Design & Testing

Regulatory

What consumer technology device became the first FDA-approved over-the-counter (OTC) assistive hearing device for adults with mild to moderate hearing loss?

Osaka Prefecture Advances Regenerative Medicine with Future Medical Information Dissemination Project

Osaka Prefecture is moving forward with a large-scale initiative to accelerate regenerative medicine and drug discovery through...

Trelleborg Expands European Medical Device and LifeScience Manufacturing

Trelleborg Medical Solutions has opened 43,055 sq ft (4,000 sq m) of manufacturing space in Hal-Far, Malta, helping medical device and life science customers bring...

Nelson Labs Expands Laboratory Capacity and Services in Germany

Nelson Labs, a provider of microbiological testing, analytical chemistry testing, and advisory services, has expanded its state-of-the-art laboratory space at its Wiesbaden,...

Product of the Month

See the product of the month: MethodSense's Elsa & AI Resource Center at MethodSense.com. Read on to learn more about it.

New Products and Services

See the new products and services, including Dickson's mapping suite designed to streamline the identification of critical hot and cold zones and the analysis of temperature and humidity trends; Littelfuse's series of sealed tactile switches for surface-mount technology; Mahr Inc.'s height gage designed for ease of use and efficiency in production environments; and more.

From The Editor: Australia’s Medtech Investment Signals Global Shift and Opportunity for U.S. Partners

Australia is entering the global medical technology arena with a strategic investment package totaling $65.5 million, aimed at accelerating R&D, manufacturing, and commercialization. Backed by the Australian government, the move signals a deepening commitment to innovation-driven self-reliance — and opens the door to new global partnerships, including with U.S. medical device firms. Read on to learn what this means.

Inside the OEM: Stryker Thrives Amid Global Headwinds

This article examines how Stryker is executing its strategies in a complex and evolving macroeconomic environment, balancing the pressures of inflation, supply chain constraints, and global competition while driving operational discipline, expanding its differentiated robotics portfolio, launching new trauma systems, and leveraging tuck-in acquisitions.

Nelson Labs to Double Cleanroom Capacity to Support Growing Demand for Sterility Assurance Service

Nelson Laboratories, a global leader in microbiological and analytical testing services for the medical device and pharmaceutical industries,...

Growing a Whole-Brain Organoid

Johns Hopkins University researchers have grown a novel whole-brain organoid, complete with neural tissues and rudimentary blood vessels — an advance that could usher in a new era of research into neuropsychiatric disorders such as autism.

Researchers Pioneer Advanced Mechanical Heart Valve

A team of researchers has been testing a mechanical heart valve created in their lab which may, after clinical trials, supersede mechanical valves currently available for people living...

PRIME Project Launches to Strengthen Nitinol Supply Chain

Five leading companies in the medical device industry have launched the PRIME project — a strategic initiative dedicated to advancing the consistency, scalability, and performance of...

Product of the Month

See the product of the month: SGS has received EPA approval as a recognized third-party certification body for testing and certification of magnetic resonance imaging (MRI) machines under the ENERGY STAR® label. The certification allows brands and manufacturers to demonstrate that a device uses less energy in ready to scan mode as well as via an automated power down to an energy saving low power state. Read on to learn more.

Inside the OEM: Boston Scientific to Focus on Cardiology Innovation

At a time when many medtech firms are grappling with regulatory headwinds, pricing pressures, and geopolitical disruptions, Boston Scientific is focused, aligned, and thriving. Read on to learn about the company’s growth in electrophysiology, strength in LAAC, disciplined margin expansion, and much more.

Medical Device Makers: Ask These 7 Questions for an Effective Wireless Test Program

This article presents seven critical questions that medical device designers should be asking as they build the next generation of wireless products to improve quality of life for millions of patients. Read on to learn what they are.

Burn, Freeze, Shock, or Shear: The Expanding Frontiers of Ablation Therapies

Ablation therapies have become indispensable in modern medicine, and their influence will only grow as innovation drives less-invasive, more-effective solutions. The next wave of advancements is likely to emerge from the convergence of technologies, leveraging engineering, biology, and clinical insights to overcome current limitations. Read on to learn more.

Test and Measurement: Regulatory Updates and Strategic Implications

The regulatory and testing landscape for medical devices is shifting in real time. Standards are being revised. Read on to learn what this means.

Regulatory

In May 2004, FDA issued a guidance document that reclassified certain dental implants from Class III to Class II, thereby reducing regulatory burdens while maintaining safety standards. What type of dental implants were...

Tariffs Are Now a Strategic Variable: How MedTech Manufacturers Are Splitting Their Response

The Trump administration’s 2025 trade policy has presented a challenge for U.S. medical device manufacturers: how to respond to escalating tariffs on...

Video Spotlight on Products and Services

See where the video spotlight is this month: on CNC machining; micro linear actuators; a lab tube cutting machine; the 601 series Air Turbine Spindle® mills at 90,000 RPM; MD® multipurpose adhesives; and much more.

Solving Post-Production Cleaning Challenges in Medical Device Manufacturing

Successful post-production cleaning in medical device manufacturing requires a comprehensive approach that addresses multiple challenges simultaneously. Read on to learn more about it.

Technology

In April 2004, FDA approved what kind of system allows to treat epilepsy?

U.S. Tariffs: Implications and Strategies for Medtech Manufacturers

In a dramatic shift that could reshape the medical device industry, the U.S. government’s sweeping tariff hikes — particularly a 125 percent levy on Chinese goods — have...

Inside the OEM GE Healthcare: Navigating Innovation, Growth, and Market Dynamics

GE Healthcare has undergone a marked transformation in recent years, positioning itself further as a leader in medical technology imaging. This article explores the company’s innovation strategies, margin improvements, and market insights while also addressing key challenges over the past year and looking at future opportunities for the company.

BD’s Business Split: A Game-Changer for IVD Market

Becton Dickinson’s (BD) decision to separate its biosciences and diagnostic solutions businesses is sending ripples through the in-vitro diagnostic (IVD) sector. BD says the separation was the result of a comprehensive business portfolio evaluation launched in early 2024. Read on to learn more.

Technology

March 3rd is recognized as World Hearing Day. One of the most significant medical device innovations for hearing impairment is the cochlear implant. In what year was the first commercially available multi-channel cochlear implant...

Proposed Surgical Devices Standard Covers Properties for Nickel Titanium Alloy

ASTM International’s medical and surgical devices committee (F04) is developing a proposed standard for a wrought nickel-titanium alloy. The alloy covered by the...

Boston Scientific to Acquire SoniVie Ltd.

Boston Scientific Corporation has entered into a definitive agreement to acquire SoniVie Ltd., a privately held medical device company that has developed the TIVUS™ Intravascular Ultrasound System....