Ortek Therapeutics Inc., of Roslyn Heights, N.Y., has officially launched its electronic early cavity detection system, the Ortek-ECD. The U.S. FDA-cleared device can detect dental lesions before they show up on X-rays, enabling less invasive treatment and preventing greater damage to the tooth structure. Ortek holds the exclusive license for the device which was developed at Stony Brook University School of Dental Medicine.
Deep Lens Inc. has integrated molecular data parsing and management technology into its Viper clinical trial screening and enrollment platform, enabling automated matching of patients with eligible genetic profiles to clinical trials. The Columbus, Ohio-based company licensed the proprietary technology from the University of Miami.
Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs.
The FDA granted Setpoint Medical Corp. an investigational device exemption (IDE) approval to study its bioelectronic platform in rheumatoid arthritis (RA) patients. The Valencia, Calif.-based company expects to begin enrollment in a multicenter, double-blind, randomized, sham-controlled pivotal trial in patients with RA in the third quarter of 2020, Setpoint President and CEO Murthy Simhambhatla told BioWorld.
Palo Alto, Calif.-based Limbix Health Inc. secured $9 million in series A funding for development of Spark, its prescription digital therapeutic (PDT) designed to treat depression in adolescents. GSR Ventures led the round with additional funding from other existing investors, including Sequoia Capital, Storm Ventures, Nextgen Venture Partners and Bixink Therapeutics.
Zoll Medical Corp., of Chelmsford, Mass., received CE mark approval to market its second-generation Supersaturated Oxygen (SSO2) Therapy in Europe and other countries that accept CE mark. The therapy, which delivers hyperbaric levels of oxygen to the ischemic heart muscle immediately following percutaneous coronary intervention, has been shown to significantly reduce damage to the heart muscle after an acute myocardial infarction.
Researchers in Guangzhou, China, have developed a nanoparticle-based lateral flow immunoassay that quickly and accurately detects antibodies to the SARS-CoV-2 virus that causes COVID-19. The current test, which works in a similar manner to a pregnancy test, detects IgG antibodies in blood in less than 10 minutes. A proof-of-concept study appeared in Analytical Chemistry this week.
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.
Armonk, N.Y.-based International Business Machines Corp. (IBM) launched the Rapid Supplier Connect network to help government agencies and health care organizations tap into new, non-traditional suppliers now producing devices and equipment needed to battle COVID-19. Membership in the blockchain-based network is free through Aug. 31, 2020, to qualified participants.
