Preceptis Medical is a medical device company based in Plymouth, Minnesota, specializing in pediatric tympanostomy tubes. The company's flagship product is the Hummingbird Tympanostomy Tube System, noted for being one of the only ear tubes that can be inserted without general anesthesia.
Preceptis was founded in 2011 as a startup. [1] In 2013, Preceptis won the grand prize at The Minnesota Cup, a competition that awards innovative business ideas. [2]
In 2020, it was granted FDA clearance for children 6 to 24 months of age. [3] In 2022, the FDA cleared the Hummingbird Tympanostomy Tube System to be used in children 6 months old and older. [4]
In 2024, the Centers for Medicare & Medicaid Services assigned a Healthcare Common Procedure Coding System (HCPCS) code to the Hummingbird TTS procedure. This coding supports the adoption of the Hummingbird system by providing clear reimbursement pathways for ENT specialists. [5]
The Hummingbird is notable for the lack of general anesthesia, [6] instead only requiring the eardrum to be numbed. [7]
Anesthesia or anaesthesia is a state of controlled, temporary loss of sensation or awareness that is induced for medical or veterinary purposes. It may include some or all of analgesia, paralysis, amnesia, and unconsciousness. An individual under the effects of anesthetic drugs is referred to as being anesthetized.
Tracheal intubation, usually simply referred to as intubation, is the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway or to serve as a conduit through which to administer certain drugs. It is frequently performed in critically injured, ill, or anesthetized patients to facilitate ventilation of the lungs, including mechanical ventilation, and to prevent the possibility of asphyxiation or airway obstruction.
Sedation is the reduction of irritability or agitation by administration of sedative drugs, generally to facilitate a medical procedure or diagnostic procedure. Examples of drugs which can be used for sedation include isoflurane, diethyl ether, propofol, etomidate, ketamine, pentobarbital, lorazepam and midazolam.
Otitis media is a group of inflammatory diseases of the middle ear. One of the two main types is acute otitis media (AOM), an infection of rapid onset that usually presents with ear pain. In young children this may result in pulling at the ear, increased crying, and poor sleep. Decreased eating and a fever may also be present.
In medicine, venipuncture or venepuncture is the process of obtaining intravenous access for the purpose of venous blood sampling or intravenous therapy. In healthcare, this procedure is performed by medical laboratory scientists, medical practitioners, some EMTs, paramedics, phlebotomists, dialysis technicians, and other nursing staff. In veterinary medicine, the procedure is performed by veterinarians and veterinary technicians.
Adenoidectomy is the surgical removal of the adenoid for reasons which include impaired breathing through the nose, chronic infections, or recurrent earaches. The effectiveness of removing the adenoids in children to improve recurrent nasal symptoms and/or nasal obstruction has not been well studied. The surgery is less commonly performed in adults in whom the adenoid is much smaller and less active than it is in children. It is most often done on an outpatient basis under general anesthesia. Post-operative pain is generally minimal and reduced by icy or cold foods. The procedure is often combined with tonsillectomy, for which the recovery time is an estimated 10–14 days, sometimes longer, mostly dependent on age.
Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia. BIS monitors are used to supplement Guedel's classification system for determining depth of anesthesia. Titrating anesthetic agents to a specific bispectral index during general anesthesia in adults allows the anesthetist to adjust the amount of anesthetic agent to the needs of the patient, possibly resulting in a more rapid emergence from anesthesia. Use of the BIS monitor could reduce the incidence of intraoperative awareness during anaesthesia. The exact details of the algorithm used to create the BIS index have not been disclosed by the company that developed it.
Massachusetts General Hospital is a teaching hospital located in the West End neighborhood of Boston, Massachusetts. It is the original and largest clinical education and research facility of Harvard Medical School/Harvard University, and houses the world's largest hospital-based research program with an annual research budget of more than $1.2 billion in 2021. It is the third-oldest general hospital in the United States with a patient capacity of 999 beds. Along with Brigham and Women's Hospital, Mass General is a founding member of Mass General Brigham, formerly known as Partners HealthCare, the largest healthcare provider in Massachusetts.
A myringotomy is a surgical procedure in which an incision is created in the eardrum to relieve pressure caused by excessive buildup of fluid, or to drain pus from the middle ear. A tympanostomy tube may be inserted through the eardrum to keep the middle ear aerated for a prolonged time and to prevent reaccumulation of fluid. Without the insertion of a tube, the incision usually heals spontaneously within two to three weeks. Depending on the type, the tube is either naturally extruded in 6 to 12 months or removed during a minor procedure.
Tympanoplasty is the surgical operation performed to reconstruct hearing mechanism of middle ear.
Intraosseous infusion (IO) is the process of injecting medication, fluids, or blood products directly into the bone marrow; this provides a non-collapsible entry point into the systemic venous system. The intraosseous infusion technique is used to provide fluids and medication when intravenous access is not available or not feasible. Intraosseous infusions allow for the administered medications and fluids to go directly into the vascular system. The IO route of fluid and medication administration is an alternative to the preferred intravascular route when the latter cannot be established promptly in emergent situations. Intraosseous infusions are used when people have compromised intravenous access and need immediate delivery of life-saving fluids and medications.
The Current Procedural Terminology (CPT) code set is a procedural code set developed by the American Medical Association (AMA). It is maintained by the CPT Editorial Panel. The CPT code set describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes. New editions are released each October, with CPT 2021 being in use since October 2021. It is available in both a standard edition and a professional edition.
Tympanostomy tube, also known as a grommet,myringotomy tube, or pressure equalizing tube, is a small tube inserted into the eardrum via a surgical procedure called myringotomy to keep the middle ear aerated for a prolonged period of time, typically to prevent accumulation of fluid in the middle ear.
Endometrial ablation is a surgical procedure that is used to remove (ablate) or destroy the endometrial lining of the uterus. The goal of the procedure is to decrease the amount of blood loss during menstrual periods. Endometrial ablation is most often employed in people with excessive menstrual bleeding, who do not wish to undergo a hysterectomy, following unsuccessful medical therapy.
Cochlear is a medical device company that designs, manufactures, and supplies the Nucleus cochlear implant, the Hybrid electro-acoustic implant and the Baha bone conduction implant.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
Jack Leon Paradise was a pediatrician, pediatric primary care researcher, and professor emeritus of pediatrics at University of Pittsburgh School of Medicine.
The Healthcare Common Procedure Coding System is a set of health care procedure codes based on the American Medical Association's Current Procedural Terminology (CPT).
Ida Pavlichenko is an Azerbaijani biomedical engineer and a Technology Development Fellow at the Harvard University Wyss Institute for Biologically Inspired Engineering. Pavlichenko is the co-founder and chief executive officer of PionEar Technologies, a medical device company that develops intelligent technologies for treating ear and hearing disorders. The tympanostomy technology she invented for treated recurrent ear infections has been nationally recognized for its innovative design which addresses many of the limitations of current ear tubes.
Anterior vertebral body tethering (AVBT) is a relatively new surgery for the treatment of scoliosis in pediatric patients. Left untreated, severe scoliosis can worsen and eventually affect a person's lungs and heart.