Stockholm-based Bactiguard AB completed its acquisition of Vigilenz Medical Devices Sdn. Bhd., of Penang, Malaysia, and Vigilenz Medical Supplies Sdn. Bhd., of Selangor, Malaysia. The transaction consists of a $4.5 million cash payment, which has been paid, plus 241,512 new class B shares in Bactiguard, which must be approved at Bactiguard’s April 28, 2020, annual meeting. Integration of the companies has begun, and the newly acquired companies’ financials will be consolidated into Bactiguard’s beginning March 1.
Co-Diagnostics Inc., of Salt Lake City, said its COVID-19 test kits are available at CLIA-certified laboratories in the U.S., following an FDA policy change that allows CLIA labs to use COVID-19 tests before the agency completes its review of labs’ submissions for emergency use authorization.
Deeside, U.K.-based Convatec plc is ramping up its Asia Pacific focus with a fully integrated business unit called Global Emerging Markets. Headquartered in Singapore, GEM will also build market capabilities in Latin America, the Middle East and Africa.
Implandata Ophthalmic Products GmbH, of Hannover, Germany, has completed enrollment in its international ARGOS-SCO1 trial, a first-in-human study to validate the suprachoroidally placed Eyemate-SC sensor implant for continual monitoring of intraocular pressure. While the company’s CE-marked Eyemate-IO intraocular lens sensor implant is indicated for glaucoma patients undergoing cataract surgery, the Eyemate-SC is intended for glaucoma patients not yet recommended for cataract surgery.
Insulet Corp., of Acton, Mass., plans to pause its pivotal study of the Omnipod Horizon automated glucose control system due to a software problem. The issue could cause the system to use an incorrect glucose value, which could impact insulin delivery. No adverse effects have been reported, the company said, adding the updated software will be available by the end of April. The pause is expected to push the commercial launch of Horizon to early 2021. BTIG analysts gave the company a neutral rating, saying the decision to pause the study is “the right approach and essential for safety,” but likely to pressure shares in the near term.
Fort Myers, Fla.-based Neogenomics Inc. has been awarded a three-year contract to be the primary laboratory for Health Trust Purchasing Group L.P.’s specialized reference laboratory for oncology and cancer genetics, a newly created category for cancer diagnostics in personalized medicine. The agreement, which takes effect March 1, 2020, provides standardized corporate pricing for all HPG-affiliated facilities and providers in the U.S.
New York-based Pavmed Inc. said its majority-owned subsidiary, Lucid Diagnostics Inc., entered an agreement with the University of Pennsylvania for a clinical trial designed to evaluate whether Lucid’s Esocheck esophageal cell collection device with Collect+Protect Technology provides a less invasive, more efficient, and cost-effective alternative to endoscopic biopsies in the management of patients with eosinophilic esophagitis.
Melbourn, U.K.-based The Technology Partnership plc and Diasorin S.p.A., of Saluggia, Italy, have signed an exclusive license and technology transfer agreement. Diasorin will combine its molecular test offering with TTP’s Puckdx platform to develop a single-use, sample-to-answer, molecular diagnostics point-of-care platform for human in vitro diagnostic applications.
Vivalnk, a Campbell, Calif.-based provider of connected health care solutions that also has a presence in Hangzhou, China, reported a multipatient remote monitoring solution with Alibaba (China) Co. Ltd., also of Hangzhou. The solution is designed for caregivers to safely and efficiently monitor large numbers of patients while minimizing physical contact. Initially targeting patient temperature, the remote monitoring solution can be extended to track other vitals and biometrics. At present, the solution has been deployed in 14 hospitals. Although the solution was prompted by the COVID-19 coronavirus, it can be suitable for monitoring patients with other types of infectious diseases.