The F15 recharge-free sacral neuromodulation system is indicated for the treatment of adults with overactive bladder.
The agency continues to recommend healthcare providers use syringes not manufactured in China after reports of leaks, breakage, and problems after syringe dimension changes.
The company will feature miniaturized parts and components that cater to the medical industry’s demand for increasingly complex geometries.
https://www.mddionline.com/manufacturing/accumold-brings-medial-micro-molding-to-md-m-south
The company announced the product recall after identifying an unintended change of device power state.
https://www.mddionline.com/regulatory-quality/masimo-recalls-certain-radg-pulse-oximetry-devices
The biocompatible formulation from Sabic combines processability with chemical resistance.
https://www.mddionline.com/diabetes/medical-grade-pbt-resin-suited-for-molding-diabetes-device-parts
The Tokyo, Japan-based company unveiled a prototype during the 2024 Institute of Electrical and Electronics Engineers (IEEE) International Conference on Robotics and Automation.
Human-centric design allows design engineers to focus on the challenges they want their products to solve and not be distracted by trends.
Trivia Tuesday: What medical device company became embroiled in a fight with FDA that ultimately led to disciplinary action against two agency employees and the unseating of two advisory panel me...
The warning letter urges users and providers to throw the entire test cartridges in the trash due to the increased risk of false results.
https://www.mddionline.com/ivd/a-warning-letter-is-the-latest-roadblock-for-cue-health
The company said that if a specific combination of factors comes together, there is a risk of thermal injury.
In part 3 of MD+DI’s interview with Jim O’Connell, he details the potential longevity for connected care in medtech, as well as the challenges it could face.
https://www.mddionline.com/business/a-chat-with-baxter-president-of-front-line-care-part-3
Here are the sessions that MD+DI editors are keeping their eyes on during MD&M South.
The recall, which was initiated by the company in March, pertains to a software issue that can cause a possible power malfunction in certain situations.
This week in Pedersen's POV, our senior editor examines Apple's new iPad ad through a medtech lens.
https://www.mddionline.com/digital-health/big-tech-in-medtech-is-apple-pressing-too-hard-
The affected catheters were manufactured by an outside contract supplier, not by the company itself.
A look at the five stages of FDA’s phaseout policy concerning laboratory-developed tests.
https://www.mddionline.com/ivd/5-things-you-need-to-know-about-fda-s-final-rule-on-ldts
The medtech news you need. In 1 minute or less.
Business separation plans appear to have put Masimo back on track, but will another proxy battle derail this progress?
https://www.mddionline.com/wearable-medical-devices/masimo-ceo-our-business-is-back-on-track
Keeping you up to date on the latest supplier news.
https://www.mddionline.com/manufacturing/ess-technologies-eyes-expansion-other-supplier-news
In the last two years, about 100 “students” have learned the Fundamentals of Medical Device Packaging and are putting the knowledge to good use.
https://www.mddionline.com/packaging/new-medical-device-packaging-course-a-hit
Deemed a correction, not product removal, the company is urging customers to update the apps software to mitigate potential issues.
Citing unmet need, Front Line Medical Technologies says its’ device could offer quicker and safer bleeding control in some postpartum hemorrhage scenarios.
The MedTech conference is designed to elevate manufacturing professionals’ expertise in overall product design and development through interactive sessions led by industry pioneers.
https://www.mddionline.com/manufacturing/ime-south-to-drive-innovation-through-medtech-master-class
The agency today sent out a notice recommending that healthcare providers and facilities not use the Cardiosave IABP and Cardiohelp system and HLS sets after continued safety and quality concerns...
The healthcare industry is leading demand for biobased feedstocks because of concern over contamination using recycled-content materials, said the company at NPE.
https://www.mddionline.com/materials/formerra-begins-selling-iscc-plus-certified-materials
Instead of taking over, AI could act as a companion to human engineers throughout the design process and help improve their work along the way. Product Creation Studio CTO Scott Thielman—and no...
