Medical Devices: Page 146
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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 -
Explore the Trendlineâž”
Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
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 -
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
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