commercializing technology of induced pluripotent stem cells (iPSCs), reported a service agreement to advance cell therapy for heart failure. I Peace will generate and supply GMP-grade iPSCs and related services to Avery Therapeutics, which will use them to derive cells used in the manufacturing of Mycardia. That product is in development for treatment of chronic heart failure.
New York-based Brain Scientific Inc. reported that its next generation disposable EEG cap, Neurocap, will now be available to the pediatric market across the U.S. The child-size Neurocap headset will assist clinicians in overcoming the common obstacles when conducting an electroencephalogram (EEG), including measuring and marking the patient’s head, and conducting required sanitation protocols afterwards.
Kansas City, Mo.-based Cerner Corp. reported an agreement to acquire Kantar Health, a division of London-based Kantar Group Ltd., for $375 million in cash, subject to adjustment. Kantar Health is a data, analytics and real-world evidence and commercial research consultancy serving the life science industry. With this acquisition, Cerner plans to harness data to improve the safety, efficiency and efficacy of clinical research across life sciences, pharmaceuticals and health care at large. This acquisition is expected to allow Cerner’s Learning Health Network SM client consortium to more directly engage with life sciences for funded research studies. The acquisition is anticipated to close in the first half of 2021 and is not expected to have a material impact on Cerner’s earnings in 2021.
Arcline Investment Management acquired a controlling stake in San Jose, Calif.-based Engineering by Design (EBD) from founders Dale and Judy Henson. EBD is the fifth acquisition in Arcline's medical-oriented manufacturing equipment platform, which also includes Glebar, Everite Machine Products, Syneo and Cath-Tip. EBD is a provider of interventional medical device and component manufacturing technologies, including precision coil winding equipment, catheter laminators and reflow machines, spooling and unspooling machines and custom solutions.
Farapulse Inc., of Menlo Park, Calif., said that the U.S. FDA conditionally approved the company's investigational device exemption application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its pulsed field ablation system for the treatment of paroxysmal atrial fibrillation.
Lexington, Mass.-based Fujifilm Medical Systems USA Inc., a provider of diagnostic imaging and medical informatics solutions, said that Uropartners, the largest urology practice in Illinois and top five in the nation, has chosen to standardize on the Persona CT (computed tomography) system to accelerate oncology treatment planning capabilities.
Jackson Center, Pa.-based Halberd Corp. said that it is pursuing development of its latest treatment variation in the fight against COVID-19. The procedure is designed to treat infected blood which has been dosed with a specific antibody compound and then exposed to tuned radio frequencies in an extracorporeal manner.
Hologic Inc., of Marlborough, Mass., said that 3D ultrasound imaging is now available on the Supersonic Mach 40 ultrasound system. Clinicians can now access high-resolution B-mode and Shearwave Plus elastography 3D volumes, which are designed to enhance diagnostic certainty.
Toronto-based Inagene Diagnostics has launched a new test for those looking to do more to protect themselves, and their families, in the event they are hospitalized for COVID-19, or other medical conditions. It is a simple cheek swab test that helps doctors predict how individuals will respond to commonly used drugs before they are administered.
Pasadena, Calif.-based Innova Medical Group Inc., which makes rapid antigen test kits, acquired Biological Laboratory Inc. (BIOLAB), with an eye toward further strengthening Innova’s in-house diagnostic testing and R&D capability in the U.S. BIOLAB will relocate to its new location in Pomona, Calif., in early 2021 and the expansion will add about 100 new jobs for the area. No financial details were disclosed.
International Rubber Products Group, of San Clemente, Calif., reported the acquisition of the assets of Pacoima, Calif.-based Kdl Precision Molding Corp., which focuses on critical-to-function molded components for the medical device, aerospace and defense, and oil rotary components industries. No financial details were disclosed.
