Industry News
Medical Device Industry News
Empatica Launch Next-Gen FDA-Cleared Epilepsy Watch
The device, according to the company, is the only wearable solution with FDA clearance for seizure detection available for purchase in the US.
Boston Sci Nabs FDA Approval for Agent DCB
The regulatory nod makes the device the first coronary drug-coated balloon indicated for in-stent restenosis for patients with coronary artery disease in the US.
Masimo Takes Apple’s Hail Mary Pass in Stride
The latest remarks from Masimo's CEO about the ongoing patent battle with Apple.
Adverse Events Reported for Hologic BioZorb Marker, BioZorb LP Marker
The marking implant, according to FDA, has the potential to cause infection, fluid buildup, device migration, device erosion, pain, discomfort, and rash, along with other complications.
Wintriss to Display Production Tracking Software & other Supplier News
Keeping you up to date with the latest supplier news.
Behind the Design of the Orchid Safety Release Valve
A behind-the-scenes look at the design inputs, challenges, and breakthrough moments in a quest to create a tension-activated safety release valve for medical tubing applications.
When Medical Device Design Had a Dimensional Dilemma
What advanced manufacturing technology solved a sometimes-costly design problem for medical device companies?
EU Council Endorse New Measures to Prevent Medical Device Shortages
The agreed-upon revisions also include registration updates for the electronic European database on medical devices and an extension to the IVDR transition period for IVDs.
The Top 100 Medical Device Companies
Where does your company rank in the medical device industry?
Integra Shutters Lafayette Plant, Cuts 59 Employees
With the closure, the manufacturing of the Urinary Bladder Matrix portfolio will move to the company’s Columbia, MA, location.
Trelleborg Expands Manufacturing Presence in Australia & China with M&A
Trelleborg said it would acquire Baron Group, a company focused on manufacturing advanced precision silicone components.
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.