Mela Sciences CEO: MelaFind rollout planned for early 2012

Dr. Joseph Gulfo, CEO of Mela Sciences (NSDQ:MELA), says the company plans to begin rolling out its MelaFind skin cancer detection system during the first quarter of 2012, after winning a hard-earned green-light from the FDA.

"I don’t think we’ll be ‘selling,’ in the classic sense of selling, for at least a year and a half," Gulfo told MassDevice. "Dermatologists want this system, so we don’t need to ‘sell’ it.

"Since this is a new technology, our challenge will be incorporating it into the doctor’s office," Gulfo said.

In what Mela Sciences is calling a "commercial development year," the company plans to place 200 MelaFind systems in the U.S. and 75 in Germany, working with doctors and patients to integrate the device into everyday care.

Sign up to get our free newsletters delivered straight to your inbox

The company doesn’t plan to seek insurance reimbursement until a few years down the line, Gulfo told us, adding that the systems cost $7,500 (including placement and training fees) and a patient use fee of $50.

When it comes time to distribute MelaFind on a large scale, the company will take the reins itself, instead of putting its flagship product in the hands of distributors.

The path to U.S. approval was a long one for Mela Sciences. More than two years, two panel reviews and one citizen’s petition after it signed on for a 6-month FDA review, the company won FDA clearance for the U.S. market yesterday.

It’s been a good season for the company, which also won CE Mark approval in the European Union for MelaFind in September.

The FDA green light marks an end to the years-long plight that made Mela Sciences a poster child for charges of unpredictability at the FDA, culminating in a Progressive Policy Institute report, "Is the FDA Strangling Innovation?"

In June, Gulfo told MassDevice that the company was an unintended victim of the push for reforms at the FDA’s Center for Devices & Radiological Health.

RSS From Medical Design & Outsourcing

  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]
  • Cosasco’s wireless communications protocol makes electrically hazardous areas safer
    Cosasco has expanded the functionality of its CWT-9020 wireless water system corrosion monitor for electrically hazardous areas by offering ISA100 Wireless communications protocol. Along with WirelessHART 7, the new protocol option allows the transmitter to integrate with an even wider range of existing wireless systems. ISA100 Wireless supports more wireless devices and provides an effective […]
  • Vicon captures a new development in motion capture (mocap)
    Vicon announced the launch of its new flagship camera platform, the Vicon Vantage. Drawing on over 30 years’ of motion capture (mocap) experience, the Vantage platform combines innovative technology with accessible design to open up motion capture to a broader audience. Vicon is a motion capture technology specialist company for science and life industries. Advances in […]
  • Satel’s latest product sets a new milestone in radio manufacturing
    The new Satelline TR4, from the Finnish manufacturer of radio data transmission systems, Satel sets a new milestone. The compact UHF transceiver with transmitting power of 1,000 mW is compatible with the protocols of Pacific Crest, Trimble and Satel. The type certifications in all important regions of the world make the TR4 ideal for integration […]
  • SCHURTER announces retirement of founder and management changes
    SCHURTER announced the retirement of founder Bruno H. Schurter on June 29, 2015. The company, founded in 1982 in Petaluma, California, will change management effective July 1, 2015. Bruno H. Schurter, president and CEO will retire after 33 years of heading up the privately held company, which is a subsidiary of SCHURTER Holding AG, founded in […]
  • Silicone: Expanding the horizon for modern medical devices
    Editor’s note: This article comes from Albright Technologies a manufacturer of custom silicone prototypes and provides volume production for medical, pharmaceutical, industrial, and other applications. Silicone materials have been around for more than 70 years. Beginning in the 1960s, silicones have played an important and evolving part in products designed for the medical field. Since that time, […]
  • DeNovo Sciences appoints a molecular diagnostics veteran as new CSO
    DeNovo Sciences, a producer of  liquid biopsy products, announced the appointment of Dr. Yixin Wang as Chief Scientific Officer (CSO). Dr. Wang is a veteran in molecular diagnostics where he has played significant R&D roles at large, multi-national companies including Parke-Davis/Pfizer, Veridex/Johnson & Johnson and Ventana/Roche. He will lead strategic initiatives for clinical development of DeNovo’s […]
  • Albright Technologies expands their silicone offerings
    Albright Technologies, a rapid silicone prototyper, has added silicone injection molding tooling and services to its product lineup. Liquid silicone injection molding became a suitable product offering as Albright expanded its offerings to better serve the silicone molding market. While silicone prototypes are commonly manufactured with low volumes in mind; injection molded liquid silicone rubber parts are […]
  • Applied Silver launches SilvaClean, silver treatment for textiles
    Applied Silver, Inc, is launching SilvaClean, a state-of-the-art silver treatment for textiles, at the Association for Professionals in Infection Control and Epidemiology’s (APIC) forty-second Annual Conference taking place at the Music City Center in Nashville, from June 27 through June 29. Hospitals have invested significantly in reducing the potential of infection through products and processes designed […]
  • Two-Component technology for improved quality of life
    In the field of injection molding and mold making, toolcraft covers all processes within the added value chain–from the design and selection of materials through to the creation of finished and qualified products. Complete solutions offered include injection molding for parts in the small and extremely small component areas, e.g. for medical technology. Utilizing two-component […]

Comments

  1. says

    I simply want to tell you that I am just beginner to blogging and site-building and really loved your web page. Probably I’m going to bookmark your blog . You definitely have great stories. With thanks for revealing your web site.

Trackbacks

  1. Hi, how are you?

    Apakah agan wati membutuhkan obat herbal de Nature Indonesia silahkan bisa hubungi customer service kami secara langsung via SMS ataupun Telepon. Kami selalu online 24 jam untuk melayani pemesanan produk herbal de Nature.

Leave a Reply