MDDI Medical Device and Diagnostic Industry News Products and Suppliers

The largest public hospital in the country will receive the latest mammography tech and hands-on training to improve breast cancer detection, diagnosis, and treatment.

https://www.mddionline.com/business/rsna-ge-healthcare-collab-to-bring-advanced-mammography-technology-to-tanzania

The medtech news you need. In one minute or less.

https://www.mddionline.com/qa-qc/medtech-in-a-minute-us-authorities-throw-the-book-at-philips-and-more

The partnership will scale up production of ReadyGo Diagnostics’ signature device and give it global reach.

https://www.mddionline.com/ivd/porex-partners-with-uk-based-diagnostics-startup

The company is urging customers to update the device software in order to mitigate noted software anomalies.

https://www.mddionline.com/regulatory-quality/fresenius-kabi-usa-infusion-pump-software-recall-declared-class-i

The company is on track to be the fastest-growing company in medtech again this year.

https://www.mddionline.com/business/abbott-has-a-powerful-product-lineup-in-the-chamber

Consider these tips for engineering sustainability into products and processes without compromising performance and safety.

https://www.mddionline.com/manufacturing/ensuring-today-s-innovations-do-not-become-tomorrow-s-problems

Recent approvals in the TAVR and TMVR markets are providing significant opportunities for companies like Vivasure Medical. The Galway, Ireland-based company recently said the first large-bore ven...

https://www.mddionline.com/cardiovascular/vivasure-opens-up-about-securing-a-top-spot-in-vessel-closure-market

Categorized as a correction, not product removal, the company is recommending physicians not use the aliquot technique to deliver the Obsidio Conformable Embolic due to increased patient risk.

https://www.mddionline.com/regulatory-quality/boston-scientific-class-i-recall-linked-to-two-deaths

The study will evaluate whether portable MR brain imaging can reliably identify brain swelling and bleeding associated with Alzheimer’s amyloid-targeting therapy at the same time as infusions t...

https://www.mddionline.com/neurological/hyperfine-enrolls-first-patients-in-swoop-care-pmr-study

The company's chairman and CEO hinted at the possibility of more M&A during a recent earnings call.

https://www.mddionline.com/ma/is-more-m-a-in-j-j-s-future-

EarliTec's CTO shares how the company’s autism diagnostic and assessment technology makes diagnosing autism easier for clinicians and families while avoiding common AI pitfalls.

https://www.mddionline.com/artificial-intelligence/a-better-ai-tool-for-diagnosing-assessing-autism

The act lays down the law for artificial intelligence development and usage, dishing out hefty fines and a laundry list of must-dos for outfits dabbling in AI.

https://www.mddionline.com/artificial-intelligence/what-digital-health-startups-need-to-know-about-the-eu-ai-act

The VSP PEEK Cranial Implant system includes a complete FDA-cleared workflow comprising segmentation and 3D-modeling software, a printer developed by 3D Systems, and PEEK resin from Evonik.

https://www.mddionline.com/implants/3d-printed-peek-cranial-implants-cleared-by-fda

Long-term buildup of biomaterials can obstruct the device, making it less effective at helping the heart pump blood.

https://www.mddionline.com/qa-qc/14-deaths-connected-to-latest-abbott-heartmate-recall

The Basel, Switzerland-based company’s test looks for the presence of amyloid pathology in patients suspected of having Alzheimer’s.

https://www.mddionline.com/ivd/roche-lands-breakthrough-designation-for-alzheimer-s-test

This week in Pedersen's POV, our senior editor pushes for patient access to breakthrough medical devices.

https://www.mddionline.com/medical-device-regulations/fueling-the-fire-of-access-to-emerging-medical-devices

Here’s how you can be the leader you’ve always wanted to be, even within the prescribed limits of industry regulations.

https://www.mddionline.com/packaging/how-to-be-a-packaging-visionary-in-pharma-and-medtech

In this Q&A, MD+DI investigates the connection between how better collaboration among academic institutions and industry could improve the production of medical devices.

https://www.mddionline.com/rd/bridging-the-gap-between-research-medical-device-development

Bethany Corbin, a recognized thought leader in women's health, is set to keynote IME South. The six-in-one advanced design and manufacturing expo returns June 4-6 to the Charlotte Convention Cent...

https://www.mddionline.com/manufacturing/feminnovation-ceo-to-keynote-biennial-informa-markets-engineering-south-tentpole-manufacturing-event

Illumina hopes to finalize the plan with EU regulators sometime in 2Q24.

https://www.mddionline.com/ivd/eu-regulators-approve-illumina-s-plan-to-divest-grail

A Widex product designer shares insights behind the design of the company's newest hearing aid.

https://www.mddionline.com/design-engineering/behind-the-design-form-follows-function-in-new-l-shaped-widex-hearing-aid

The decree restricts manufacturing and distribution of devices at or from Philips Respironics facilities in PA and CA until it has completed repair, rework, replacement, and refund activities.

https://www.mddionline.com/qa-qc/philips-faces-consent-decree-that-restricts-sales-of-new-sleep-apnea-devices

Analysts discuss the potential impact of a clinical trial that had Medtronic’s Evolut technology go head-to-head with Edward’s Sapien platform.

https://www.mddionline.com/cardiovascular/is-the-smart-trial-a-game-changer-for-tavr

Medical Microinstruments reported it has received a De Novo Classification for its Symani Surgical System.

