Updated Jan. 12 to include a statement from BD. The FDA issued a warning letter to Becton Dickinson & Co. (NYSE:BDX) today, citing a number of violations of federal law that it identified in an inspection of the company’s New Jersey facility. The inspection, which was done as part of the agency’s ongoing investigation into the […]
Diagnostics
Masimo wins home-use indication for Rad-97 pulse CO-Oximeter
Masimo (NSDQ:MASI) said today it won FDA clearance clearing its Rad-97 pulse CO-Oximeter for home use. The Irvine, Calif.-based company said the Rad-97 monitor features NomoLine capnography and noninvasive blood pressure monitoring technology from SunTech Medical, as well as its own continuous monitoring and SET pulse oximetry with upgradable rainbow tech. The Rad-97 includes a multi-touch […]
Check-Cap wins CE Mark for C-Scan diagnostic capsule
Check-Cap (NSDQ:CHEK) said today it won CE Mark approval in the European Union for its C-Scan ingestible sensor capsule designed for colorectal cancer screening. The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless tracking system to return structural […]
Siemens Healthineers closes Fast Track Diagnostics buy
Siemens (NYSE:SI) Healthineers said today it completed its acquisition of Fast Track Diagnostics, marking the official date of the closing as December 19, 2017. With the acquisition, FTD’s sites in Luxembourg, Malta and India and its approximately 80 employee workforce will be folded into Siemens Healthineers business. FTD produces a range of CE Mark approved infectious disease […]
Study: Ingestible sensors used to measure, detail gut gas profiles
Ingestible sensors could be used to monitor gasses in the gastrointestinal system, including the effects of diet on individuals and as diagnostic tools for stomach contents and health, according to a new study. Results from the study which explored the use of new ingestible sensors were published this month in the journal Nature Electronics. In […]
Zoll Medical wins US Army contract for Propaq M vital signs monitors
Zoll Medical said this week it won a sole-source contract from the US Defense Logistics Agency to supply Propaq M deployable vital signs monitors to the US Air Force and US Army. The Chelmsford, Mass.-based company’s Propaq M is an advanced vital signs transport monitor designed for military operations. The system can be equipped with an […]
Masimo wins CE Mark for RD Rainbow Lite SET sensors
Masimo (NSDQ:MASI) said today it won CE Mark approval in the European Union for its RD Rainbow Lite SET sensors designed to monitor the company’s proprietary Masimo oxygen reserve index and RPVi. The Irvine, Calif.-based company said the rainbow Lite sensors use twice as many wavelengths of light as the company’s SET sensors, enabling ORi and […]
Abbott wins CE Mark for Alinity h-series hematology system
Abbott (NYSE:ABT) said today it won CE Mark approval in the European Union for its Alinity h-series integrated hematology testing system and that it launched the device in the associated regions. The newly cleared system features integration of the Alinity hq system with the Alinity hs slide marker and stainer module. The company touts the system […]
This test can detect when your body is fighting a virus
A test that measures the RNA or protein molecules in human cells is also able to detect when your body is fighting a viral infection from respiratory symptoms, according to Yale researchers. The test involves a nasal swab and could be a faster and cheaper way to diagnose respiratory viral illnesses. “It’s a simpler test […]
5 medtech stories we missed this week: Dec. 22, 2017
From Hepa Wash’s new collaboration to Stimwave’s FDA clearance, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Hepa Wash collaborates with GALS program Hepa Wash announced in a Dec. 7 press release that it has collaborated with the German Accelerator Life Sciences (GALS) program to expand its […]
TearLab cuts headcount in restructuring effort
TearLab Corp. (OTC:TEAR) is looking to keep its customer base and reduce the company’s cash burn rate with a new business model that will result in people losing their jobs, according to regulatory filings. The company said that it wants to focus resources on the development of its next-gen TearLab Discovery platform. Get the full story at […]