• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates

News Well

FDA clears Acutus’ AcQCross system for use with Boston Scientific’s Watchman

June 27, 2022 By Sean Whooley

Acutus Medical (Nasdaq:AFIB) announced today that it launched an expanded suite of left-heart access products. Following expanded FDA clearance, Acutus launched the suite to now include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Boston Scientific Watchman left atrial appendage closure device. Carlsbad, California-based Acutus designed the AcQCross […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Structural Heart, Wall Street Beat Tagged With: Acutus Medical, Boston Scientific

They said it at DeviceTalks Boston

June 24, 2022 By Jim Hammerand

Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead. Here are some of the most quotable insights from panelists and speakers at our live event. And make sure to save the date — and save your seat […]

Filed Under: Blog, Featured, News Well Tagged With: Activ Surgical, Avail Medsystems, Boston Scientific, DeviceTalks Boston, Harvard, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Insulet, Medtech Innovator, Medtronic, Proximie, Stryker

Haemonetics completes move to new Pennsylvania manufacturing facility

June 24, 2022 By Sean Whooley

Haemonetics (NYSE:HAE) announced today that it fully commenced operations at its new manufacturing center in Clinton, Pennsylvania. Boston-based Haemonetics previously operated at a manufacturing plant in nearby Leetsdale, Pennsylvania, from 1990 until now. According to a news release, the custom-built facility constitutes approximately 200,000 square feet in Clinton Commerce Park near Pittsburgh International Airport. Initial […]

Filed Under: Blood Management, Business/Financial News, Contract Manufacturing, Featured, News Well Tagged With: Haemonetics

Another Medtronic HVAD recall is serious

June 23, 2022 By Chris Newmarker

A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, News Well, Recalls, Regulatory/Compliance, Structural Heart Tagged With: Abbott, LVAD, Medtronic

Baxter’s Volara lung therapy system recall is Class I

June 23, 2022 By Sean Whooley

The FDA issued a notice today labeling the recall of the Baxter (NYSE:BAX) Volara lung therapy system as Class I, the most serious kind. Earlier this month, Baxter announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. To date, there has been one complaint […]

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: Baxter, FDA, Hillrom

BD voluntarily recalls intraosseous products

June 23, 2022 By Sean Whooley

BD (NYSE:BDX) announced that it issued a voluntary recall for select lots of a trio of its intraosseous products. Franklin Lakes, New Jersey-based BD’s recall covers its Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits and Intraosseous Powered Drivers. According to a news release, certain lots within the expiration date of the affected products may […]

Filed Under: Featured, News Well, Orthopedics, Recalls, Regulatory/Compliance Tagged With: BD

How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

June 22, 2022 By Jim Hammerand

SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]

Filed Under: Blog, Clinical Trials, Dialysis, Featured, Food & Drug Administration (FDA), News Well, Pediatrics, Regulatory/Compliance, Research & Development Tagged With: covid, COVID-19, FDA, SeaStar Medical

Illumina, Merck launch test for cancer development, progression insights

June 22, 2022 By Sean Whooley

Illumina (Nasdaq:ILMN) announced today that it launched a new research test, co-developed with Merck (NYSE:MRK). The jointly developed test adds the assessment of a new genomic signature to the already distributed TruSight Oncology 500 assay, enabling researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, News Well, Oncology Tagged With: Illumina, Merck

Abbott to open new offices in downtown Chicago

June 22, 2022 By Chris Newmarker

Abbott (NYSE: ABT) will open offices in the iconic Willis Tower in downtown Chicago, a company spokesperson confirmed to MassDevice. The company’s headquarters will stay in the northern suburbs, in Lake County, but the new downtown space will help accommodate flexible working arrangements for up to 450 Abbott employees, according to company spokesperson Scott Stoffel. […]

Filed Under: Business/Financial News, Featured, News Well

FDA grants breakthrough nod for Carthera’s SonoCloud-9

June 22, 2022 By Sean Whooley

Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]

Filed Under: Bioelectronic Medicine, Clinical Trials, Featured, Food & Drug Administration (FDA), Implants, Neurological, Neuromodulation/Neurostimulation, News Well, Oncology, Regulatory/Compliance, Ultrasound Tagged With: CarThera, FDA

Teleflex enrolls first patient in vascular closure device study

June 22, 2022 By Sean Whooley

Teleflex (NYSE:TFX) announced today that it enrolled the first patient in a clinical study of its Manta vascular closure device. In the study, Wayne, Pennsylvania-based Teleflex intends to demonstrate the safety of Manta ultrasound-guided closure without dependence on the pre-procedural depth locator measurements. According to a news release, the study will enroll up to 150 […]

Filed Under: Cardiovascular, Clinical Trials, News Well, Structural Heart, Vascular Tagged With: Teleflex

  • « Go to Previous Page
  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Go to page 4
  • Go to page 5
  • Interim pages omitted …
  • Go to page 1626
  • Go to Next Page »

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS