Endpoint Health Inc. has made its official debut, scooping up $12 million in debt and equity financing from a host of investors, including Mayfield, Y Combinator, Ame Cloud Ventures and Wireframe Ventures. The Palo Alto, Calif.-based company is focused on helping people with illnesses such as sepsis and acute respiratory distress syndrome (ARDS) – life-threatening conditions often caused by serious infections, including COVID-19.
Thermo Fisher Scientific has joined forces with First Genetics JCS to commercialize next-generation sequencing (NGS) diagnostics in Russia. The agreement allows Moscow-based First Genetics to bring its F-Genetics NGS system and in vitro diagnostic assays for reproductive health testing to Russian labs.
New England Biolabs Inc. (NEB) has launched its research use only product that can be utilized for the detection of the novel coronavirus, SARS-CoV-2 RNA. It is intended to serve as an alternative to RT-qPCR, enabling visual detection of amplification of SARS-CoV-2 nucleic acid in half an hour.
The U.S. Preventive Services Task Force (USPSTF) may recommend a fairly dramatic expansion of the populations that would be eligible for coverage for lung cancer screening, a bit of news that might be expected to cheer makers of CT imaging systems. However, compliance with the existing recommendations is already quite low, suggesting that an expansion of eligibility is likely to exert a negligible effect at best on utilization.
Infervision Technology Co. Ltd. has received the green light from the U.S. FDA for its Inferread Lung CT.AI product. The artificial intelligence- and deep learning-based technology automatically performs lung segmentation and identifies and labels different types of lung nodules. According to the 510(k) notification, Inferread Lung CT.AI “is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population.”
Biointellisense Inc. received an FDA clearance in January for its Biosticker to monitor patient vital signs at home for as long as 30 days. It was just starting to launch, when along came the novel coronavirus. Now, the Band-Aid-sized monitor is being used to monitor COVID-19 patients at home, as well as chronic disease patients.
The use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making may seem more aspirational than practical at times, but that state of affairs is changing rapidly. Wendy Rubenstein, director of personalized medicine at the U.S. FDA’s Center for Devices and Radiological Health, said contemporary versions of these real-world sources of evidence “are of progressively higher quality” in recent years, and thus RWE and RWD may soon hit their strides as mature sources of data with which regulators are increasingly comfortable.
HONG KONG – Hong Kong’s emerging med-tech sector is getting a boost from a government-funded program aimed at sharing technology with other jurisdictions, a program driven in part by the need to contain the COVID-19 pandemic and continue opening regional economies.
Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.