Intrivo Diagnostics, a Los Angeles-based diagnostic testing provider, said that it will begin national distribution and commercialization of diagnostic testing products developed by Somerset, N.J.-based testing manufacturer Access Bio Inc. through Mckesson Medical-Surgical.
Stockholm-based Irras AB reported an exclusive distribution agreement with Belgrade, Serbia-based Medical Innovation Solutions, a distributor of world-class neurosurgical medical devices and technologies throughout Southeastern Europe, including the markets of Serbia, Croatia, Romania, North Macedonia, Slovenia and Hungary.
Knightscope Inc., of Mountain View, Calif., reported that it has added elevated body temperature detection to its growing list of features and capabilities.
Kubota Vision Inc., a Seattle-based clinical-stage specialty ophthalmology company and wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd., of Tokyo, today announced that the company achieved a milestone by completing a first spectacle-style wearable prototype based on Kubota Glasses technology.
New York-based Massive Bio Inc., which focuses on precision medicine and artificial intelligence-enabled patient-centric clinical trial enrollment, said it has been awarded a small business innovation research contract by the National Cancer Institute to develop and characterize the Deep Learning Clinical Trial Matching System.
Scottsdale, Ariz.-based Matrix Medical Network reported the completion of the integration of Biocerna LLC, a Fulton, Md.-based CLIA-certified and CAP-accredited laboratory dedicated to delivering clinical diagnostics tests to improve patients’ safety and quality of care throughout the U.S.
Personalis Inc., of Menlo Park, Calif., reported the launch of its Neoantigen Presentation Score, which combines analysis from its tumor neoantigen prediction tool, Systematic HLA Epitope Ranking Pan Algorithm, with mechanisms of immune evasion to better predict response to cancer therapy.
San Diego-based Progenity Inc. said it is expanding the availability of COVID-19 real-time polymerase chain reaction (RT-PCR) testing across the U.S. to support rising demand. Progenity is now offering “gold-standard” RT-PCR testing for COVID-19 through the CLIA-certified and CAP-accredited laboratory of its affiliate, Avero Diagnostics, of Irving, Texas, in all states except New York. Testing is performed using the TaqPath COVID-19 Combo Kit by Thermo Fisher Scientific Inc., of Waltham, Mass., under emergency use authorization by the U.S. FDA.
Quantumdx Group Ltd., of Newcastle Upon Tyne, U.K., said it is investing £11 million (US$14.96 million) to scale up to mass manufacture its Q-POC device and disposable test cassette, a point-of-care molecular diagnostic system that delivers results in about 30 minutes. The company’s first commercial assay for Q-POC will detect SARS-CoV-2, the virus causing COVID-19, and influenza A and B.
London-based Rldatix Ltd. reported a strategic relationship with Medstar Health’s National Center for Human Factors in Healthcare, part of the Medstar Health Research Institute, to enhance safety event reviews with human factors safety science. Under the arrangement The Medstar center will provide and deliver event review curriculum and consulting services based on human factors safety science as part of the Rldatix communication and Optimal Resolution (CANDOR) toolkit.
Amsterdam-based Royal Philips NV and Insightec Ltd., of Haifa, Israel, aim to expand access to magnetic resonance (MR)-guided focused ultrasound for incisionless neurosurgery by developing compatibility between Philips’ advanced MR systems and Insightec’s Exablate Neuro platform.
Transenterix Inc., of Research Triangle Park, N.C., reported that Slidell, La.-based Southern Surgical Hospital has entered into an agreement to lease and utilize its Senhance surgical system.
Viveve Medical Inc., of Englewood, Colo., said it received notice from The Nasdaq Stock Market LLC on Dec. 16, 2020, that it has regained compliance with the minimum bid price requirement. The company’s common stock will continue to be listed on the Nasdaq Capital Market.
Volpara Health Technologies Ltd., of Wellington, New Zealand, said US Radiology Specialists, of Raleigh, N.C., has selected the company’s Breast Health platform to drive quality breast imaging across its physician-owned network.