Baxter (NYSE:BAX) said today that it inked a partnership deal with Biomérieux looking to develop biomarkers to identify acute kidney injury. The partnership was announced at the International Symposium on Intensive Care and Emergency Medicine, Deerfield, Ill.-based Baxter said. Both companies said they hope to develop the biomarkers to help rapidly identify and inform treatment of acute […]
Lessons learned from Lantheus CEO Mary Anne Heino
At MassMedic’s Women in Medtech event last month, Lantheus Medical Imaging CEO Mary Anne Heino spoke with MassDevice.com editor Sarah Faulkner about her career in life sciences, the power of mentorship and the necessity of courage. When Mary Anne Heino first joined Lantheus Medical Imaging (NSDQ:LNTH) in 2013, she knew admittedly very little about the […]
T2 Biosystems shares tumble on 2018 earnings release
Shares in T2 Biosystems (NSDQ:TTOO) have fallen nearly 20% today after the diagnostics maker posted its full year 2018 earnings. For the full year, the Lexington, Mass.-based company posted losses of $51.2 million, or $1.26 per share, on sales of $10.5 million, seeing losses shrink 18.1% while sales grew 125% compared with the previous year. For […]
Masimo wins CE Mark for next-gen SedLine pediatric brain monitor
Masimo (NSDQ:MASI) said today that it won CE Mark approval in the European Union for its next-gen SedLine brain function monitor intended for pediatric patients. The Irvine, Calif.-based company said that with the clearance, its next-gen SedLine monitoring tech is now available for all patients one year and older in CE Mark countries. Masimo said that […]
Abbott wins $35m Defense contract for TBI assay
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 […]
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 […]
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