MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Neoprobe presses past controversy, submits Lymphoseek NDA| Regulatory Roundup

Neoprobe presses past controversy, submits Lymphoseek NDA| Regulatory Roundup

By

Neoprobe

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."

Regulatory Roundup
  • Toshiba lands FDA clearance for 3T MR
    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.

    Read more

  • Boston Scientific wins expanded indication of WallFlex stent from Canadian regulators
    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.
    Read more

  • GE lands FDA clearance for Optima compact CT system
    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.

    Read more

  • EDAP wins 510(k) clearance for compact kidney stone pulverizer
    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.

    Read more

  • MedShape Solutions gets FDA nod for ankle fusion device
    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.

    Read more

  • IntraPace gets European approval for weight-loss device wireless monitoring
    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.

    Read more

  • IntriCon lands 510(k) clearance for diagnostic monitor
    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.

    Read more

  • BridgePoint Medical lands IDE approval for peripheral chronic total occlusion study
    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.
    Read more

  • Relievant Medsystems gets FDA approval to begin pivotal study of lower back pain
    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.
    Read more

    • In case you missed it

    RSS From Medical Design & Outsourcing

    • Versapor® RC Membranes: The next generation of venting materials
      As the world leader in the design and production of membranes, filtration devices, and separation systems, Pall Corporation supplies products to nearly every industry in the world. Founded in 1946, Pall Corporation has set the standard for filtration solutions for 75 years and counting. Our customers have relied on us for their most sophisticated applications… […]
    • Tips to help bring your medical device from mind to market
      By Bret Ludwig, Ph.D. Senior Product Development Specialist, 3M Medical Materials & Technologies Great medical devices start with an idea—a spark. And from there, it might move to the back of a napkin or a notepad. But as development continues, the process can get trickier and more complex. In fact, turning an idea into a… […]
    • Salt baths increase stability in the medical device tempering process
      Calibration baths, like salt baths, were originally for calibrating temperature assets. But there’s another use for them: manufacturing Nitinol medical devices. Travis Porter, Fluke Calibration Nitinol is a nickel-titanium alloy that exhibits both thermal shape memory behavior and super-elasticity. It’s a great metal to use in medical devices because it’s possible to set the wire… […]
    • Traco Power announces new TMW 24 and TMW 36 series
      Traco Power (San Jose, Calif.) recently announced the company’s new TMW series of 24- and 36-W power supplies. The new power supplies are IP68 rated and fully encapsulated — with flexible options for PCB or chassis mounting for the medical and industrial markets. The TMW Series were also designed for flush box-mounting to support IoT… […]
    • Protolabs reports mixed-bag results for Q2
      Protolabs (NYSE: PRLB) posted second-quarter earnings today that missed the consensus forecast on Wall Street, though the company beat on revenue. The Maple Plain, Minn–based digital manufacturing outsourcer — which serves medtech and a host of other industries — reported profits of $12.9 million, or 47¢ per share, on sales of $123.0 million for the… […]
    • Integer beats The Street in Q2, boosts sales outlook
      Integer Holdings (NYSE:ITGR) posted second-quarter results today that beat the consensus forecast on Wall Street — boosting its 2021 sales outlook amid continued recovery from the COVID-19 pandemic. The Plano, Texas–based medical device contract manufacturing giant reported profits of $29.4 million, or 89¢ per share, on sales of $312.0 million for the three months ended… […]
    • Keep the end in mind when choosing a medtech partner
      There are five general categories of medtech vendor partners. If the end is apparent in the beginning, the correct type of partner will be clearer. Jim Reed, Minnetronix Medical Stephen Covey gave the business world this mantra in one of his bestsellers: “Start with the end in mind.” Whether they didn’t read the book or… […]
    • Orthofix launches Fiberfuse Strip bone graft
      Orthofix (NSDQ:OFIX) today announced that it has launched its FiberFuse Strip bone graft in the U.S. Lewisville, Texas–based Orthofix designed the FiberFuse Strip to be a preformed bone-graft strip for posterior cervical, posterior lumbar and degenerative spinal procedures. FiberFuse Strip is 100% bone and has a unique mixture of mineralized cancellous and demineralized cortical bone with… […]
    • Thermo Fisher Scientific beats The Street in Q2 results
      Thermo Fisher Scientific (NYSE:TMO) today posted second-quarter results that beat the overall consensus on Wall Street. The Waltham, Mass.–based company reported profits of $1.8 billion, or $4.61 per share, on sales of $9.3 billion for the three months ended July 1, 2021, for a bottom-line gain of 58.1% on sales growth of 34.1% compared with… […]
    • Choosing the Right Rubber Material and Process for Your Medical Parts
      When it’s time to design and develop a new medical device that calls for an elastomer component, there are a number of material options and manufacturing processes to consider. The long list of material properties impacting performance includes your prospective polymer’s end-use environment, chemical compatibility, hardness, compression set, tensile properties and manufacturability — to name… […]
    • 3M’s healthcare segment registers growth in Street-beating Q2
      3M (NYSE:MMM) reported second-quarter results that beat the consensus forecast — with the company’s healthcare segment showing especially robust growth. The St. Paul, Minn.–based company posted profits of $1.5 billion, or $2.59 per share, on sales of $9 billion for the three months ended June 30, 2021, for a 16.7% bottom-line gain on sales growth of… […]

    Leave a Reply