Oxford Biodynamics plc is launching its clinical assay Episwitch CIRT in the U.S. following clinical validation that demonstrated the 3D genomic eight biomarker panel can predict a cancer patient’s response to immune checkpoint inhibitor (ICI) therapy at up to 93% sensitivity, 82% specificity and 85% accuracy. ICIs are currently used against more than 15 types of cancer but less than one in three patients show any benefit from the treatment. Read More
With a round of conference presentations and a new marketing program launched this week, Sight Sciences Inc. kicked off a focused effort to increase awareness of its Omni surgical system’s FDA clearance for glaucoma procedures performed independently of cataract surgery. The coordinated push aims to further boost revenues, which saw an estimated 65% increase compared to 2020 and 12% increase quarter-on-quarter, based on preliminary fourth quarter and fiscal year 2021 results. Read More
PERTH, Australia – Nearly three-fourths of medical device stakeholders supported introducing mandatory reporting of medical device-related adverse events by health care facilities in Australia, but many raised concerns about data duplication and integrity. Read More
A needle-free injection system for patients with diabetes developed by Nugen Medical Devices Inc. has been approved for use in 40 countries but until now has yet to crack the North American market. Nugen said it is now gearing up for FDA and Mexican approval of the Nugen MD needle-free injector following Health Canada’s approval of the system less than a month after the Toronto med tech went public in late 2021. Read More
The FDA reported that the recall of the Arrow-Trerotola percutaneous thrombolytic device is a class I recall due to the risk of tip damage during use. This hazard could result in detachment of the tip from the device basket, which could damage or block vessels, a potentially lethal hazard for the patient. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, Echolight Medical, Motus GI, Terumo. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Seegene. Read More
