Design & Testing

Inside the OEM: Intuitive Surgical

For nearly three decades, Intuitive Surgical has been a leader in robotic-assisted surgical systems. The company is driven by creating a healthcare future that is less invasive and where diseases are identified early and treated quickly. As a mature company, Intuitive is focusing on adoption of its systems.

Gel-Coated Tubes Flying on SpaceX CRS-29 Will Investigate How the Mucus Lining of the Lungs Affects Drug Delivery

Approximately 10 percent of babies in the U.S. are born prematurely, which puts them at risk for developing respiratory...

The Consultant, the FDA, and You

Understanding what the FDA really means by their time frames, knowing how to address their regulatory issues, and preparing a response to a 483 or Warning Letter is critical to showing the FDA that you understand what they expect from you and that you will work to bring your company into compliance. Another critical point is to understand that you can negotiate with the agency.

Report: WHO’s Move for Regulation of AI in Healthcare Highlights Risks Posed by Usage of AI Tools

The World Health Organization (WHO) has outlined several considerations for the regulation of artificial intelligence (AI) in healthcare....

Flambeau Medical Markets Group Partners with Two Styx Capital

Flambeau Medical Markets Group, part of the Nordic Group of Companies, has partnered with Two Styx Capital (TSC). The company will continue to operate as Flambeau Medical...

FDA Establishes Advisory Committee on Digital Health Technologies

The U.S. Food and Drug Administration has created a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to...

Global Fund, Siemens Healthineers to Accelerate AI Adoption for Tuberculosis Diagnosis

Siemens Healthineers and theGlobal Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund), announced a partnership at the World Health Summit to...

A Flexible Future: Market Analysis of Flexible Packaging for Healthcare

The healthcare sector is always changing with new advancements and approaches emerging. One area that has experienced progress in recent times is flexible packaging....

Cadence Acquires ARC Group Worldwide’s Florida Location

Cadence, Inc., a provider of design, development, and contract manufacturing services to the medical device, drug-delivery, and diagnostics markets, has acquired the Florida location of...

FDA Awards Nearly $7.5 Million to Foster Pediatric Device Development

To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to...

Guest Editorial

Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.

From the Editor - Where to Go to Grow Your Medtech Start-Up

Where are the medtech opportunities in the future? Find out from Editor and Director of Medical Content Sherrie Trigg the markets with top-10 life sciences talent pools.

SHOW PREVIEW

Keep the pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders. It’s all waiting at the region’s most comprehensive medical design and manufacturing event — MD&M Minneapolis — part of Advanced Manufacturing Minneapolis.

Show Preview: Biosensors for Medical Wearables

SAE Media Group’s 3rd Annual Biosensors for Medical Wearables Conference will be back for 2023 in Boston to bring together device developers, medtech, component manufacturers, and big pharma to share and discuss the exciting advances in the medical wearable technology landscape.

Artificial Organs

What medical device would come to shape modern medical practice around the use and development of artificial organs?

NIH Awards $3M to BioSensics to Develop First-in-Kind Wearable Sensor

BioSensics, Newton, MA, has received a $3 million, three-year award from the U.S. National Institutes of Health (NIH). This grant will support the development of a...

Sterling Medical Devices and RBC Medical Innovations Rebrand as Vantage MedTech

Sterling Medical Devices and RBC Medical Innovations has rebranded the combined company as Vantage MedTech. According to the company, leveraging decades of industry...

Excelitas Technologies to Acquire Heraeus Noblelight Business

Excelitas Technologies Corp., which produces photonic solutions for the industrial and medical markets, has signed a definitive agreement with Heraeus Group (Hanau, Germany) to...

Breaking Barriers in Drug Delivery with Better Lipid Nanoparticles

A collaboration between Lawrence Berkeley National Laboratory and Genentech, a member of the Roche Group, is working to break through drug-delivery bottlenecks by designing...

Adhesive Film Offers Pain-Free Drug Delivery

A team of researchers has recently developed easy-to-use oral films that enable painless, efficient, and discreet drug administration. The novel oral film releases drugs into the bloodstream via...

Joint Venture: SABIC, SINOPEC Open PC Plant

SABIC and SINOPEC announced the commercial operation of a new polycarbonate (PC) plant at their 50–50 joint venture (JV) — SINOPEC SABIC Tianjin Petrochemical Co. Ltd. (SSTPC). Khalid Hashim...

Inside the OEM: Smith & Nephew

With COVID behind them and patients and their physicians returning to elective procedures, Smith & Nephew is seeing strong market revenue growth in 2022, according to CEO Deepak Nath, who spoke during its first quarter trading update.

AdvaMed: EPA’s EtO Proposals Create Significant Risk of a Healthcare Crisis

The EPA issued two separate proposals earlier this year covering the use of EtO for device sterilization: the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act.

Hydrogels as a Drug-Delivery Medium

Hydrogels are a proven material used within the wound care industry. They are valued for their cooling, soothing, healing properties, and absorptive characteristics. Outside of the field of wound care, the applications of hydrogels have been expanded into the drug-delivery space.

The Crucial Role of Cleaning in Achieving Process Validation for Electronic Medical Devices

Cleaning plays a crucial role in process validation for manufacturing electronic medical devices. It ensures the highest performance, reliability, and safety levels. Cleaning removes contaminants that can compromise device functionality and longevity.

PRI Launches New Program to Help Companies Improve Manufacturing, Quality

The Performance Review Institute (PRI) has launched a new service designed to help companies improve manufacturing and quality management and improve business...

Paragonix Technologies Receives FDA Clearance for BAROguard Donor Lung Preservation System

Organ transplant developer, Paragonix Technologies has received FDA clearance for its next-generation donor lung preservation system, BAROguard™....

New Device Enables More Holistic and Efficient Testing of PPE

A team at Sandia National Laboratories has developed a faster and more comprehensive way of testing personal protective equipment, or PPE. The basic principle: modeling a device...

Critical Manufacturing Expands Operations into Mexico

Critical Manufacturing, a developer of manufacturing execution systems (MES) for global, multi-site operations, has expanded into Mexico, reinforcing its commitment to delivering...