FDA slaps Bioptigen with warning over marketing claims

Bioptigen

Medical imaging technology company Bioptigen received a warning from the Food & Drug Administration alleging that the company is marketing its eye imaging scanner without proper approvals.

The Research Triangle Park, N.C.-based company makes a medical device that allows for imaging of the inner areas of the eye. The company has marketed the product for research as well as medical applications.

The FDA’s Feb. 9 letter raised a warning about Bioptigen’s hand-held imaging device. The company won 510(k) clearance in 2006 for a tabletop scanner for use in the “evaluation of ophthalmic tissue in routine clinical examinations as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.”

MedCity News logo

The hand-held imaging system represents a modified device design, and the company’s website and brochures claim that the hand-held system may be used for specific diagnostic purposes such as retinopathy of prematurity, pediatric retinoblastoma and shaken baby syndrome, according to the FDA. These changes are outside of the company’s 510(k) clearance, the watchdog agency wrote in the letter.

Bioptigen CEO Eric Buckland acknowledged the warning letter but he declined to answer questions.

“We are preparing a response,” he said. “I’d rather not talk about it until after we submit the response.”

Bioptigen was founded in 2004 based on spectral domain technology developed in the biomedical engineering department of Duke University’s Pratt School of Engineering>. Bioptigen licensed the technology from Case Western Reserve University (PDF), where Professor Joseph Izatt initially worked on the technology before leaving for a position at Duke University in 2001.

Bioptigen’s imaging systems use a technology called optical coherence tomography, or OCT. The company’s website describes OCT as analogous to ultrasound, using light waves instead of sound waves. The backscattered light is processed to develop a high-resolution image that can be used for analysis without physical contact with the subject. That makes the technology particularly helpful with non-cooperative patients, such as infants.

Bioptigen’s last round of financing was also its first, a 2006 series A round that brought Bioptigen $1.3 million from the Piedmont Angel Network of Greensboro, N.C., along with several individual investors.

RSS From Medical Design & Outsourcing

  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]
  • MasterControl’s CEO talks EQMS software and new partnerships
    MasterControl offers a quality and compliance software that helps device companies speed time to market and improve their bottom lines. Under Jon’s leadership, the company has blossomed into a market leader and has a unique corporate culture that fosters growth, excellence and quality. In this podcast, MasterControl’s CEO, Jon Beckstrand, will discuss electronic quality management […]
  • BIT Group launches white label IVD solutions
    BIT Group has launched a product line of customizable IVD white label instruments. During recent years, BIT has invested capital and resources developing customizable, ready-to-use IVD systems to address a growing demand. “The IVD market is challenging for our clients,” said Marius Balger, CEO at BIT. “OEM’s must adhere to a growing number of evolving IVD […]
  • Toshiba expands line-up of ARM Cortex-M-based microcontrollers
    Toshiba announced that it has enhanced its current “TX Family” of ARM core-based microcontrollers and started to develop three series of microcontrollers, “TXZ0 series,” “TXZ3 series” and “TXZ4 series,” as part of the “TXZTM Family.” The TXZTM Family is a new collection of flash microcontrollers that support low-power consumption and high-speed operation for IoT and M2M […]
  • Parker Hannifin consolidates, layoffs ahead
    Parker Hannifin plans to consolidate a number of internal divisions, close 2 facilities and expand its Mexican operations, according to an internally distributed letter from Andy Ross, Parker’s engineered materials group president. The company has confirmed the letter was authentic, but has not disclosed how many employees will be affected by the new plans or […]
  • 3-phase current transducer from PEM delivers all-in-one convenience
    The new RCTrms 3-ph current transducer from Power Electronic Measurements (PEM) delivers a convenient, safe and accurate solution for measuring current in three phases. It features a thin, clip-around, flexible sensor coil and provides accurate true rms measurement with 4-20 mA or 0-5 V output, enabling simple installation with PLC’s, SCADA systems or automation equipment. […]
  • Safety alert: Recall on two IV solutions from Baxter
    Baxter International announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital and user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to […]

Leave a Reply