https://www.mddionline.com/robotics/there-s-a-new-surgical-robotics-solution-in-town

Fresh off a $42 million series A financing, Reprieve Medical is developing an intelligent automated fluid management system for heart failure patients.

https://www.mddionline.com/startups/new-cardiovascular-company-emerges-from-stealth-mode

The acquisition will enhance its manufacturing capabilities, technology, and geographical footprint, said Atalys.

https://www.mddionline.com/business/medical-injection-molder-schnipke-acquired-by-atalys

The cardiovascular market is one of the hottest segments in the medical device industry. MD+DI looks at the companies making the most noise in cardiology.

https://www.mddionline.com/cardiovascular/6-most-influential-cardiovascular-companies

The tech giant said the decision to ban the watches were made relying on Masimo patents that were “purely hypothetical” when filing the complaint in 2021.

https://www.mddionline.com/wearable-medical-devices/apple-asks-appeals-court-to-reverse-smartwatch-import-ban-as-masimo-patent-battle-continues

Asensus Surgical was once poised to take on Intuitive Surgical. Now the company clings to a life preserver from a prospective buyer.

https://www.mddionline.com/ma/a-drowning-medtech-company-clings-to-a-life-preserver

University of Michigan research showcases how automated laboratories expedite chemical testing, enabling transformative battery advancements.

https://www.mddionline.com/components/new-approach-automated-lab-streamlines-battery-chemistry-testing

The recall comes after reports of cracking at the distal catheter shaft, possibly resulting in patient injury.

https://www.mddionline.com/regulatory-quality/medos-cerenovus-cerebase-da-guide-sheath-recall-categorized-as-class-i

This week in Pedersen’s POV, our senior editor revisits the trend of “biggering” in the medical device industry through a new lens.

https://www.mddionline.com/ma/medtech-mega-mergers-cautionary-tale-or-compelling-growth-strategy-

The news you need. In one minute or less.

https://www.mddionline.com/cardiovascular/medtech-in-a-minute-abbott-s-big-fda-approval-and-more

An FTC request stalls Boston Scientific's acquisition of Axonics.

https://www.mddionline.com/ma/high-profile-merger-hits-a-regulatory-roadblock

The New Brunswick, NJ-based company could strengthen its position in the cardiovascular intervention market with this $13.1 billion acquisition.

https://www.mddionline.com/ma/j-j-puts-the-rumors-to-bed-moves-to-acquire-shockwave

Keeping you up to date on all the medical device supplier news.

https://www.mddionline.com/ma/new-hires-m-a-dominate-medical-device-supplier-news

The recall reported the possibility of the devices producing continuous positive gas flow instead of the intended cycling when switched to the ventilate operating mode.

https://www.mddionline.com/regulatory-quality/smith-medical-recalls-pneupac-parapac-plus-300-310-ventilator-kits

The kits are being recalled after reports of increased resistance in the guidewire handle and chamber during use.

https://www.mddionline.com/regulatory-quality/teleflex-arrow-international-recall-arrow-quickflash-radial-artery-and-radial-artery-arterial-line-catheterization-kits

3D printing is taking the manual labor and guesswork out of reconstructive and implantable device design while improving patient comfort.

https://www.mddionline.com/3d-printing/new-bodies-of-work-for-3d-printing

U.S. patients suffering from a leaky tricuspid valve now have a new treatment option.

https://www.mddionline.com/cardiovascular/what-abbott-s-big-fda-approval-means-for-the-tricuspid-repair-market

The letter of intent also includes an exclusivity period of up to 10 weeks where Asensus will not be able to engage in negotiations for alternative transactions.

https://www.mddionline.com/ma/asensus-surgical-enters-non-binding-acquisition-proposal-with-karl-storz

A pilot project involving Sabic and the dialysis department of a major Belgian hospital puts medical plastic waste on a circular path.

https://www.mddionline.com/materials/medical-plastic-waste-gets-new-lease-on-life-via-advanced-recycling

Patients appreciate the comfort, convenience, and confidentiality of testing and treating themselves where they live.

https://www.mddionline.com/packaging/medical-test-kits-find-a-new-home

The tool will enable ejection fraction detection quickly and accessibly using an Eko stethoscope during a routine physical exam.

https://www.mddionline.com/artificial-intelligence/eko-health-nabs-fda-clearance-for-low-ef-detection-ai

The companies announced a settlement yesterday after years of litigation.

https://www.mddionline.com/business/angiodynamics-bd-end-years-long-bard-patent-dispute

Lutronic and Cynosure have merged to become a powerhouse in the medical aesthetics market.

https://www.mddionline.com/ma/cynosure-s-new-life-after-hologic-includes-a-merger

A rotating wheel, mounted on a card, safeguards the suture and makes it easy to uncoil.

https://www.mddionline.com/packaging/suture-pack-pops-a-wheelie

In the world of medtech, the journey from a groundbreaking idea to a marketable product is not always straightforward.

https://www.mddionline.com/startups/beyond-science-convincing-your-way-to-commercialization

This week in Pedersen's POV, our senior editor shares not-so-hilarious recovery tales from her foot surgery.

https://www.mddionline.com/orthopedic/my-knee-scooter-is-the-goat-of-mobility-devices

Take a closer look at some of FDA’s recent pharmaceutical and medical device recalls where packaging has played a role.

https://www.mddionline.com/packaging/disturbing-healthcare-recalls-in-1q2024