Tools commonly used in the Pacemakers-Cardiac (Manufacturing) industry for day-to-day tasks and operations.

• Microelectronics assembly equipment
• Soldering equipment
• Laser welding equipment
• Cleanroom facilities
• Testing and calibration equipment
• Quality control equipment
• Injection molding machines
• Ultrasonic cleaning equipment
• Packaging equipment
• Computer-aided design (CAD) software

Common products and services typical of NAICS Code 334510-04, illustrating the main business activities and contributions to the market.

• Implantable pacemakers
• Cardiac resynchronization therapy (CRT) devices
• Implantable cardioverter defibrillators (ICDs)
• Leadless pacemakers
• Subcutaneous ICDs
• Biventricular pacemakers
• Wireless pacemakers
• Implantable loop recorders
• Cardiac monitors
• External pacemakers

The specific certifications, permits, licenses, and regulatory compliance requirements within the United States for this industry.

• Quality System Regulation (QSR): The QSR is a set of regulations that medical device manufacturers must follow to ensure that their products are safe and effective. The regulations are enforced by the FDA and cover all aspects of the manufacturing process, from design to distribution.
• ISO 13485: ISO 13485 is an international standard that specifies the requirements for a quality management system for medical device manufacturers. Compliance with this standard is often required by regulatory agencies around the world.
• Good Manufacturing Practices (GMP): GMP is a set of guidelines that ensure that medical devices are consistently produced and controlled according to quality standards. Compliance with GMP is required by the FDA for medical device manufacturers.
• Medical Device Reporting (MDR): MDR is a regulation that requires medical device manufacturers to report any adverse events related to their products to the FDA. Compliance with MDR is required by the FDA for medical device manufacturers.
• Unique Device Identification (UDI): UDI is a system that requires medical device manufacturers to label their products with a unique identifier. The system is designed to improve patient safety and make it easier to track medical devices throughout their lifecycle. Compliance with UDI is required by the FDA for medical device manufacturers.

A concise historical narrative of NAICS Code 334510-04 covering global milestones and recent developments within the United States.

• The "Pacemakers-Cardiac (Manufacturing)" industry has a long and fascinating history. The first pacemaker was invented in 1950 by Canadian electrical engineer John Hopps. The device was a large, external machine that used electrical impulses to stimulate the heart. In 1958, the first implantable pacemaker was developed by American engineer Wilson Greatbatch. This device was much smaller and could be implanted directly into the patient's chest. Since then, pacemakers have become increasingly sophisticated, with new features such as wireless connectivity and automatic adjustment to the patient's activity level. In recent years, there has been a growing trend towards miniaturization, with companies developing pacemakers that are small enough to be implanted directly into the heart muscle. In the United States, the "Pacemakers-Cardiac (Manufacturing)" industry has been a major player in the medical device sector for many years. The industry has seen significant growth in recent years, driven by factors such as an aging population and increasing awareness of heart disease. In 2019, the global market for pacemakers was valued at $5.4 billion, with the United States accounting for a significant portion of this total. Major players in the industry include Medtronic, Abbott Laboratories, and Boston Scientific. In the coming years, the industry is expected to continue to grow, driven by factors such as technological advancements and increasing demand for minimally invasive procedures.

The anticipated future trajectory of the NAICS 334510-04 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

• Growth Prediction: Growing

  The future outlook for the Pacemakers-Cardiac (Manufacturing) industry in the USA is positive. The industry is expected to grow due to the increasing prevalence of cardiovascular diseases and the aging population. Technological advancements in the field of pacemakers, such as the development of leadless pacemakers and remote monitoring systems, are also expected to drive growth. Additionally, the increasing demand for minimally invasive surgeries and the rising adoption of pacemakers in emerging economies are expected to create new opportunities for the industry. However, the industry may face challenges such as regulatory hurdles and the high cost of pacemakers, which may limit the growth of the industry.

Recent groundbreaking advancements and milestones in the Pacemakers-Cardiac (Manufacturing) industry, reflecting notable innovations that have reshaped its landscape.

• Medtronic's Micra AV: The world's smallest pacemaker with atrioventricular (AV) synchrony, which allows the device to adjust the timing of the heartbeat between the atria and ventricles.
• Abbott's Gallant: A pacemaker that uses artificial intelligence to adapt to a patient's changing needs and reduce the risk of unnecessary pacing.
• Boston Scientific's LUX-Dx: A pacemaker that can detect and diagnose irregular heartbeats, allowing for more accurate diagnosis and treatment.
• Biotronik's Acticor/rivacor: A pacemaker that uses MRI-safe technology, allowing patients to undergo MRI scans without the need for device removal.
• Medtronic's Percepta: A pacemaker that uses a neural network to monitor and detect changes in a patient's heart condition, allowing for more personalized treatment.