FDA probes Intuitive Surgical on complication rates

Intuitive Surgical

The FDA is looking into complication rates for surgeries using Intuitive Surgical‘s (NSDQ:ISRG) da Vinci surgical robot, sending a survey to doctors who use the device.

New of the probe, first reported by Bloomberg, sent ISRG shares down 11.1% to $509.89 apiece on Wall Street yesterday. The stock recovered some of that today, hitting $547.62 in pre-market trading and reaching $552.47 each as of about 11 this morning.

The FDA asked surgeons at "key hospitals" to detail any complications they’ve seen with the da Vinci robot, according to a copy of the survey obtained by the news service. The survey also asked about procedures the device might be good for and those it might not be ideal for and about the training they received on using the device.

The news comes on the heels of a study questioning the cost-effectiveness of hysterectomies using the da Vinci.

An FDA spokeswoman told Bloomberg that the agency is trying to get an accurate read on the increase in incident reports it’s seeing.

"It is difficult to know why the reports have increased," Synim Rivers told the news site.

Analysts on Wall Street downplayed the development, affirming or raising their ratings on Intuitive. Cantor Fitzgerald’s Jeremy Feffer raised his rating from "hold" to "buy" today and raised his price target to $575 per share.

"While we certainly understand investor concern over the words ‘FDA probe,’ we see limited risk of this investigation materializing into significant punitive measures against the company," the Cantor analysts wrote. "The main criticisms of [the da Vinci robot] have not been safety-related, but have rather focused on its higher cost relative to outcomes that are equivalent to laparoscopic. But because da Vinci is typically used in more complex cases, the more appropriate comparison is with open surgeries, against which da Vinci has superior outcomes and much lower complication rates."

Intuitive’s chief medical advisor, Myriam Curet, said the robots are "extremely safe," Bloomberg reported.

"There is a lot of redundancy in the system to make it as safe as possible," Curet said, noting that the rates of death and injury are "extraordinarily small."

RSS From Medical Design & Outsourcing

  • 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 […]
  • GDS security protects medical devices from hackers
    As data breaches become more commonplace with serious consequences to personal, corporate and national security, it is clear that there is no shortage of accomplished and effective hackers ready to steal data and trade it on the open market. Global Data Sentinel (GDS) has the ability to provide retroactive security to remove access to email […]
  • BRAEBON and SomnoMed combine products to combat sleep apnea
    BRAEBON Medical Corporation announces that the DentiTrac oral appliance compliance system has passed a regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent oral device. BRAEBON congratulates SomnoMed for being the first company to achieve this milestone. “We are pleased DentiTrac is launching in the US market. Accurate oral appliance […]
  • For advanced shielded plastic connector solution, ODU delivers with latest product
    ODU, a company which designs and manufactures connector solutions and cable assemblies, is announcing ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions, to the US market. ODU MEDI-SNAP EMC is the latest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable […]
  • LifeVac steps towards availability on European markets
    On June 16, 2015, LifeVac Europe received confirmation from the UK Ministry of Health that LifeVac is now registered in the Medicines and Healthcare products Regulatory Agency public access data base. This is the final step towards acquiring the CE mark and making LifeVac available to the entire European market. “We are very excited to […]
  • A few ideas for improving productivity in medical processes
    Drive-based vibration and slosh control can help improve throughput in machines that assemble medical devices and products. Bipin Sen • Ed Lasch Bosch Rexroth Corporation www.boschrexroth-us.com Simply increasing the speed of a system that assembles medical devices, or packages medical products, seems like an easy way to boost throughput – until unwanted vibration (either induced […]
  • ODU announces MEDI-SNAP EMC for next generation medical applications
    ODU, announced ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions to the US market. ODU MEDI-SNAP EMC is the newest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable EMI protection at the same time. ODU MEDI-SNAP EMC is available in […]
  • Evaluating the risk of device misconnections: Designing for medical devices with ISO 80369 in mind
    Beginning in the 1990s, concerns grew regarding the proliferation of medical devices fitted with luer connectors and the reports of patient injuries and deaths arising from misconnections. Thus began a many-years process to develop new industry standards for the small-bore connectors used in medical device applications. The much-anticipated ISO 80369 series of standards for small-bore […]
  • Custom molded filter screen assemblies limit contamination and reduce product failure
    Molded screen insert assemblies from Minnesota Rubber and Plastics are custom designed for water, beverage, off-highway and transportation applications to filter out fluid contaminants and reduce product failure. A wide range of screen options are available in many materials for difficult filtration applications allowing use with different fluids. Filter assembly orifice sizes available range from .71 […]

Leave a Reply