Medical Devices: Page 160
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ResMed discloses tentative DOJ settlement, sets aside $41.2M
A resolution to a DOJ probe, disclosed during the sleep apnea device maker's fourth quarter earnings call, would settle an investigation into marketing and financing practices related to the company's resupply program.
By Susan Kelly • July 29, 2019 -
Australia on watch for possible EU notified body shortage
The country's Therapeutic Goods Administration has issued new guidance to aid device makers seeking overseas marketing authorization.
By Susan Kelly • July 29, 2019 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Jacob Bell/MedTech Dive
New delivery system for sinus stent gains FDA approval
Intersect ENT's line of steroid-releasing stents are the first and only dissolvable sinus implants approved by FDA, according to the company.
By Susan Kelly • July 29, 2019 -
Stryker says Mako robot driving orthopaedic share gains
The orthopaedics giant said the robotic surgery system is supporting above-market growth in hip and knee implants, but pressure may soon increase as Zimmer Biomet expands the rollout of Rosa Knee.
By Susan Kelly • July 26, 2019 -
Zimmer Biomet to increase robotics R&D as new CFO takes helm
The company saw its best growth in its knee business in three years during the second quarter, even without contributions from the limited launch of the Rosa Knee system, executives said.
By Maria Rachal • July 26, 2019 -
FDA finalizes biliary stent guide after Cook, Boston Scientific feedback
The final guidance hews closely to the draft released for consultation last year, despite Cook calling for a variety of changes.
By Nick Paul Taylor • July 26, 2019 -
Healthcare the lone growth driver for 3M in Q2
The unit posted 5.8% sales growth, providing some relief for the beleaguered conglomerate, which expects its $6.7 billion buyout of wound care company Acelity to close in the fourth quarter.
By Nick Paul Taylor • July 26, 2019 -
Baxter predicts pouring $500M into US renal care expansion
Potential increased demand for peritoneal dialysis technologies amid a federal push for at-home kidney care drove optimism, as did rising revenues in the medication delivery business after several quarters of disappointing growth.
By Maria Rachal • July 25, 2019 -
Verb Surgical names CEO to shepherd J&J, Verily digital surgery partnership
The startup tapped medtech vet Kurt Azarbarzin as president and CEO Wednesday. He'll be tasked with leading Verb's digital surgery platform toward commercialization.
By David Lim • July 25, 2019 -
Recalled heart balloon pumps linked to 5 patient deaths
Problems have dogged the products, which shut down while running on battery and had design flaws that allowed fluid to seep into the devices.
By Dana Elfin • July 25, 2019 -
DOJ alleges spine maker paid $7M to surgeons in kickbacks
According to the lawsuit, privately held Life Spine failed to report some of the $7 million it paid to surgeons from 2012 to 2018.
By Nick Paul Taylor • July 25, 2019 -
Varian raises sales outlook after oncology devices fuel growth
Although the company raised its full-year sales outlook, there were financial weak spots, including a slowdown in oncology orders and a big drop in sales in its proton business.
By Nick Paul Taylor • July 25, 2019 -
Edwards discontinues Centera valve, goes all in on Sapien 3 TAVR line
Executives said the company anticipates FDA will approve the transcatheter aortic valve replacement product for patients with low surgical risk during the third quarter.
By David Lim • July 24, 2019 -
Asia, structural heart central to Boston Scientific's second half strategy
Japan is slated to be a key market in the back half of 2019, with orders for drug-eluting stents appearing unaffected by FDA's paclitaxel doubts, and Watchman set to launch in September.
By Maria Rachal • July 24, 2019 -
FDA directly links Allergan Biocell breast implants with cancer risk, prompting recall
"FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women's health," Principal Deputy Commissioner Amy Abernethy wrote Wednesday regarding Allergan's Biocell textured devices.
By Nick Paul Taylor • July 24, 2019 -
Titan Medical warns robotic surgery filing target may slip
The Canadian medtech called the regulatory filing schedule "very tight" and "not completely within [its] control."
By Nick Paul Taylor • July 24, 2019 -
FDA grants first cochlear implant indication for asymmetric hearing loss
Austrian company MED-EL said its Synchrony implants won new indications for both asymmetric hearing loss and single-sided deafness in patients age 5 and older without any required changes to the approved devices.
By Susan Kelly • July 23, 2019 -
Jacob Bell/MedTech Dive
FDA sets final guidance on combo product safety reporting
The agency aims to provide clarity on new recordkeeping rules as more medical products combining devices and drugs are hitting the market.
By Susan Kelly • July 23, 2019 -
HHS-backed treatment for mustard gas injuries gains clearance
The new indication for Argentum Medical's burn and wound dressing came with help from the Biomedical Advanced Research and Development Authority.
By Nick Paul Taylor • July 23, 2019 -
Burst balloons prompt safety alert on Edwards Sapien 3 Ultra valve system
The problem is linked to issues with inflation of the valve-delivery system and follows the company's recent recall of its IntraClude intra-aortic occlusion device due to balloon ruptures.
By Susan Kelly • July 22, 2019 -
Intuitive sees bump to Q2 leasing revenues
Rising da Vinci revenues helped drive the robotic surgery technologies maker to a $1.1 billion quarter, surpassing Wall Street expectations.
By Maria Rachal • July 19, 2019 -
Pear files insomnia and depression software as Pre-Cert pilot 510(k)
CEO Corey McCann told MedTech Dive he hopes the digital therapeutic will be cleared in the first half of 2020, but cautioned Pear has "a good deal of learning to do in terms of the FDA response to this specific submission."
By David Lim • July 19, 2019 -
Jacob Bell/MedTech Dive
Opinion
Medical device corrections, removals and recalls: Where are we now?
Companies must balance maintaining a credible relationship with FDA while resisting actions that may not ultimately be in the best interests of patient safety, write Hogan Lovells' Jodi Scott and Wil Henderson.
By Jodi Scott and Wil Henderson • July 19, 2019 -
Breast reconstruction device manufacturer files for bankruptcy
AirXpanders, which won a De Novo clearance in 2016 for its carbon dioxide gas controlled tissue expander, filed for Chapter 7 bankruptcy in the Northern District of California Wednesday.
By Maria Rachal • Updated July 26, 2019 -
Sterigenics strikes deal to reopen Willowbrook sterilization plant
The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical.
By David Lim • Updated Sept. 9, 2019
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