Acronyms, abbreviations and definitions of medtech terms, devices and companies
Medtech’s a complicated business, with its own industry abbreviations, acronyms and terms. Cut through the jargon with our constantly evolving glossary — and please suggest additions by emailing Managing Editor Jim Hammerand.3D printing: A type of additive manufacturing used to make patient-specific anatomical models, device prototypes and finished medical devices.
3TG: This is an abbreviation for tantalum, tin, tungsten and gold, which are some of the most commonly used conflict minerals in medical device manufacturing.
510(k): FDA clearance under Section 510(k) of the Food, Drug and Cosmetic Act authorizes a company to sell a Class I, II, or III medical device based on substantially equivalent predicate devices
AbbVie: This Abbott pharma spinoff gets its name from its former parent company — one of the world’s largest medical device companies — and “vie,” which Abbott said references the Latin root “vi” meaning “life.
ADA: The American Diabetes Association’s annual scientific sessions meeting is referred to as ADA.
AdvaMed: The Advanced Medical Technology Association, an organization that represents medical device makers
AFib: Atrial fibrillation is an irregular heart rhythm (arrhythmia) with a rapid heartbeat (tachycardia) that may be temporary or permanent. A variety of devices monitor, detect, diagnose and treat AFib, which is associated with cardiac complications such as heart failure and stroke.
AI: Artificial intelligence in medtech is exploding as device developers — including developers of algorithms and software-as-a-medical-device — find new or improved methods for diagnosis, patient monitoring, procedures and more efficient workflows.
AM: Additive manufacturing includes 3D printing and other processes that build medical devices or components layer by layer, most notably for prototyping, anatomical models and orthopedic implants.
Association of Medical Device Reprocessors: The AMDR represents organizations engaged in commercial reprocessing and remanufacturing of medical devices for re-use.
AVEIR: Abbot’s first-of-its-kind leadless pacemaker system for dual-chamber pacing, AVEIR, is an acronym: AV for atrial and ventricular, E for extended longevity, I for the “i2i” implant-to-implant communication system, and R for retrievable.
BD: Becton, Dickinson and Co. is one of the world’s largest medical device manufacturers.
BCI: Brain-computer interface systems monitor and collect brain signals (usually with an electrode brain implant) to relay commands for patients who have lost neuromuscular functions.
CAD: Coronary artery disease
CAPA: Corrective and preventive action
CCTGA: Congenitally corrected transposition of the great arteries
CDMO: Contract development and manufacturing organization, a third-party outsourcing partner that designs and makes medical devices or components for medtech developers and OEMs
CD: Chlorine dioxide (ClO₂) is a gas used to sterilize medical devices.
CDRH: The FDA Center for Devices and Radiological Health reviews medical devices and radiation-emitting products.
CGM: Continuous glucose monitor, used for diabetes
CHD: Congenital heart disease
CHIRP: The Canary Health Implanted Reporting Processor is an ortho sensor implant developed by Canary Medical for Zimmer Biomet’s Persona IQ Smart Knee.
Class I, II and III: The FDA uses three class levels to categorize the risk level of devices and recall. However, while a Class I recall is the most dangerous and a Class III recall the least dangerous, a Class I device is considered the lowest risk for patient health while Class III devices pose the greatest risk and are subject to the most regulatory oversight.
CLTI: Chronic limb-threatening ischemia is a severe form of peripheral artery disease (PAD) where patients lose blood flow below their knee, potentially requiring amputation. In 2023, the FDA approved LimFlow Medical’s first-of-its-kind transcatheter arterialization of deep veins (TADV) system as the last resort to avoid amputation.
CMF: Cranio-maxillofacial (or craniomaxillofacial) procedures and products apply to the craniofacial structure (bones and soft tissue of the skull and face) and the maxillofacial structure (including the face, jaw and mouth).
CMO: Contract manufacturing organization, a third-party outsourcing partner that makes components or devices for medtech developers and OEMs. CMO is also an abbreviation for two executive titles in a medical device company’s management: chief medical officer and chief marketing officer.
CNC: Computer numerical control machining uses software to operate factory tooling and equipment.
Combination products/devices: These medical products use a combination of drugs, devices, and/or biological products for therapies and diagnostics. Examples include pre-filled drug syringes, antibiotic-coated implants, inhalers and microneedle patches.
Complaint files: The FDA requires medical device manufacturers to retain files of all complaints and establish and maintain procedures for receiving, reviewing, and evaluating complaints.
