Alivecor Inc., of Mountain View, Calif., reported an expanded range of electrocardiogram determinations on its Kardiamobile devices. These new determinations are cleared by the U.S. FDA as of November 2020 and include sinus rhythm with supraventricular ectopy (SVE), sinus rhythm with premature ventricular contractions (PVCs), and sinus rhythm with wide QRS. Alivecor's new determinations will include a refined algorithm for detection of atrial fibrillation, improving sensitivity and specificity and reducing the number of unclassified readings, false negatives, and false positives.
Theale, England-based Althea UK and Ireland Ltd., a medical technology services provider, is now offering SARS-CoV-2 rapid antigen tests from Basel, Switzerland-based Roche Holding AG. Althea hopes that the new service, which is available for pharmacies, dentists, hospitals and clinics, as well as hospital support companies whose staff access clinical settings, will provide a valuable initial screening test for staff who might be exposed to COVID-19 or work in high-risk environments.
Menlo Park, Calif.-based Avails Medical Inc. was awarded up to $2.5 million in non-dilutive funding from Carb-X, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator. Carb-X is a global non-profit partnership based at Boston University School of Law and dedicated to funding the development of new antibiotics, vaccines, diagnostics and other products to address antibiotic-resistant bacteria. Funds will support the development of Avails’ East technology, a fully electrical antibiotic susceptibility testing device to reduce the time-to-results and enable health care providers to rapidly determine the most effective antibiotic treatment for patients with severe bloodstream infections, especially those involving multidrug-resistant pathogens. The company will be eligible for an additional $14.7 million in non-dilutive funding from Carb-X upon successful completion of milestones.
Kennewick, Wash.-based Cadwell Industries Inc. reported the acquisition of the Sleepmate line of sleep diagnostic sensors from Ballerup, Denmark-based Ambu A/S. No further details of the transaction were given.
Los Angeles-based Capricor Therapeutics Inc. has received from Johns Hopkins University a non-exclusive license to intellectual property, know-how and data related to a new imaging-based serology test platform for COVID-19. This platform, which is amenable to a vast array of serology applications, has been applied to the analysis of patient antibodies to multiple SARS-CoV-2 proteins, including spike, nucleocapsid, and membrane. The technology as described in the publication demonstrates several key advantages of imaging-based serology, which includes in-sample negative controls and gating of signal strength by specificity of signal pattern, capture of antibodies to proteins in their native conformations and environment within human cells, and the potential for simultaneous interrogation of multiple target proteins.
St. Paul, Minn.-based Cardiovascular Systems Inc. (CSI) has partnered with Aptos, Calif.-based Chansu Vascular Technologies LLC (CVT) to develop peripheral and coronary everolimus drug-coated balloons (DCBs). CSI will provide milestone-based financing to CVT for the development of the DCBs. Under an acquisition option agreement, upon CVT’s completion of key technical and clinical milestones in the development program, CSI will have exclusive rights and obligations to acquire CVT, subject to the satisfaction of closing conditions set forth in the agreement.
Pasadena, Calif.-based Circularity Healthcare LLC reported the expansion with Professional Educational Research Institute, a global contract research organization, of a series of pivotal clinical trials to study the use of D’Oxyva for the noninvasive home treatment of diabetic foot ulcers (DFU). The new trial will assess the use of D’Oxyva to help prevent amputations and treat DFUs at one-tenth the time and coast and with at least fives the efficacy of competing modalities.
Earlysense Ltd., of Ramat Gan, Israel, has sold its continuous monitoring technology to Chicago-based Hillrom. Earlysense will receive licensing for all intellectual property and technology sold to Hillrom for use outside the hospital, as well as a cash consideration of $30 million, potential payments based on the achievement of certain commercial milestones and a portion of Hillrom’s equity investment in Earlysense.
Exactech Inc., of Gainesville, Fla., has launched the next-generation hardware and software for its Exactechgps guided personalized surgery system.
Richardson, Texas-based Fuse Medical Inc. reported an agreement with Orthovestments LLC, of Marietta, Ga., for the exclusive manufacturing and commercialization of the Orbitum staple system for the U.S. market. Initial launch is expected in the beginning of second quarter of 2021.
Innova Medical Group Inc., of Pasadena, Calif., said its SARS-CoV-2 Antigen Test kits have successfully detected the several mutated strains that have become more widespread around the world in recent weeks, including the U.K., South African and Brazilian variants.
Laborie Medical Technologies Inc., of Burlington, Mass., in partnership with Urotronic Inc., of Plymouth, Minn., reported that the first Optilume procedures were performed in Mannheim, Germany on Jan. 22, 2021, by Georgi Tosev. The Optilume drug-coated balloon technology was recently granted CE mark approval for use in urethral strictures. Urotronic is conducting clinical trials in the U.S. to support approval of Optilume for urethral strictures and benign prostatic hyperplasia.
Researchers from the Mayo Clinic, of Rochester, Minn., said they trained and validated an artificial intelligence (AI)-based deep neural network to detect QTc prolongation using Alivecor Inc.'s Kardiamobile 6L electrocardiogram (ECG) device. The findings, which were published in Circulation, compared the ability of an AI-enabled mobile ECG to a traditional 12-lead ECG in detecting QT prolongation. The algorithm, dubbed QT meter, was tested prospectively on nearly 700 patients, and the study found that half of these patients had congenital long QT syndrome. The mobile device effectively detected a QTc value of greater than or equal to 500 milliseconds, performing with 80% sensitivity and 94.4% specificity.
Seoul, South Korea-based Seegene Inc. said it has developed the world’s first COVID-19 diagnostic variant test, capable of screening COVID-19 and identifying multiple variants in a single reaction. The Allplex SARS-CoV-2 Variants I Assay can identify major genetic variations including ones originating in the U.K., South Africa, Brazil and Japan.
Senseonics Holdings Inc., of Germantown, Md., said Ascensia Diabetes Care Holdings AG, of Basel, Switzerland, has commenced sales and marketing activities for the Eversense XL continuous glucose monitoring system in Europe. According to the strategic partnership announced in August 2020, Ascensia will distribute the product in Germany, Italy, the Netherlands, Poland, Spain and Switzerland.
Setpoint Medical Corp., of Valencia, Calif., reported the enrollment of the first patient in its RESET-RA study. The IDE-approved study will evaluate the safety and efficacy of the company’s bioelectronic platform in patients with rheumatoid arthritis. It will enroll up to 250 patients at 40 sites in the U.S. The primary efficacy endpoint is the proportion of patients achieving an ACR20 response in the treatment vs. sham groups at 12 weeks.