The popular new drug class could be a game changer for several medical device sectors, but GLP-1s won't catch ResMed resting on its laurels.
https://www.mddionline.com/medical-device-markets/will-glp-1-drugs-wake-up-the-sleep-apnea-market-
The announcement comes after company CFO told The Washington Post that medtech layoffs were, 'a failure of leadership'.
The German Federal Patent Court has ruled in favor of NanoString in a patent infringement case that has the company pitted against 10X Genomics.
Engineers and designers alike will find kindred spirits at the upcoming event to grow their networks.
https://www.mddionline.com/packaging/make-worthy-connections-at-ime-south-2024
In part 2 of MD+DI’s interview with Jim O’Connell, he highlights the integrated technology landscape for diagnostic cardiology devices.
https://www.mddionline.com/cardiovascular/a-chat-with-baxters-president-of-front-line-care-part-2
An optional accessory for the Tablo Hemodialysis system, the two versions of the cart come with additional storage features and water prefiltration capabilities, respectively.
https://www.mddionline.com/regulatory-quality/outset-medical-nabs-fda-clearance-for-tablocart
Follow these tips when searching for the right third-party testing partner to avoid delays and ensure your product’s smooth journey to market.
This week in Pedersen's POV, our senior editor shares slacker-inspired tips for conquering mandatory training procrastination with a little help from a LinkedIn friend and SpongeBob.
The Apple Watch’s atrial fibrillation tracking features have been given the green light to be used in clinical studies. What does this mean for other companies in the ECG space?
Andrew DiMeo Sr., PhD, emphasizes the significance of a robust strategy and value proposition in medical innovation, advocating for a shift toward mission-driven innovation to align quality and v...
Design engineers have several opportunities to craft technology that promotes safe, independent living for seniors.
The company has seen major revenue loss since the pandemic began to wane, resulting in multiple layoffs.
https://www.mddionline.com/business/cue-health-axes-49-percent-of-staff
The family-owned business reinforces its commitment to quality and evolving regulatory requirements.
https://www.mddionline.com/manufacturing/medical-thermoformer-achieves-iso-13485-certification
This is the second layoff announced by the company so far in 2024.
https://www.mddionline.com/business/medtronic-to-cut-44-jobs-at-carlsbad-california-facility
Keeping you up to date on the latest medical device supplier news.
https://www.mddionline.com/manufacturing/agreements-awards-facility-upgrades-dominate-supplier-news
As Dexcom and Abbott both move closer to over-the-counter launches of continuous glucose monitoring sensors, analysts forecast revenue potential for the new category.
https://www.mddionline.com/diabetes/cgm-coming-soon-to-your-online-shopping-cart
In the study, the device will be evaluated relative to technology that has already been FDA approved.
The recall details that the affected kits contain incorrect concentrations of Ceftriaxone antibiotic in two wells.
Are you interested in an upcoming event but unsure how to gain approval? This quick guide is for you.
https://www.mddionline.com/business/3-easy-steps-to-justify-your-attendance-at-events
The deal follows Labcorp, Quest’s rival, becoming the winning bidder to acquire Invitae’s assets.
Putnam Plastics brings FEP heat-shrink tubing extrusion — minus processing aids — in house, and GlobTek launches a line of PVC cables designed for healthcare environments.
https://www.mddionline.com/components/new-dimensions-in-medical-tubing-and-cables
The final rule is sure to shake up the diagnostic industry, for better or worse, depending on who you talk to.
https://www.mddionline.com/ivd/ldt-oversight-gets-long-awaited-fda-final-rule
The deal comes during a time when M&A is becoming more prevalent in the medtech industry.
https://www.mddionline.com/ma/hologics-set-to-acquire-rival-in-breast-imaging
In part 1 of MD+DI’s interview with Jim O’Connell, he highlights the integration process of Hillrom into Baxter as the acquisition marks two years.
https://www.mddionline.com/ma/a-chat-with-baxter-president-of-front-line-care-part-1