Cancer diagnostics firm Neoprobe Corp. (NYSE Amex:NEOP) pressed past the controversy surrounding its Lymphoseek radiopharmaceutical and submitted a new drug application for FDA review.
The Dublin, Ohio-based company hopes to win clearance for Lymphoseek for use in intraoperative lymphatic mapping, a surgical procedure that identifies and biopsies lymph nodes for traces of cancer.
Neoprobe has weathered a storm of criticism, including a citizen’s petition filed by hedge fund MSMB Capital Management asking the FDA to block the new drug application the grounds that the drug’s pivotal trials suffered from vital mistakes, allegations that Neoprobe has officially rebutted.
In its formal response, Neoprobe called the citizen’s petition "baseless and replete with factual and regulatory misstatements, served under a cloak of legitimacy," and called MSMB a "short-seller who could potentially benefit financially from a decline in Neoprobe’s stock price."
"In over 500 subjects receiving Lymphoseek to date," Neoprobe wrote it a recent press release, "no drug-related serious adverse events or clinically significant drug-related adverse events have been reported."
Tustin, Calif.-based Toshiba Medical Systems Corp. touted FDA clearance for its "patient friendly" Vantage Titan 3T open bore MR designed to improve patient compliance and comfort without sacrificing advanced radiology capability. The device boasts noise reduction technology, a wide and open bore, feet-first imaging and proprietary contrast-free techniques.
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Natick, Mass.-based Boston Scientific Corp. (NYSE:BSX) announced that it won Canadian approval for an expanded indication on its WallFlex stent, which may now be used to treat benign biliary strictures.
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GE Healthcare announced FDA clearance for its Optima CT660 device, a next-generation compact computer tomography system for a variety of clinical settings, including cardiac, neurological, emergency room and routine CT.
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Lyon, France-based EDAP TMS SA (NSDQ:EDAP) won FDA 510(k) clearance for its Sonolith i-move lithotripter, a device that uses shock waves to pulverize kidney stones. The Sonolith device includes an infrared stereo-vision system for real-time, three-dimensional ultrasound location of stones.
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Atlanta, Ga.-based MedShape Solutions Inc. announced FDA 510(k) clearance for its DynaNail intramedullary ankle fusion nail, which uses shape memory alloy technology to actively adapt to changes such as local bone resorption.
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Mountain View, Calif.-based IntraPace Inc. won CE Mark approval in the European Union for a wireless monitoring feature on its abiliti weight-loss device, which, when implanted in a patient, detects eating and drinking habits and sends low-level electrical impulses to the stomach to give a feeling of fullness. The new feature allows patients to wirelessly access data on their eating and drinking habits.
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Arden Hills, Minn.-based IntriCon Corp, (NSDQ:IIN) announced FDA 510(k) clearance for its Centauri cardiac diagnostic monitor with wireless transmission of critical patient data.
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Minneapolis, Minn.-based BridgePoint Medical Inc. enrolled their first patient into a study of the safety and effectiveness of the company’s devices in chronically occluded arteries in the legs.
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Redwood City, Calif.-based Relievant Medsystems Inc. announced that it received FDA approval to begin clinical trials of its Intracept treatment for lower back pain. Intracept uses radiofrequency energy delivered through a small access tube in the lower back to deaden the basivertebral nerve, which is believed to be a big contributor to chronic lower back pain.
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