Abbott Laboratories, of Abbott Park, Ill., said it has fulfilled the U.S. government’s order of 150 million Binaxnow COVID-19 Ag test and is now ready to support commercial distribution.
Vancouver, Wash.-based Absci LLC, a synthetic biology company enabling drug discovery and biomanufacturing of next-generation biotherapeutics, has acquired deep learning-focused Denovium Inc., of San Diego, for an undisclosed sum.
Artms Inc., of Vancouver, British Columbia, and Melbourne, Australia-based Teva Pharmaceuticals Ltd. have successfully produced Telix’s prostate cancer imaging product, TLX591-CDx (kit for the preparation of 68GA-PSMA-11), using multi-Curie quantities of cyclotron-produced Gallium-68 (68GA) via Artms’ proprietary Quantum Irradiation System solid target system.
Avista Capital Partners, a New York-based private equity firm with over $6 billion invested in more than 35 health care businesses globally, reported a strategic investment from Capital Constellation Management Inc., of New York.
Biolase Inc., of Foothill Ranch, Calif., reported an agreement with Dental Care Alliance Inc., of Sarasota, Fla., to expand laser adoption and hands-on training programs in targeted geographies across the U.S. The company expects the agreement to lead to a rollout across all DCA offices in 2021.
Blue Earth Diagnostics Ltd., of Oxford, U.K., reported the first patient dosed in its REVELATE study of 18F-fluciclovine, a positron emission tomography imaging radiopharmaceutical being studied for potential use in detecting recurrent brain metastases. REVELATE is a phase III, multicenter, single-arm imaging study being conducted in U.S. patients previously treated with radiation therapy.
Calgary, Alberta-based CardiAI Inc. said it has received provincial regulatory approval for a new, state-of-the-art laboratory to run various diagnostic tests, including the COVID-19 Covilamp-PCR and COVID-19 antibody tests.
Irvine, Calif.-based Cerenovus, a part of Johnson & Johnson Medical Device Companies, touted a new study demonstrating mechanical thrombectomy significantly reduces health care spending within the first year after ischemic stroke when complete or near complete reperfusion is achieved after the first pass, or attempt, compared with more than one pass. Patients achieving first pass effect (FPE) saw length of stay reduced from 9.48 days to 6.10 days. Per-patient cost savings during the acute care phase were $6,575 in the U.S. and €1,560 (US$1,833) in France. Additional cost savings are projected in the first year after stroke, varying from $4,116 in the U.S. to €823 in Italy. The study was published in the December issue of the Journal of Neurointerventional Surgery.
Endospan Ltd., of Herzliya, Israel, has enrolled the first patient in the TRIOMPHE study in Norfolk, Va. The multiarm, nonrandomized, prospective trial is evaluating the safety and effectiveness of the Nexus Aortic Arch Stent Graft system in treating thoracic aortic lesions involving the aortic arch. TRIOMPHE will enroll 100 patients at up to 30 sites.
Fidelis Sustainability Distribution LLC, of Carson City, Nev., in partnership with Toronto-based Synaptive Medical Inc., has been awarded a Medical Equipment ECAT contract by the Defense Logistics Agency valued at $45 million over five years. The ECAT contract is an online catalog of robotic-assisted surgery and other operating room-related products and acts as one of the preferred purchases sources for the U.S. Department of Defense and the Veterans Affairs health system. Fidelis works with Synaptive to provide ECAT customers with Synaptive’s Modus V robotic digital microscope.
Fineheart SA, of Bordeaux, France, said it has successfully completed a seven-day study of its Transcutaneous Energy Transfer system for recharging the Implantable Cardiac Output Monitoring System implantable battery.
Santa Monica, Calif.-based Gbt Technologies Inc. reported that Gbt Tokenize Corp. is seeking filing for its Qterm device with the U.S. FDA. The Qterm, a human vitals device powered by artificial intelligence, is aiming to measure human vitals with a touch of a finger.
Stockholm-based Irras AB, a company with a portfolio of products for neurocritical care, reported a collaboration agreement with Karolinska University Hospital that includes the initiation of an evaluation of Irraflow, the company's lead commercial product.
Itamar Medical Ltd., of Caesarea, Israel, has entered a definitive agreement to acquire the technology and assets of Spry Health for an undisclosed cash amount. Spry, based in the San Francisco Bay area, develops a wrist-based medical grade remote patient monitoring (RPM) solution.
Eindhoven, Netherlands-based Onward NV, formerly known as Gtx Medical, said the first patient has been enrolled in a pivotal trial evaluating the company’s Arc therapy. The pivotal trial, known as Up-LIFT, will evaluate the safety and effectiveness of Arc Therapy in restoring hand and arm function in people with spinal cord injury.
Hayward, Calif.-based Pulse Biosciences Inc. reported several developments related to the Cellfx system. The company noted that it had received notification from the U.S. FDA that its 510(k) submission for a general dermatology indication for the Cellfx system has advanced from substantive to interactive review. In addition, it has completed all treatments in its previously reported pivotal comparison study to evaluate the treatment of sebaceous hyperplasia (SH) using the Cellfx system, with the planned specific indication 510(k) submission as early as the end of the first quarter of the year. It also obtained investigational device exemption approval of a pivotal comparison study to evaluate the treatment of cutaneous non-genital warts using the Cellfx system, with enrollment expected to begin by the end of the first quarter.
Shimmer Research, which has a presence in Dublin, Cambridge, Mass., and Bangsar, Malaysia, said that Boston University School of Medicine has selected Shimmer’s Verisense wearable sensing platform to monitor participants’ motion, activity, and sleep in two brain health studies funded by the American Heart Association in collaboration with global philanthropist Bill Gates.
Smith+Nephew plc, of London, reported the successful introduction of its new field sales operations and inventory automation solution in the U.S. in partnership with San Diego-based Movemedical. The new platform is designed to deliver a more simplified and efficient way for field sales reps to manage their daily inventory operations.
Linden Capital Partners and Audax Private Equity, two middle-market private equity firms, have acquired Statlab Medical Products, of McKinney, Texas, Statlab is a manufacturer and distributor of consumables, reagents and equipment used by anatomic pathology, molecular diagnostics and other laboratories. Joe Bernardo, operating partner at Linden, has been appointed executive chairman of Statlab and will join the board. Michael Karsonovich, operating advisor at Linden, has been appointed CEO of Statlab and will also join the board.
Horsham, Pa.-based Strata Skin Sciences Inc. reported the introduction of a new business, branded “Home by XTRAC.” It provides an at-home, insurance-reimbursed treatment option for patients with certain skin diseases that do not qualify for in-office treatments and is anticipated to have a positive impact on revenue and profitability this year.
Treo Ventures, which was formerly known as Strategic Healthcare Investment Partners, a venture capital fund focused on investments in high impact companies at the intersection of biology and technology in medical devices and digital health, reported the successful closing of its $128 million debut fund. The fund has a presence in Silicon Valley and Dublin. Treo has been actively investing and building a portfolio of category defining companies including Hyalex Orthopedics, Cvrx, Shiratronics, Intuity Medical, Neochord, and Noctrix Health.
Orem, Utah-based Turner Imaging Systems, the developers of the Smart-C X-ray imaging system, has entered a sponsored research project with Massachusetts General Hospital to investigate the use of the Smart-C for weight-bearing radiographs of the foot and ankle.