Advanced Development of Additive Manufacturing, a 3D-bioprinting company headquartered in Groton, Conn., has been pioneering an on-demand tissue manufacturing solution as a service model. As the FDA has confirmed the 510 (k) clearance eligibility for the company’s 3D-printed bioceramic and modified biopolymer bone implants, the first step is nearing completion.
Butterfly Network Inc., of Guilford, Conn., and the American College of Cardiology, of Washington, are joining forces to transform the use of ultrasound within cardiology using the Butterfly Iq+. Earlier this week, Butterfly revealed the release of its next-generation ultrasound product, Butterfly Iq+, the world's only single-probe, whole-body ultrasound system that connects to a mobile device and features an integrated telemedicine platform.
Friendswood, Texas-based Castle Biosciences Inc. said that Columbia, S.C.-based Palmetto GBA Moldx, has issued a final expanded local coverage determination (LCD) for the company's Decisiondx-Melanoma test. The LCD effective date is Nov. 22. Details on the LCD and the billing and coding article are posted to the Medicare Coverage Database on the U.S. Centers for Medicare and Medicaid Services website.
Cb Scientific Inc., of Escondido, Calif., reported the targeted launch of cardiac lab services in Thailand through its exclusive distributor, Mango Wellness Co Ltd. and My Cardia Thailand Co. Ltd., both of Bangkok.
Bellevue, Wash.-based Curvafix Inc. reported the treatment of the first U.S. patient in its RESTORE clinical study, a safety and technical feasibility evaluation of the Curvafix Intramedullary Rodscrew for fixation of pelvic and acetabular fractures. The procedure was performed at the University of Texas Health Science Center at Houston.
Indianapolis-based Eli Lilly and Co. and Dexcom Inc., of San Diego, are teaming up on a program to improve diabetes management. Specifically, the companies will partner to promote Lyumjev, Lilly’s new rapid-acting insulin, with the Dexcom G6 continuous glucose monitoring system, highlighting the benefits of using each.
Waltham, Mass.-based Fresenius Medical Care North America (FMCNA) reported a partnership with Livongo Health Inc., of Mountain View, Calif., with an eye toward improving the lives and outcomes of people with late-stage chronic kidney disease (CKD). The new partnership will aim to enable Fresenius Health Partners, a division of FMCNA, to better deliver targeted, real-time care coordination services through Livongo Whole Person for CKD.
Isoplexis Corp., of Branford, Conn., is partnering with Yale University to use Isoplexis’ functional immune landscaping and high-plex automated immunoassay solutions to identify various predictive markers of immune response to COVID-19.
Kilkenny, Ireland-based Mybio Ltd. has partnered with Mölab GmbH, of Unna, Germany, to bring Mölab’s COVID-19 Rapid Antigen Test to the Irish market. In a white paper released this week, Mybio reported the test has a 99% accuracy rate, with 97.3% sensitivity and 99.9% specificity.
Nanovibronix Inc., of Elmsford, N.Y., received a positive determination for continued listing on the Nasdaq Capital Market pursuant to an extension through Dec. 15, 2020, to demonstrate compliance with the minimum $2.5 million stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b).
Oslo-based Nec Oncoimmunity AS, a subsidiary of Nec Corp., and Oslo University Hospital have been awarded a grant from the Research Council of Norway to develop an artificial intelligence platform that will enable the rapid design of T-cell diagnostics for emerging or endemic infectious diseases. The project will develop a novel T-cell diagnostic for COVID-19 to complement current serological tests. The amount of the award was not disclosed.
Irvine, Calif.-based Oncocyte Corp. has forged a strategic collaboration with the Fondazione Michelangelo in Milan, Italy, to evaluate Determalo as a biomarker for response in the NeoTRIPaPDL1 trial. The biomarker trial is a prospectively designed, retrospective analysis of archived study material from the therapeutic trial in triple-negative breast cancer.
Rhythm AI Ltd., of London, said it has received approval from the U.K. Medicines and Healthcare Products Regulatory Agency to proceed with its multicenter ROCSTAR clinical trial. This program will assess the company’s artificial intelligence (AI)-based Star mapping system as a potential treatment for persistent atrial fibrillation.
Scanwell Health Inc., of Los Angeles, reported the expansion of the COVID-19 Community Research Partnership in North Carolina. Currently, thousands of study participants are testing regularly using Scanwell’s at-home test kits to detect antibodies to the novel coronavirus. With the expansion, Scanwell will distribute over 200,000 test kits by the end of the year in partnership with existing and new study sites. The year-long serosurveillance study, led by Wake Forest Baptist Health, began in April with the aim of helping the medical community better understand the COVID-19 pandemic.
The University of California San Francisco’s Center for Digital Health Innovation (CDHI); Fortanix Inc., of Mountain View, Calif.; Intel Corp., of Santa Clara, Calif.; and Microsoft Corp., of Redmond, Wash., reported they have formed a collaboration to establish a confidential computing platform with privacy-preserving analytics to accelerate the development and validation of clinical algorithms. The platform will provide a zero-trust environment to protect both the intellectual property of an algorithm and the privacy of health care data, while CDHI’s proprietary BeekeeperAI will provide the workflows to enable more efficient data access, transformation, and orchestration across multiple data providers.