Abbott Laboratories, of Abbott Park, Ill., said that the U.S. Centers for Medicare & Medicaid Services revised its national coverage determination to expand coverage for transcatheter edge-to-edge repair, also referred to as transcatheter mitral valve repair, to include patients with secondary (or functional) mitral regurgitation resulting from heart failure.
Aerobiotix, of Miamisburg, Ohio, reported a strategic partnership with the Association for Professionals in Infection Control and Epidemiology.
Align Technology Inc. has established its new global corporate headquarters in Tempe, Ariz., effective Jan. 1. The company’s San Jose, Calif., campus remains the hub for its global innovation, product and marketing organization and will become home to its new Digital Innovation Center, currently under construction.
Djo LLC, of Lewisville, Texas, reported the acquisition of Trilliant Surgical, a Houston-based provider of foot and ankle orthopedic implants. No financial details were disclosed.
Oslo, Norway-based Exact Therapeutics AS unveiled a collaboration with Chicago-based GE Healthcare to develop an ultrasound probe to be used in forthcoming studies using Acoustic Cluster Therapy across multiple disease conditions.
Singapore-based Genesis Medtech Group, which has reached a consensus to fully acquire China’s Hua Medtech as part of its plans to set up a specialized neurovascular franchise, entered a strategic cooperation with Penumbra Inc., of Alameda, Calif., for the domestic sales and production of products with Penumbra's technology for the Chinese market. Penumbra's products are used in more than 300 hospitals in China via distribution by Hua Medtech.
San Diego-based Histogen Inc. said the U.S. FDA has placed a clinical hold on its planned phase I/II clinical trial of Hst-003 for knee cartilage regeneration, pending answers to additional questions about the company IND submission. The company said it was notified verbally of the hold and expects to receive written notice by Feb. 12.
Inivata Inc., of Research Triangle Park, N.C., reported that the first patients have been tested using its Invisionfirst-Lung as part of the phase II ALKALINE trial sponsored by the European Organisation for Research and Treatment of Cancer. As part of the study, Invisionfirst-Lung liquid biopsy will be used to test and monitor ALK positive non-small-cell lung cancer patients beginning treatment with New York-based Pfizer Inc.’s third-generation ALK inhibitor therapy.
Princeton, N.J.-based Integra Lifesciences Holding Corp. said it has completed its acquisition of Acell Inc., of Columbia, Md.
Boston-based Labminds Inc. said its Revo automated solution preparation system has been approved for use in a GMP-certified laboratory in a top 10 pharmaceutical company.
Mercury Medical Inc., of Clearwater, Fla., said it has signed an agreement to become a certified U.S. distributor for East Syracuse, N.Y.-based Intersurgical Inc.’s Starmed Castar R hood in the acute care market.
Tel Aviv-based Mobileodt Ltd., a company focused on women’s health, said it has been awarded a $2.3 million Small Business Innovation and Research grant from the U.S. National Cancer Institute. The grant will be used to perform a large-scale clinical trial validating the efficacy of the company’s Eva Visual check artificial intelligence technology as a cervical screening clinical decision support tool at the point of care, providing results in less than 60 seconds. The Visualcheck AI technology will be compared to standard of care methods, such as Pap smear and visual inspection of the cervix.
Nexelis, a Laval, Quebec-based provider of advanced assay development and laboratory testing services in the infectious, oncologic and metabolic disease fields, is acquiring Brentford, U.K.-based Glaxosmithkline plc’s GCLP-certified clinical bioanalytical laboratory in Marburg, Germany. Terms of the deal were not disclosed.
Pressure Biosciences Inc. (PBI), of South Easton, Mass., is teaming up with Palo Alto, Calif.-based Sinusys Corp. to assess the feasibility of PBI’s Ultra Sheer Technology (UST) platform to improve the effectiveness of Sinusys’ lead product candidate Restora. If successful, Sinusys intends to license PBI’s UST platform for use in Restora on its path to U.S. FDA approval in a phase IIb trial later this year.
Preventiongenetics LLC, of Marshfield, Wis., said it has joined Nashville, Tenn.-based Concert Genetics Inc.’s preferred laboratory network, which brings health plans and preferred laboratories together to facilitate the exchange of quality, pricing and service information.
Toronto-based Relay Medical Corp. and Fio Corp., together Fionet Rapid Response Group, have launched their high-throughput COVID-19 mobile testing toolkit capable of processing 100 tests per hour.
San Clemente, Calif.-based Reshape Lifesciences Inc. has entered a definitive merger agreement with Obalon Therapeutics Inc., of Carlsbad, Calif., aimed at expanding its weight loss product offering. Financial details of the merger were not disclosed.
Solutions in Critical Care, of Allentown, Pa., said it was awarded a distribution contract with Irving, Texas-based Vizient Inc. for respiratory products. Effective March 1, Vizient members will have access to contracts for select respiratory care devices that offer increased savings.
Chicago-based Surgical Directions LLC has reached an agreement with Mednax Inc., of Sunrise, Fla., for a management buyout. Following the transaction, Surgical Directions will operate independently of Mednax. Terms of the transaction were not disclosed.
Wat Medical Enterprise Ltd., of Vancouver, British Columbia, said its wearable anti-obesity device, Obeend, has received U.S. Federal Communications Commission certification.