Prairie Village, Kan.-based Artio Medical Inc. has successfully completed the first human use of its Amplifi vein dilation system. The first clinical procedure was performed by Adrian Ebner, the head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asuncion, Paraguay. Artio acquired the Amplifi technology through the acquisition of Flow Forward Medical Inc. in June 2020. The system aims to address common issues related to vascular access site creation and maintenance for the 2.3 million patients worldwide with end-stage renal disease who require hemodialysis. Artio expects to complete the first-in-human clinical study in the first half of 2021.
CDx Diagnostics Inc., of Suffern, N.Y., said Wats3D, an artificial intelligence-powered diagnostic platform to identify precancerous and cancerous cells in the esophagus, is now considered a medically necessary service by Bluecross Blueshield of South Carolina. The health insurance carrier will now cover Wats3D testing for over 1.2 million members.
Denver-based Healthstat, a part of Everside Health, which was created from the merger of Paladina Health, Activate Healthcare and Healthstat, reported its partnership with San Diego-based Dexcom Inc. to offer Dexcom continuous glucose monitoring (CGM) to its patients with type 2 diabetes. The new partnership marks the first time an onsite health care provider is offering the Dexcom G6 CGM system to its employer- and union-based patients.
Electrocore Inc., of Rockaway, N.J., said its Gammacore Sapphire noninvasive vagus nerve stimulation therapy has been included in NHS England and NHS Improvement’s Medtech Funding Mandate Policy 2021/22, which takes effect April 1, 2021.
Freedom Fries LLC, of Evanston, Ill., has partnered with Salt Lake City-based Medsential LLC for the distribution of its U.S. FDA-authorized, 15-minute Fastep COVID-19 IgM/IgG Rapid tests for immediate delivery at point-of-care locations.
Irvine, Calif.-based Gatc Health Corp. and Liquid Biosciences Inc., of Aliso Viejo, Calif., have teamed up to discover disease biomarkers and identify potential treatments. The initial pipeline of diseases slated for evaluation includes a variety of neurological diseases with significant unmet needs.
Heartflow Inc., of Redwood City, Calif., said NHS England and NHS Improvement have mandated that English hospitals adopt its artificial intelligence-powered Heartflow fractional flow reserve (FFRct) analysis to fight coronary heart disease.
The International Development Innovation Alliance and World Health Organization signed a strategic collaborative agreement to support the scaling of health innovations, with a focus on innovations that benefit low- and middle-income countries.
Sarasota, Fla.-based Invo Bioscience Inc. said it has advanced its commercialization efforts into the European fertility market by securing an initial order of Invocell in Spain.
Lunit Inc., a medical artificial intelligence software company headquartered in Seoul, South Korea, has partnered with Infinitt Healthcare Co. Ltd., of Seoul, a picture archiving and communications systems provider, to accelerating global expansion and aid in COVID-19 screening and diagnosis.
Microbot Medical Inc., of Hingham, Mass., said discussions with the U.S. FDA about its self-cleaning shunt were successfully completed and it can move forward with its application for an early feasibility study. The company expects to begin a first-in-human trial in the third quarter of 2022.
Nextech Systems LLC, a Tampa-Fla.-based health care technology solutions provider for specialty physician practices, said it acquired Austin-based Mymedleads, a patient engagement and marketing software company. Financial terms were not disclosed.
Singapore-based Osteopore International Pte. Ltd., in collaboration with Maastricht University Medical Centre, has successfully developed a bioresorbable 3D-printed cage that prevents leg amputations in patients with severe lower leg fractures. The device helps patients regenerate new bone cells and has been implanted in its first patient in the Netherlands.
Ra Medical Systems Inc., of Carlsbad, Calif., reported progress with extending the shelf life of its next-generation Dabra catheter, featuring a braided overjacket to improve durability when navigating tortuous anatomy. The company also reported the completion of all 116 items identified in a quality improvement plan that stemmed from an internal audit in late 2019, with enhancements to standard operating procedures, preventive maintenance, equipment status, and calibrations and supply quality.
Amsterdam-based Royal Philips NV launched the Philips Abdominal Aortic Aneurysm (AAA) Model, integrating 3D ultrasound with innovative software for improved surveillance of AAAs.
Soterix Medical Inc., of New York, reported a new clinical trial of home-based transcutaneous auricular vagus nerve stimulation for individuals who experience post-COVID neuropsychiatric symptoms, like fatigue, headache or anxiety.
Spectrum Solutions LLC, of Salt Lake City, reported a research collaboration with the UCLA School of Dentistry for a study on using saliva in early lung cancer detection and analysis. Spectrum has funded a study that aims to recruit 50 patients with non-small-cell lung cancer and seeks to validate saliva’s tumor-specific cell-free circulating tumor detection sensitivity and positive agreement against tissue biopsy-based genotyping. Saliva will be collected, preserved and transported for DNA testing using Spectrum’s saliva collection system.
Theralink Technologies Inc., a Golden, Colo.-based precision medicine molecular profiling company with a novel phosphoprotein-based laboratory developed test, said it has begun the testing of the first patients with its reverse phase protein array (RPPA) technology. The initial use for the Theralink assay is for patients with breast cancer.
Memphis-based Transnetyx Inc. and One Codex, of San Francisco, are collaborating on an end-to-end microbiome sequencing and analysis service for both mice and humans.
Triple Ring Technologies Inc., a medical device and life sciences co-development partner headquartered in Newark, Calif., said it is now operating in Copenhagen, Denmark, and Toronto.
Valcare Medical Ltd., of Herzliya, Israel, reported the first-in-human transseptal implant of its Amend annuloplasty ring. The procedure was performed at the Schulich Heart Centre at Sunnybrook Health Sciences Centre in Toronto, under the Health Canada Special Access Program.
Verana Health Inc., of San Francisco, entered a research collaboration agreement with Janssen Research & Development LLC, of Raritan, N.J. The collaboration will focus on curating real-world data and driving data science applications in the areas of ophthalmology and urology.