News

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™....

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...

Intricon to Open Costa Rica Facility Dedicated to Sensor-Driven Medical Devices

Intricon plans to open the first facility in Costa Rica dedicated to the development and manufacturing of medical devices that incorporate microelectronics,...

FDA Updates Catalog of Tools to Assess Medical Devices

The U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding four new tools and updating nine others. The catalog is a peer-reviewed resource...

TÜV SÜD Receives UKAB for Medical Devices

TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and CE...

AI in Healthcare: BioSig Partners with Reified Labs

BioSig Technologies, Inc. announced a new collaboration agreement in June with Reified Labs, a technical advisory service specializing in advanced artificial intelligence (AI). Together,...

MES & Industry 4.0 International Summit to Focus on Impact of Digital Transformation

Portugal’s Secretary of State for Digitalization and Administrative Modernization Mário Campolargo will deliver the inaugural speech at the MES &...

SEMECO to Accelerate Advances in Medical Electronics

Germany-based SEMECO (Secure Medical Microsystems and Communications) future cluster recently launched with partners from the Technische Universität Dresden. The goal is ambitious: to break...

Bending Implantables Enables Infectious Organisms to Take Hold

A study from University of Toronto Engineering researchers shows that mechanical deformation of medically implantable materials — such as bending or twisting — can have a...

MGS Mfg. Group Acquires Denmark-Based Technolution

MGS Mfg. Group, Inc. (MGS), a global provider of integrated manufacturing solutions for complex, high-precision plastic components for healthcare and pharma applications, has acquired...

Mactac Acquires Label Supply, Canadian Distributor of Roll Label Products

Mactac, a LINTEC Company, is acquiring Label Supply, headquartered in Ontario, Canada. Label Supply has been servicing the Canadian roll label market for more than three...

MMT Acquires Ward Automation Galway, Somex: Launches MMT Automation Division

Medical Manufacturing Technologies (MMT), a portfolio company of Arcline Investment Management and a global provider of medical device manufacturing solutions, has...

IVD Market to See Significant Drop in Sales as COVID-19 Emergency Ends

The World Health Organization (WHO) announced on May 5 that COVID-19 is no longer a global emergency. This comes as a relief to the public, but for many medical device...

Acarix, ACC Collaborate on Framework for CADScor System

In collaboration with the American College of Cardiology (ACC), Acarix, a developer of acoustic and AI-based cardiac diagnostics based in Sweden, has released a first edition of a...

NeuroOne Launches Evo sEEG Electrodes in U.S.

NeuroOne Medical Technologies Corp. , a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has announced the...

Survey: MedAccred Offers Continued Value to Medtech Industry

The MedAccred program continues to provide value to medical device manufacturers that have been awarded its prestigious accreditation for critical manufacturing processes, according...

Windsor Agreement: Changes to Northern Ireland Regulatory Landscape

An agreement reached by the UK and EU regarding the Windsor Framework brings changes to the Northern Ireland regulatory landscape. The agreement , in principle, was reached on...

Teleflex Breaks Ground for Manufacturing Facility Expansion

Teleflex Incorporated, a global provider of medical technologies, has broken ground to launch an expansion project for its Teleflex Medical OEM facility in Jaffrey, NH. The project...

FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...

Performance Review Institute Acquires SRI Quality System Registrar

The Performance Review Institute (PRI) has expanded its management systems certification portfolio through the acquisition of SRI Quality System Registrar. SRI is headquartered...

Eitan Medical Opens New Manufacturing Facility Bolstered by Semi-Automated Production Lines

Eitan Medical, a developer of advanced infusion therapy and drug-delivery systems, has opened a new manufacturing facility at the company’s...

Intricon Launches Center of Excellence Exclusively for Biosensor Medical Devices

Intricon, a developer and manufacturer of medical devices powered by smart miniaturized electronics, has launched a new Biosensors Center of Excellence (CoE). The...

Contract Manufacturer Cadence Acquires Utitec, Inc.

Cadence, Inc., a contract manufacturer of medical and drug-delivery devices and specialty commercial products, has acquired Utitec, Inc., a manufacturer specializing in miniature, deep...

Bosch Rexroth Opens New Factory Automation Customer Innovation Center

Bosch Rexroth has opened a new customer innovation center near Austin, TX. The company says the facility will provide a unique technology development experience for Bosch...

Design Firm Veranex Acquires Fusion Biotec

Veranex, Raleigh, NC, has acquired Fusion Biotec, a design and engineering firm for complex electro-mechanical diagnostic instrumentation and medical devices located in Orange, CA. According to the...

Raumedic AG Publishes Sustainability Report

Raumedic AG, Helmbrechts, Germany, has published its first sustainability report based on the internationally recognized standards of the Global Reporting Initiative (GRI). The report relates to the...

Movano Health to File First FDA Submission for Smart Ring’s SpO2 and Heart Rate Data

Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...

OKAY Industries Expands Costa Rica Operations, Joins Evolution Free Zone

OKAY Industries, New Britain, CT, a contract manufacturer of metal and plastic overmolded components and subassemblies for global medical device original equipment...