MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection. Read More
LONDON – Liquid biopsy specialist Inivata Ltd. has been granted a U.S. FDA breakthrough device designation for its Radar assay for detecting residual disease or relapse, following treatment for cancer. The personalized assay, which tracks a set of up to 48 genetic variants isolated from excised tumor tissue, is built on Inivata’s approved Invision platform for detecting circulating tumor DNA (ctDNA) in blood samples. Read More
Mahana Therapeutics Inc. obtained a CE mark for Parallel, a prescription digital therapeutic device to treat irritable bowel syndrome (IBS) in conjunction with other IBS treatments. Developed by a team of U.K. psychologists, the three-month program delivers cognitive behavioral therapy (CBT) via a web-based application. Read More
The first day of the annual meeting of the American Clinical Laboratory Association (ACLA) included a brief address by two members of Congress, including Rep. Brett Guthrie (R-Ky.), who chairs the health subcommittee of the House Energy and Commerce Committee. Guthrie acknowledged that the reset of the Medicare clinical lab fee schedule was not going as intended, but declined to identify any possible fixes pending a report by the Medicare Payment Advisory Commission. Read More
With the prevalence of central nervous system disorders such as Alzheimer’s disease, multiple sclerosis, epilepsy, Parkinson’s disease and stroke increasing annually, the need for novel therapeutics to treat neurologic and psychiatric disorders has never been greater. Unfortunately, even though there is a significant unmet medical need, because of the high risk and low approval rates of drugs targeting those devastating diseases, in the past decade big pharma companies have been dramatically reducing their R&D spending on CNS disorders, noted Naheed Kurji, president and CEO of Toronto-based Cyclica Inc. Read More
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akesis, Breath Direct, Clew, Datar Cancer Genetics. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Stimulus passes, no Medicare sequestration relief; OIG cites improper claims for polysomnography; Four senators seek feedback on Section 101 hangup. Read More
Keeping you up to date on recent developments in orthopedics, including: Injectable porous scaffolds promote better, quicker healing after spinal cord injuries; Researchers grow most lifelike bone yet from woven cells; Rapid 3D printing method moves toward 3D-printed organs; Study links kidney stones with bone problems. Read More
