Abbott (NYSE:ABT) landed a contract with the U.S. Defense Dept. to develop a diagnostic assay to detect traumatic brain injuries, the Pentagon said yesterday. The Chicago-area healthcare giant was the lone bidder for the $35.2 million fixed-price contract, with an estimated completion date of Aug. 31, 2022. The deal also comes with an immediate $12 […]
Diagnostics
T2 Biosystems wins FDA breakthrough nod for drug resistance blood test
T2 Biosystems (NSDQ:TTOO) said yesterday that it won FDA breakthrough device designation for its T2Resistance Panel diagnostic designed to detect 13 drug resistance genes from a blood sample. The T2Resistance Panel is designed to identify 13 genes that the Lexington, Mass.-based company said include “the most clinically important.” This includes genes that indicate a resistance […]
FDA clears Mauna Kea Technologies system for lung cancer detection
Paris-based Mauna Kea Technologies (ENT:MKEA) said that it has received 510(k) clearance from FDA for the use of the Cellvizio AQ-Flex 19 Confocal Miniprobe through existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories to detect lung cancer. Cellvizio is a multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform designed to aid clinicians in the diagnosis and treatment […]
Eye-disease AI detection software dev Pr3vent closes Series A
Ophthalmic-focused artificial intelligence dev Pr3vent said yesterday that it closed an undisclosed Series A round of financing to support its machine-vision based system intended for detecting eye disease in newborns. The round was led by InFocus Capital Partners, the Palo Alto, Calif.-based company said, and follows a successful seed round last October jointly led by […]
BioDirection wins FDA breakthrough designation for Tbit concussion detection system
BioDirection said today that it won an FDA breakthrough device designation for its Tbit point-of-care blood test for concussion diagnosis. The Boston-based company’s Tbit system is designed to rapidly detect and accurately measure protein biomarkers that are released from the brain following a head trauma. “We are pleased to receive this FDA designation and believe it […]
Here’s how precision medicine could change medical imaging
The business of precision medical imaging is poised to take off in the next few years, according to a new analysis by Frost & Sullivan. The market research firm’s report, “Growth Opportunities in Precision Medical Imaging, Forecast to 2022,” said new technologies and processes in diagnostic and therapeutic imaging could spur the market to grow […]
FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage. The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, which […]
CathWorks raises $30m in Series C
CathWorks said today that it closed a $30 million Series C round of financing to support its FFRangio non-invasive fractional flow reserve tech. The FFRangio system is designed to provide objective FFR guidance for optimizing percutaneous coronary intervention therapy decisions, the Israel-based company said. FFRangio is derived from routine X-rays during diagnostic angiogram procedures and is […]
Oxipit wins CE Mark for AI-powered chest imaging suite
Medical imaging tech dev Oxipit said today that it won CE Mark approval in the European Union for its ChestEye radiology imaging suite. The ChestEye system is designed to provide analysis and preliminary reports for 75 of the most common radiological findings, Oxipit said. The system localizes its findings on a radiograph as a heatmap […]
FDA sets March dates for microbiology, neurology device panel meetings
The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases. In the microbiology devices panel meeting, slated to be held March 8, a committee of microbiology device experts will […]
Perspectum wins FDA nod for biliary duct mapping software
Perspectum Diagnostics said this week that it won 510(k) clearance from the FDA for its biliary visualization software, MRCP+. The company’s AI-powered software is designed to provide improved visualization, monitoring and reporting of intra-hepatic ducts. The metrics produced by MRCP+ could be particularly useful for doctors monitoring patients with primary sclerosing cholangitis, according to Perspectum […]