FDA clears Preceptis Medical's in-office ear tube placement for kids - MassDevice

Preceptis Medical Hummingbird TTS ear tubes pediatricPreceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in an ENT surgeon’s office.

Officials at Maple Grove, Minn.–based Preceptis say the Hummingbird system significantly reduces trauma and procedure time for ear tube placement in young children. Kids receiving the ear tubes don’t need general anesthesia, and they don’t need to be in an operating room.

“Our office clinical study in over 200 children 6- to 24-months-old showed a 99% success rate in the office and a total procedure time of 5 minutes. This clearance will allow parents an option to have their child’s ear tubes placed without the need for general anesthesia or an operating room, while significantly reducing their costs,” Preceptis Medical CEO Steve Anderson said in a LinkedIn post.

Anderson in a company news release described the 510(k) clearance as an important milestone.

Dr. Shelagh Cofer, an otolaryngologist at Mayo Clinic and principal investigator for the Hummingbird, thinks the system represents a major advancement. “The benefits of the option of office ear tubes are huge in terms of convenience for patients and caregivers, reduction of risk and exposure to general anesthetic, and potential cost savings as well.”

Preceptis Medical plans a pilot commercial launch in select markets in the second half of 2020.

RSS From Medical Design & Outsourcing

  • 5 medtech companies win coveted Tekne awards
    Five medtech companies recently won some of the top technology awards in the state of Minnesota, known as one of three major medical device hubs in the U.S. The companies competed for the Minnesota Technology Association annual Tekne Awards, which included categories ranging from artificial intelligence and machine learning to “technology for good.” “The Tekne… […]
  • Spectrum Plastics acquires PeelMaster Medical
    Spectrum Plastics Group announced that it has closed on the acquisition of PeelMaster Medical Packaging. Based in Niles, Ill., PeelMaster is a full-service converter of sterile flexible packaging to the medical device market. Founded in 1989, PeelMaster produces pouches, header bags and die-cut lids for medical applications. PeelMaster has been an ized converter of DuPont… […]
  • The best places to work for medtech sales reps
    Teleflex (NYSE:TFX), ConMed (NSDQ:CNMD) and orthopedic fixation company Acumed top the list of best places to work in medtech sales in the coming year, according to a MedReps.com survey of medical sales representatives. The 10th annual MedReps survey polled more than 2,000 medical sales professionals in October 2020 to get a better understanding of what employees look for… […]
  • Researchers tout probes for validating rapid COVID-19 tests
    Nanoengineers at the University of California San Diego have developed probes that they say could make validating rapid, point-of-care COVID-19 tests easier. The probes, called “positive controls,” are made from virus-like particles and are stable and easy to manufacture, according to a news release. The researchers at UCSD believe the positive controls can improve the… […]
  • How ResMed is advancing sleep and respiratory care
    The COVID-19 pandemic’s propulsion of widespread telehealth adoption has ResMed (NYSE:RMD) eyeing remote technologies for the next phase of its sleep and respiratory businesses. The president of that business for the San Diego-based company, Jim Hollingshead, told Medical Design & Outsourcing in a recent interview that the future lies with remote care and digital health offerings. “Right… […]
  • Stricter Documentation Requirements Pose New Challenges for Medical Device Manufacturers
    By Maurizio Lauria, Brand Manager, STEUTE Meditech Inc. New European guidelines and standards have greatly increased the testing and documentation required in order to introduce a new medical device, making the process even more complex and time-consuming for medical device manufacturers. Additionally, these standards apply not only to the device itself but the user interface,… […]
  • 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… […]
  • FDA allows dry heat treatment for single-user mask reuse
    The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not izing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s,… […]
  • Mass General researchers tout low-cost, portable brain imaging scanner
    Researchers at Massachusetts General Hospital are touting a low-cost, portable “head only” MRI scanner that could be used in multiple settings. As opposed to standard costly, immobile MRI scanners that require special infrastructure, the MGH researchers developed a low-cost, compact, portable and low-power scanner that could be mounted in an ambulance, wheeled into a patient’s… […]
  • HHS confirms involvement in presidential transition process
    U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential… […]
  • Swiss scientists make ‘micromachines’ for self-deploying stents and more
    Researchers in Zurich reported today that they have invented a manufacturing technique to build “micromachines” out of metal and plastic in which these two materials are interlocked as closely as links in a chain. These robots are so tiny that they can maneuver through blood vessels and deliver medications to certain points in the body… […]