The University of Missouri Research Reactor (MURR) recently shipped its first batch of a medical isotope used to diagnose and treat thyroid cancer, making it the first domestic source of Iodine-131 (I-131) in 30 years. I-131 has only an eight-day half-life, making stockpiling impossible, and demand is expected to increase. Thyroid cancer is “the most rapidly increasing […]
Blue Spark wins CE Mark for wearable, wireless TempTraq monitor
Medtech developer Blue Spark Technologies said today it won CE Mark approval in the European Union for the TempTraq bluetooth wearable temperature monitor. The TempTraq system is a disposable, wearable continuous temperature monitoring patch that wirelessly delivers temperature readings, the Cleveland-based company said. The system includes the ability to set alerts, which are sent to […]
FDA issues Class I recall for Roche Diagnostics’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The FDA said today […]
FDA clears 23andMe for pharmacogenetics testing
The FDA recently cleared a pharmacogenetic DNA test from 23andMe that is designed to determine how users will react to certain pharmaceutical drugs. The FDA cleared the new 23andMe test to give information on 33 genetic variants that determine how patients will respond to more than 50 different prescribed and over-the-counter medications. The test, which […]
Prevent Biometrics acquires X2 Biosystems head impact monitoring assets
Head impact monitoring tech developer Prevent Biometrics said last week it acquired the head impact monitoring assets of Seattle-based X2 Biosystems for an undisclosed amount. Minneapolis-based Prevent Biometrics, which spun-out of the Cleveland Clinic in 2015, said that the acquisition will bring together its own Impact Monitor Mouthguard and X2’s skin patch-based platform. Prevent Biometrics […]
The top 10 medical disruptors of 2019
The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year. The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150. […]
Masimo wins FDA nod for improved RD SET sensors
Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its RD SET sensors with measure-through motion and low perfusion SET pulse oximetry. The newly cleared sensors feature improved SpO2 accuracy specifications for patients under 3kg, the Irvine, Calif.-based company said, and are designed to improve accuracy, patient comfort and clinician workflows. “We’re delighted to be […]
Philips wins FDA nod for IntelliVue GuardianSoftware mobile app
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its IntelliVue GuardianSoftware mobile client application, designed to allow clinicians to view patient vital signs and receive early warning scores on mobile devices. The Amsterdam-based company said that the system is intended to move information that would normally be manually recorded in hospital medical-surgical units […]
Siemens Healthineers, Healthy.io ink home kidney monitoring deal
Siemens (NYSE:SI) Healthineers said today it inked a deal with Healthy.io looking to improve home chronic kidney disease monitoring. Through the deal, the companies will look to offer a home-based alternative to periodic urine testing to monitor kidney function, which requires patients travel to a clinician’s office. Siemens said it will supply urinalysis reagents which will be […]
Teleflex, Arcis enter agreement for cancer diagnostics
Cancer-detection company Arcis Biotechnology said today it has signed an agreement allowing Teleflex (NYSE:TFX) to use Arcis’ advanced nucleic acid sample preparation chemistry in the development of a novel technology. Daresbury, England-based Arcis’ diagnostics use a two-step nucleic acid extraction and preservation technology. The company said it has an extensive patent portfolio covering DNA and […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
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