Devices

Breakthrough for Limaca Endoscopic Ultrasound Biopsy

FDA has granted Limaca Medical a breakthrough device designation for its Precision-GI endoscopic ultrasound biopsy product. The device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract using the ultrasound visualization endoscope, according to the company. “Precision-GI is deployed and operated through an instrument channel in the endoscope to biopsy the tumor,” it says. “Suspect GI tumor locations include submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses, and within GI related organs such as the pancreas and liver.”

Limaca says that current endoscopic ultrasound fine needle biopsy devices require manual hand operation, where as Precision GI features a motorized, automated rotational cutting needle for tissue acquisition. “Precision GI is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more quickly and less traumatically than current products,” it says. “The automated design will provide for more efficient and effective diagnosis of GI cancers since it is designed to yield significantly superior quality and quantity of diagnostically relevant biopsy tissue.”

Initial data from Limaca’s comparative feasibility clinical study, which is ongoing, show that the device “obtained contiguous intact core tissue samples fully adequate for definitive diagnosis of pancreatic lesions,” according to the company. “The clean, non-contaminated tissue samples provided a high percentage of tumor content, with less blood and extraneous fluids.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome