Industry News
Medical Device Industry News
The EU AI Act: How Will It Impact Medical Device Manufacturers?
A look at the European Union's endorsement of the pioneering AI Act, focusing on its implications for medical device manufacturers, challenges faced by notified bodies in conformity assessments, provisions to support small- and medium-sized businesses
BioSig’s Ridiculously Sparse Layoff Announcement Reeks of Callousness
This week in Pedersen’s POV, our senior editor chides BioSig Technologies for what she sees as an embarrassing PR blunder.
Sourcing Electrical Components: Are We Back to Normal?
The global supply chain was shaken when COVID-19 hit in 2020. An expert details its impact on the current supply landscape, and any lingering pain points.
Your Smartwatch Can’t Measure Blood Glucose Levels… Yet
FDA warns of the unauthorized sale of smartwatches and smart rings falsely claiming non-invasive technology to measure blood glucose.
Medtech in a Minute: Medtronic Pulls the Plug on Ventilators and More
Catch up on the latest medtech news – in one minute or less.
PVC Safe and Effective in Medical Devices and Packaging, Study Claims
A new report by the European Chemicals Agency confirms the safe production of PVC in Europe and recognizes its importance in medical device and packaging applications.
The Good, The Bad, and The Ugly in Medtech Deals
Some deals work and some deals don’t. A look at the good, bad and ugly deals in recent medtech history.
Smart Artificial Urinary Sphincter Advances Bid for FDA Approval
UroMems meets the six-month primary endpoint for the “first-ever” female implanted with its automated artificial urinary sphincter.
The Coming Restrictions on Forever Chemicals
Given the widespread use of PFAS, industries, like medical devices and biopharmaceuticals, are concerned about potential disruptions.
Sustainable Manufacturing Expo Hits North America
Informa Markets Engineering, an international trade show and conference producer, has launched the first manufacturing event devoted entirely to sustainability.
Medtronic Doubles Down on Sustainability Efforts
The Dublin-based company has tapped Raman Venkatesh to be its first VP & Chief Sustainability Officer.
Top Medical Device M&A
A look at the mergers and acquisitions that are shaping the industry.
Freudenberg Medical Expands Manufacturing Footprint in Costa Rica
The $25 million facility will be dedicated to the assembly of high-volume minimally invasive catheters and other medical devices that require precision manual assembly.
FDA Urges Independent Verification of Third-Party Testing Data
The agency is reminding medical device companies to evaluate reliability of third-party testing before FDA submission citing uptick of fabricated, duplicated, and unreliable data.
3M’s Healthcare Business to Stand on Its Own in April
Solventum will focus on wound care, healthcare IT, oral care, and biopharma filtration.
BioSig Cuts a Substantial Number of Positions
The West Port, CT-based company said it was also significantly reducing business operations.
Philips BrightView Imaging System Hit with Class I Recall
The SPECT machine’s detector and support components have the potential to fail and not be able to complete the image or fall and harm the patient.
Medtronic Exits Ventilator Market, Raises FY24 Outlook
The company said its decision to exit the product line comes down to an ‘increasingly unprofitable’ environment.
Medical Device Suppliers Unite to Form the WCDA
The West Coast Device Alliance members are Eagle Medical, West Pak, Pacific BioLabs, Blue Line Sterilization Services, and Steri-Trek.
AngioDynamics Continues Move Away from Manufacturing with Divestitures
The Latham, NY-based company shed its Picc and midline product portfolios to Spectrum Vascular.