Cardiac monitoring company Rhythmedix Inc. reported the launch of its next-generation, wearable Rhythmstar device with built-in 4G cellular connectivity. The low-profile, water-resistant cardiac telemetry monitor provides extended remote monitoring to quickly detect arrhythmia without the need for a phone or other communication device. Read More
HONG KONG – The third pre-revenue med-tech firm to list on the Hong Kong Stock Exchange in a month, New Horizon Health Technology Co. Ltd. raised HK$1.9 billion (US$245.08 million) in an IPO that began trading Thursday, Feb. 18. New Horizon placed 76.6 million shares at HK$26.66 apiece and said part of the funds will help the company commercialize its FIT-DNA test Coloclear to screen for colorectal cancer. Read More
Emitbio Inc., a life science company developing light-based therapies, is seeking emergency use authorization (EUA) from the U.S. FDA for its investigational device to treat mild to moderate COVID-19 infection at home. The portable, hand-held device works by directing precise wavelengths of visible light to the back of the throat and surrounding tissues. It is not yet available for sale in the U.S. Read More
If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled. Read More
Researchers at the University of California San Diego (UCSD) have taken wearables to a new level with a soft skin patch that integrates functions currently siloed in continuous glucose monitors, wearables, wellness apps and hospital monitors. The all-in-one patch can be worn on the neck to continuously track blood pressure, heart rate, glucose, lactate, alcohol and caffeine. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, Campbell Neurosciences, Caption Health, Elucid. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Clearpoint Neuro, Exem Foam, Healthmode, Mindmed, New Horizon Health, Philips, Viewpoint Molecular Targeting. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Additive Orthopaedics, FX Shoulder, Medtronic. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD offers little detail in reaction to advisory hearing; FDA invites stakeholders to user fee negotiations; MHRA wary of paclitaxel. Read More
Keeping you up to date on recent developments in diagnostics, including: Urine offers early clues to cancer, Improving detection of esophageal cancer; PanFAM-1 study nears completion. Read More
