Medical Devices: Page 150
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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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
Most hospitals don't meet watchdog group's safe volume thresholds for high-risk surgeries
The Leapfrog Group's analysis of eight high-risk procedures at more than 2,000 hospitals included mitral valve repair and replacement.
By Susan Kelly • July 18, 2019 -
Teleflex recalls neonatal breathing devices amid gas leak risk
The company is pulling 300 of the devices from the U.S. market months after receiving FDA clearance to sell the product.
By Nick Paul Taylor • July 18, 2019 -
BD expedites fixes for faulty pumps after additional injuries
The manufacturer shared news of the hastened timeline days after the FDA categorized the recall of more than 600,000 devices as a Class I event.
By Nick Paul Taylor • July 18, 2019 -
Abbott teases FreeStyle Libre potential beyond glucose monitoring
The company is expanding manufacturing of its blockbuster diabetes device, a technology CEO Miles White said could be expanded to track other analytes.
By Maria Rachal • July 17, 2019 -
FDA warns of risks when shunt implants, hearing devices mix
Because magnetic field interference between implanted shunts and hearing devices may cause unintended changes to valve settings, the agency advises magnet-containing devices be kept a certain distance away from shunt valves.
By Susan Kelly • July 17, 2019 -
CVS launches home hemodialysis device clinical trial
The drugstore giant, which now includes insurance heavyweight Aetna, argues it can help reduce the $35 billion in Medicare costs associated with the treatment of end-stage renal disease.
By David Lim • July 17, 2019 -
Cardinal set to change CEO of struggling medical segment
The leadership change follows a trimmed profit outlook for the unit in May.
By Nick Paul Taylor • July 17, 2019 -
FDA launches innovation challenge to boost ethylene oxide sterilization alternatives
The agency also plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage innovations in medical device sterilization.
By David Lim • July 16, 2019 -
Abbott's latest MitraClip version gains FDA approval
The company has the minimally invasive mitral repair sector to itself for now, but rivals including Edwards and Boston Scientific are eyeing the space.
By Susan Kelly • July 16, 2019 -
J&J pegs new robotic surgery platforms, cementless knees as device growth drivers
The finalized divestiture of the Advanced Sterilization Products business resulted in roughly $2 billion in pre-tax gain during the quarter, which Johnson & Johnson said was offset partly by R&D investment in Auris Health.
By Maria Rachal • July 16, 2019 -
Intuitive buys Schölly's robotic endoscope business
The deal will give the robotic surgery giant control of the German company's minimally invasive visualization systems, 200 staff and three sites.
By Nick Paul Taylor • July 16, 2019
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