• 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
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

Women's Health

N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard

March 3, 2021 By Nancy Crotti Leave a Comment

A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s  (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard. In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Legal News, Product Liability, Regulatory/Compliance, Women's Health Tagged With: AdvaMed, becton dickinson, C.R. Bard, Ethicon, Johnson & Johnson, pelvic mesh

Boston Scientific to acquire Lumenis surgical business for $1.07B

March 3, 2021 By Sean Whooley Leave a Comment

Boston Scientific (NYSE:BSX) announced today that it entered into a definitive agreement to acquire the global surgical business of Lumenis for nearly $1.1 billion. Marlborough, Mass.–based Boston Scientific, entered into the agreement with an affiliate of Baring Private Equity Asia (BPEA) to acquire the privately-held company’s global surgical business, which develops and commercializes energy-based medical […]

Filed Under: Business/Financial News, Featured, Gynecological, Men's Health, Mergers & Acquisitions, Surgical, Urology, Women's Health Tagged With: Baring Private Equity Asia, Boston Scientific, Lumenis Ltd.

Axonics, Micro Systems Technologies partners to make rechargeable SNM device

March 2, 2021 By Sean Whooley Leave a Comment

Axonics (NSDQ:AXNX) announced today that it entered into a strategic alliance with Micro Systems Technologies. Micro Systems Technologies (MST) manufactures printed circuit board assemblies for the Axonics r-SNM (sacral neuromodulation) system in Lake Oswego, Oregon, according to a news release. The newly minted strategic alliance expands the relationship between the two as the companies collaborate […]

Filed Under: Business/Financial News, Featured, Gynecological, Men's Health, Neurological, Neuromodulation/Neurostimulation, Urology, Women's Health Tagged With: Axonics Modulation Technologies, Micro Systems Technologies

FDA approves first robot-assisted system for transvaginal hysterectomy

March 1, 2021 By Sean Whooley Leave a Comment

The FDA announced today that it authorized marketing for Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy. Hominis is the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy, according to an FDA news release. Using minimally invasive surgical instruments inserted through the vagina and a video […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Regulatory/Compliance, Robotics, Surgical, Women's Health Tagged With: FDA, Memic Innovative Surgery, robot-assisted

Axonics acquires Contura and its Bulkamid bulking agent for $235M

February 25, 2021 By Sean Whooley Leave a Comment

Axonics (NSDQ: AXNX) announced today that it acquired Contura and its flagship Bulkamid product for up to $235 million. London-based Contura’s Bulkamid is a urethral bulking agent for women with stress urinary incontinence (SUI). It is a next-generation hydrogel injected into the urethral wall in a minimally invasive office or outpatient facility procedure to restore the natural […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Gynecological, Mergers & Acquisitions, Pharmaceutical, Women's Health Tagged With: Axonics Modulation Technologies, Contura Inc., hydrogels

UK passes post-Brexit medical device regulation

February 25, 2021 By Nancy Crotti Leave a Comment

The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety. The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by […]

Filed Under: Featured, Pharmaceutical, Regulatory/Compliance, Women's Health Tagged With: U.K. Medicines and Medical Devices Act

Hologic completes Biotheranostics acquisition

February 23, 2021 By Sean Whooley Leave a Comment

Hologic (NSDQ:HOLX) announced that it completed its previously announced acquisition of Biotheranostics for $230 million. Marlborough, Mass.-based Hologic last month announced that it was set to buy Biotheranostics and its two molecular diagnostic tests for breast and metastatic cancers, the Breast Cancer Index and CancerTYPE ID. Both laboratory-developed tests are not required to be cleared by […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, Mergers & Acquisitions, Women's Health Tagged With: bioTheranostics, Hologic

Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women

February 18, 2021 By Sean Whooley

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine […]

Filed Under: Clinical Trials, Pharmaceutical, Women's Health Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, Pfizer

FDA approves expanded labeling for Medtronic InterStim SureScan MRI leads

February 18, 2021 By Sean Whooley

Medtronic (NYSE:MDT) announced today that it received FDA approval for expanded MRI labeling of its InterStim SNM systems. Fridley, Minn.-based Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads were approved under updated MRI guidelines allowing for a wider range of MRI scan parameters and shorter wait times between scans, […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Imaging, Men's Health, Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance, Urology, Women's Health Tagged With: FDA, Medtronic

Federal lawsuit over Boston Sci pelvic mesh heads to trial

February 17, 2021 By Chris Newmarker

A federal judge in Arkansas has ruled that most counts in a pelvic mesh lawsuit against Boston Scientific can go to trial. Kortney Cline sued Boston Sci in 2014, claiming that she suffered injuries after implantation with the company’s Obtryx trans-obturator mid-urethral sling in 2009. Cline’s case was recently transferred to federal court in Arkansas […]

Filed Under: Featured, Gynecological, Legal News, News Well, Product Liability, Women's Health Tagged With: Boston Scientific, pelvic mesh, Pelvic Mesh Lawsuits

GE Healthcare sells molecular breast imaging assets to SmartBreast

February 8, 2021 By Danielle Kirsh

SmartBreast today announced that it has acquired GE Healthcare (NYSE:GE)’s molecular breast imaging assets for an undisclosed amount. The Pittsburgh-based company acquired the Discovery NM750b and other MBI scanner designs, manufacturing tools, instructions and related patents and installed-base service business as part of the deal. SmartBreast will begin to market and distribute the Discovery NM750b and […]

Filed Under: Diagnostics, Imaging, Mammography, Women's Health Tagged With: GE Healthcare, SmartBreast

  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Interim pages omitted …
  • Go to page 79
  • Go to Next Page »

Primary Sidebar

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.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · 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