CRO: Contract research organization, a third party that provides medical device developers and manufacturers with outsourced research services
CT: Computed tomography is a computerized imaging procedure that aims a narrow beam of X-rays at a patient and rotates around the body to produce cross-sectional visualizations of bones, blood vessels and soft tissue.
CVC: Central venous catheter
De novo: De novo classification from the FDA allows a medical device company to market a novel Class I or II device.
DHF: A design history file is a compilation of records describing the design history of a finished device. The FDA requires medical device manufacturers maintain this information.
DHR: A device history record is a compilation of records containing the production history of a finished device. The FDA requires medical device manufacturers maintain this information.
DMR: A device master record is a compilation of records containing the procedures and specifications for a finished device. The FDA requires medical device manufacturers maintain this information.
DV5: The da Vinci 5 is Intuitive’s fifth-generation surgical robotics platform.
ECG/EKG: Electrocardiogram, a device for monitoring and recording heart signals
EEG: An electroencephalogram measures brain activity using electrodes
EFS: An early feasibility study is described by the FDA as “a limited clinical investigation of a device early in development” to evaluate and improve device design for more efficient product development.
Electron-beam sterilization: Also called e-beam sterilization, this is one of the fastest-growing methods of sterilizing medical devices.
Embecta: The name of this BD diabetes care business spinoff includes “em” for empathy for those living with diabetes, and “bect” for former parent company Becton, Dickinson & Co.
EP: Electrophysiology is the study of electrical signals in the heart, allowing the use of medical devices to diagnose, map and treat irregularities.
ESG: This abbreviation can stand for environmental, social and governance (a corporate function focused on sustainability, ethics and decision-making) or endoscopic sleeve gastroplasty (a surgical procedure to reduce the size of a patient’s stomach to treat obesity).
EtO: Ethylene oxide is a gas used to sterilize around half of all medical devices.
FAERS: The FDA Adverse Event Reporting System is a database of adverse event reports, medication error reports and product quality complaints submitted to FDA.
FDA: The U.S. Food & Drug Administration
FHE: Flexible hybrid electronics combine the additive manufacturing approaches for electronics fabrication with the performance of thinned semiconductor devices and discrete components.
FMEA: Failure Mode and Effect Analysis proactively identifies and addresses potential problems with a medical device before they arise to mitigate those failures.
GLP-1: Glucagon-like peptide-1 agonists are a class of drugs for type 2 diabetes patients that can also cause weight loss. These drugs could affect demand for medical devices used for diabetes, baratric surgeries, joint replacements and other procedures.
Harmonization by Doing: HBD is a collaboration between the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to expedite medical device approvals in both countries.
Human factors: This element of medical device design and engineering considers how physicians, patients, caregivers and other users interact with a particular product to ensure it works safely and intuitively.
HUD: Humanitarian use device designation is an FDA approval pathway for medical devices that may help people with rare diseases or conditions, defined as those affecting no more than 8,000 people in the U.S. per year.
IDE: Investigational device exemption from the FDA permits the use of an investigational device in a clinical study to collect data on the product’s safety and effectiveness.
IFU: Instructions for use tell a patient or caregiver how to use a device, including set-up, operation, cleaning, troubleshooting and storage.
ISO: The International Organization for Standardization gets its abbreviated name from “isos,” the Greek word for equal.
IVD: In vitro diagnostic
IVDR: The European Commission’s In Vitro Diagnostics Regulation
IVL: Intravascular lithotripsy is a way to treat arterial calcification with sonic pressure waves.
J&J: Johnson & Johnson is the world’s second-largest medical device company through its Johnson & Johnson MedTech unit, formerly Johnson & Johnson Medical Devices.
MDUFA: Medical Device User Fee Amendments allow the FDA to collect fees from medical device manufacturers to fund device review and regulation.
Medtech: Medical technology
Medical Device Regulation: The European Union’s Medical Device Regulation is commonly abbreviated as MDR.
Medical Device Reporting: MDR is one of the FDA’s tools to monitor medical device performance and safety issues.
Medtronic: The world’s largest medical device company by revenue was founded in 1949 as a medical electronics repair business.
MEMS: micro-electromechanical systems
MIRA: Virtual Incision’s surgical robotics system, MIRA, stands for Miniaturized In Vivo Robotic Assistant.
MRSA: Methicillin-resistant Staphylococcus aureus
Nitinol: A nickel-titanium alloy (sometimes referred to as NiTi) with shape memory properties that make it useful in many medtech applications.
OEM: Original equipment manufacturer is an entity such as Medtronic that makes its own components or devices, versus a CMO that manufactures those products on behalf of an OEM.
