Ontera has signed a deal with QuantuMDx to develop technology to detect bloodstream infections and drug resistance using Ontera's nanopore biosensor and QuantuMDx's Capture-XT preparation technology. The firms did not disclose the financial details of the deal.
Inscripta, a startup that has developed a benchtop automated genome engineering instrument, raised $125 million in its most recent funding round. The company plans to use the new capital to commercialize the Onyx Digital Genome Engineering platform and broaden its applications.
Adaptive Biotechnologies and AbbVie will collaborate on use of the former's clonoSeq assay to determine patients' minimal residual disease status in various trials assessing venetoclax as a treatment for multiple myeloma. No other disclosures were made regarding the terms of multi-year, global deal.
The FDA has cleared a new application in orthopedic trauma for Orthogrid Systems' intraoperable PhantomMSK platform. The PhantomMSK aids in aligning bone fractures and improves intraoperative efficiency using artificial intelligence-trained and augmented reality-based decision support.
Abbott is warning of two issues with its advanced heart failure implant. Incorrect connection of the HeartMate 3 modular cable can cut electrical power to the pump, while separate reports cite power loss to HeartMate mobile power unit modules caused by static electricity.
A report from WebMD and Georgia Health News shows people living about a mile away from a Medline sterilization plant have blood levels of ethylene oxide that are 50% higher than those who live farther. However, participants were not randomly selected and the results may be biased and have not been published in a peer-reviewed publication.
Seventh Sense Biosystems has obtained 510(k) clearance from the FDA for its Tap, a push-button blood collection device for use by laypersons.
The FDA has issued warning letters to Teligent Pharma and OHM Pharma over violations of good manufacturing practices.
Teligent was cited for not thoroughly investigating of out-of-specification test results for a lot of clobetasol propionate before distributing it two years ago, while OHM was cited for issues with cleaning, laboratory controls and manufacturing practices.
The Australian Therapeutic Goods Administration has warned that Mylan's epinephrine injection EpiPen Jr will not be available until a shipment from the US arrives around Dec. 17. The agency disclosed that it allowed Mylan to supply a batch of EpiPen Jr that did not pass quality specifications following notice from Mylan of the shortage.
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