Westbury, N.Y.-based Bioivt, reported the opening of its new blood donor center on the Tufts University campus in Medford, Mass., to support academic and pharmaceutical researchers involved in COVID-19, cell and gene therapy research.
The Eurofins Scientific SE U.S. Clinical Diagnostics network said that blood-based antibody testing for coronavirus SARS-CoV-2 began April 6 at Boston Heart Diagnostics, a Framingham, Mass.-based Eurofins subsidiary.
Carmat SA, the Vélizy-Villacoublay, France-based designer and developer of a total artificial heart, reported that the French National Authority for Health has given its definitive approval to initiate a clinical study of the Carmat device within the framework of the Forfait Innovation program.
The University Centre for Research and Development at Chandigarh University, located in the Punjab state of India, said it has developed a solution with the help of 3D printing technology. A team of researchers headed by Ranvijay Kumar and students of mechatronics department have designed two-, three- and four-way ventilator splitters that aims to help in quadrupling the ventilator capacity of hospitals quickly.
Co-Diagnostics Inc., a Salt Lake City-based molecular diagnostics company, said that its Logix Smart Coronavirus COVID-19 test has obtained emergency use authorization from the U.S. FDA to be used for the diagnosis of SARS-CoV-2.
Deerfield Management Company LP, of New York, closed the Deerfield Healthcare Innovations Fund ll LP, which will invest in advancements in science that may lead to important therapeutic interventions and back new technologies and infrastructure to improve the way health care is delivered to patients. The $840 million health care venture fund will collaborate with more than 15 leading academic institutions to seed novel scientific research. The fund also has access to innovative med tech incubators created in partnership with two medical device industry leaders.
Itamar Medical Ltd., which has a presence in Caesarea, Israel, and Atlanta, has entered an agreement with San Diego-based Sleep Data Diagnostics and its virtual-care platform Betternight and Sleep Data Holdings, a provider of home-based positive airway pressure (PAP) services. The goal is to simplify the process by which physicians can refer patients for sleep apnea testing with Watchpat.
Luminex Corp., of Austin, Texas, said the U.S. FDA has issued an emergency use authorization for its Aries SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19. The system can run up to 144 tests per day, requiring no specialty training and minimal human interaction.
Mallinckrodt plc, of Staines-upon-Thames, U.K., said that Stratatech, a Mallinckrodt company, has initiated the rolling submission of a BLA to the U.S. FDA seeking approval to market Stratagraft, a regenerative skin tissue therapy, for the treatment of adult patients with deep partial-thickness thermal burns.
Salt Lake City-based Myriad Genetics Inc. received reimbursement and launched the BRACAnalysis Diagnostic System in Japan to help physicians determine which people have Hereditary Breast and Ovarian Cancer syndrome and qualify for additional diagnostic and medical management.
Nanomosaic LLC, of Cambridge, Mass., is teaming up with Massachusetts General Hospital to develop a new method for the prognostics and treatment of COVID-19 patients. Under the collaboration, clinicians at Mass General will assess the effect of FDA-approved treatments and methods on the effect of COVID-19 and may use Nanomosaic’s Tessera system to monitor and evaluate treatment.
Seattle-based Nanostring Technologies Inc. reported it is withdrawing its financial guidance for fiscal year 2020 due to market disruptions caused by the COVID-19 pandemic. Management may provide an updated outlook when first quarter operating results are announced, currently scheduled for May 7.
Miami-based Openmed Inc. has launched the Corona Checker app on iOS Apple Store and Openmed Checker on Google Play, an artificial intelligence-driven symptom evaluator coupled with coordinated definitive testing through a network of CLIA-certified lab and clinicians.
Opko Health Inc., of Miami, reported that its wholly owned subsidiary, Bioreference Laboratories Inc., based in Elmwood Park, N.J., will continue to prioritize COVID-19 testing for hospital patients and critically ill patients across the U.S.
Quotient Ltd., of Eysins, Switzerland, has completed development of a microarray-based SARS-CoV-1 antibody test for its high-throughput Mosaiq system. The company will provide the tests in Europe using a research use only label, while it pursues CE mark approval and FDA emergency use authorization.
Safeguard Scientifics Inc., of Radnor, Pa., reported several organizational changes to drive shareholder returns. Brian Sisko is stepping down as CEO, and Robert Rosenthal, currently chairman of the board, will assume the role of executive chairman. The company has named Eric Salzman to the newly created role of chief restructuring officer. Safeguard said that, due to the COVID-19 pandemic, the company expects to incur $5 to $12 million in non-cash impairment charges to its carrying values of several digital media and other interests during the quarter ended March 31, 2020. Follow-on funding requirements for the full year could exceed the prior estimate of $5 to $10 million, while corporate expenses are expected to be lower than the prior target of $6.4 to $6.8 million.
Carlsbad, Calif.-based Seaspine Holdings Corp. reported preliminary results for the first quarter of 2020, with revenue in the $35.8 million to $37.2 million range, down 1% from the same period last year. Seaspine withdrew its previous guidance for 2020, citing the uncertainty of the COVID-19 pandemic and its impact on elective surgeries. The company has imposed a hiring freeze and expects to delay or reduce some spending related to product development and product launches.
Santa Clara, Calif.-based Shockwave Medical Inc. said it has completed enrollment in the pivotal IDE DISRUPT CAD III study for the use of intravascular lithotripsy in heavily calcified coronary arteries. The Shockwave IVL system with Shockwave C2 coronary IVL catheter was granted FDA breakthrough status in September 2019.
Sono-Tek Corp., of Milton, N.Y., is producing ultrasonic coating systems that are being used in the fight against COVID-19, including coating systems that are currently in use by customers to make COVID-19 testing systems.
Mobile, Ala.-based Synergy Laboratories Inc. said it began offering coronavirus testing on April 1, making it the first medical laboratory in South Alabama to offer the tests.
Theranica Bioelectronics Ltd., of Netanya, Israel, reported that its drug-free migraine treatment device, Nerivio, is available on Scottsdale, Ariz.-based Upscript’s direct-to-patient telemedicine platform.