PAD: Peripheral artery disease (which includes CLTI)
PAH: Pulmonary arterial hypertension
PEEK: Polyetheretherketone is a thermoplastic polymer used in orthopedic and cardiovascular implants due to its biocompatibility and resistance to heat and chemicals.
PFA: Pulsed field ablation uses nonthermal energy to treat atrial fibrillation
PGA, PLGA and PLLA: These biodegradable, biocompatible polymers —polyglycolic acid, poly(lactic-co-glycolic acid) and poly-L-lactic acid —are used for absorbable medical devices such as sutures, stents, bone screws and fillers.
PICC: Peripherally inserted central catheter
PMA: Premarket approval is the FDA’s review process for Class III medical devices, which are those that support or sustain life, are substantially important in preventing health impairment or pose the greatest risk of serious injury or death.
PMDA: The Pharmaceuticals and Medical Devices Agency is Japan’s version of the FDA.
Postmarket surveillance: Defined by the FDA as “the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.”
PVC: Polyvinyl chloride
QMS/QS/QSR: A medical device manufacturer’s quality management system (QMS), quality system (QS) and quality system record (QSR) are all regulated by the FDA, which requires all medical device manufacturers to maintain a QSR.
RF: Radiofrequency energy can be used for minimally invasive catheter treatments such as renal denervation for hypertension and ablation for atrial fibrillation, cancer and other conditions.
RDN: Renal denervation is a treatment for hypertension that applies electricity to deactivate nerves in the arteries that carry blood to the kidneys. Renal denervation systems won FDA approval for the first time in 2023.
R&D: Research and development (see the top medtech R&D spenders here)
Reprocessing: A process for cleaning and disinfecting or sterilizing medical devices for re-use, including certain single-use devices under FDA standards.
ROSA: The name of Zimmer Biomet’s ROSA surgical robotics platform stands for Robotic Surgical Assistant.
RTA: Refuse to Accept is a designation given by the FDA to an unsatisfactory regulatory submission for a device that for one or more reasons can’t be approved, cleared or authorized for marketing. An RTA is not necessarily the end for a product’s chances if a device developer is willing and able to address the deficiencies.
RWD: Real-world data is defined by FDA as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWD sources include electronic health records, medical claims, product or disease registries, and digital health technologies such as apps or smart sensors.
RWE: Real-world evidence is clinical evidence of a device’s safety and/or effectiveness collected derived from analysis of real-world data (RWD).
SaMD: Software-as-a-medical-device is software with a medical purpose that’s not part of a physical medical device.
SCD: The Selective Cytopheretic Device is made by SeaStar Medical for extracorporeal therapy to treat hyperinflammation.
SCG: Seismocardiogram, a device for monitoring and recording heart vibrations
SLA: Stereolithography is a type of 3D printing for high-accuracy, isotropic, and watertight prototypes and end-use parts with fine features and smooth surface finish.
SLS: Selective laser sintering is a type of 3D printing that uses lasers to build components or devices layer by layer out of powdered metal such as titanium.
Solventum: The new name for 3M’s spun-off healthcare business (formerly 3M Health Care) is a combination of the words “solving” and “momentum.”
TCET: Transitional Coverage for Emerging Technologies, a new pathway proposal for Medicare coverage of breakthrough devices
TCT: The Transcatheter Cardiovascular Therapeutics conference is the annual meeting of the Cardiovascular Research Foundation (CRF) for interventional cardiovascular medicine.
TIF: Tissue interstitial fluid
TADV: Transcatheter arterialization of deep veins restores blood flow to an ischemic foot by rerouting blood from a blocked artery to a vein.
TAVR: Transcatheter aortic valve replacement is a minimally invasive procedure to replace a heart valve with an implant delivered by catheter rather than open-heart surgery.
TPE: Thermoplastic elastomer
UDI: Unique device identifier, required by the FDA on medical devices to track each individual unit from manufacturing through distribution and use
VHP: Vaporized hydrogen peroxide is a method for sterilizing medical devices.
VRE: Vancomycin-resistant enterococci
ZB: Zimmer Biomet is one of the world’s largest medical device companies and the third-largest orthopedics manufacturer.
ZimVie: The name of Zimmer Biomet’s spine and dental businesses spinoff is a combination of “Zim” from its former parent company and “Vie,” the French word for “life.” ZimVie is one of the world’s largest medical device manufacturers.
This post was originally published in July 2023 and was most recently updated in March 2024.