Medical Devices: Page 150
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Medtronic finalizes Titan Spine deal
The medtech giant will gain a portfolio of titanium interbody implants, bought for an undisclosed amount.
By Maria Rachal • Updated June 27, 2019 -
Philips, Medtronic team up to create image-guided atrial fibrillation device
The system will use Philips' dielectric imaging and navigation system to facilitate cryoablation without extensive X-ray imaging.
By Nick Paul Taylor • May 10, 2019 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
TransEnterix slumps after selling 1 robotic system in Q1
TransEnterix expects to sell more systems in the second quarter but investors reacted badly to the results, wiping 29% off the company's stock price.
By Nick Paul Taylor • May 10, 2019 -
Takeda sells TachoSil patch to J&J's Ethicon for $400M
TachoSil, a surgical patch to control bleeding, contributed $155 million in net sales to the Japanese drugmaker's coffers during fiscal year 2018.
By David Lim • May 9, 2019 -
BD lowers guidance as FDA paclitaxel alert dents prospects
The medtech expects sales of paclitaxel-coated balloons to fall 50% in the wake of FDA recommending against use of the devices.
By Nick Paul Taylor • May 9, 2019 -
Boston Scientific closes acquisition of spinal device in $465M deal
Vertiflex's decompression system, designed to reduce pain in patients with lumbar spinal stenosis, is the company's first acquisition of 2019.
By Maria Rachal • Updated June 12, 2019 -
FDA grants De Novo to device for cerebral aneurysms
The temporary coil embolization assist device can deliver better outcomes than stents and balloon remodeling, Israeli manufacturer Rapid Medical says.
By Nick Paul Taylor • May 9, 2019 -
FDA warns of rapid battery draining in some Medtronic pacemakers
One patient has died as a result of the issue. Removal of the implanted devices from patients is not recommended, but FDA advised physicians to consider whether elective device replacement is warranted for high-risk patients.
By Susan Kelly • May 8, 2019 -
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FDA updates imaging rules in final guidance
The agency aims to align U.S. performance standards for X-ray imaging equipment with international policy, efforts supported by industry groups, and clarify aspects of U.S. requirements for fluoroscopic equipment.
By Susan Kelly • May 8, 2019 -
Aiming to boost transplant availability, FDA advises on organ preservation devices
A final guidance document outlines how product developers can design animal studies to evaluate machine perfusion organ preservation technologies.
By Maria Rachal • May 8, 2019 -
CMS pushes back 2021 DME bidding program window to July
The Competitive Bidding Implementation Contractor released a 55-page guide and 18 additional fact sheets with instructions for the 2021 bidding round.
By David Lim • May 8, 2019 -
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FTC judge upholds unraveling of microprocessor prosthetic knee firms deal
Ottobock must sell off its recent acquisition of microprocessor prosthetic knee maker Freedom Innovations over FTC's market concentration concerns.
By Dana Elfin • Updated May 8, 2019 -
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FDA finalizes laser guidelines, rebuffing calls for harmonization
The agency acknowledged the advantages of harmonization but will continue to enforce its own standards for now.
By Nick Paul Taylor • May 8, 2019 -
Photo by Paweł Czerwiński on Unsplash
Verily's nanoparticle diagnostic program evolves into Verve partnership
Alphabet's life sciences research arm was initially interested in nanoparticle diagnostics but thinks the program has therapeutic potential.
By Nick Paul Taylor • May 8, 2019 -
Allergan breast implant sales drop more than 30% in Q1
Company executives downplayed the dent to the medical aesthetics unit to investors, noting that 70% of its breast implants are sold in the U.S., where the majority used feature a smooth surface less frequently tied to a rare cancer.
By Maria Rachal • May 7, 2019 -
ACLA, AdvaMedDx, BIO call for VALID Act movement by year-end
Despite differences between clinical labs and diagnostic manufacturers, industry wants to keep the legislation at the top of mind for Congress before the election and user fee negotiations suck oxygen away from the effort next year.
By David Lim • May 7, 2019 -
Test for circulating tumor DNA wins FDA breakthrough designation
Genetic testing company Natera is developing the product to detect and quantify post-surgery ctDNA in the blood of patients already diagnosed with some types of cancer.
By Susan Kelly • May 7, 2019 -
Jacob Bell / BioPharma Dive
FDA issues final guide on device submission meetings, feedback
The agency also announced it will hold a webinar on June 11 to discuss the Q-Submission program.
By Susan Kelly • May 7, 2019 -
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Diabetes tech companies share beat-and-raise start to 2019
Despite growing competition from larger medtechs, Dexcom, Insulet and Tandem all boosted revenue targets for the year on significant expansion of insulin delivery systems and continuous glucose monitors in the first quarter.
By Maria Rachal • May 6, 2019 -
Stanford University
Test for gene fusions in tumors gains breakthrough status
The assay from Caris Life Sciences is intended to detect fibroblast growth factor receptor biomarkers, including gene fusions, in solid tumors.
By Susan Kelly • May 6, 2019 -
FDA OKs Staar Surgical clinical study initiation after PMA supplement holdup
Analysts at William Blair said they expect a mid-2021 U.S. approval for the implantable lenses if the company can reach a final agreement with regulators on study design.
By Susan Kelly • Updated Aug. 28, 2019 -
EU issues device, diagnostics database requirements
The documents detail what data manufacturers will need to include in the European Database on Medical Devices for devices and in vitro diagnostics under its new regulations.
By Susan Kelly • May 6, 2019 -
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Boston Scientific wins FDA approval for Vici stent
The go-ahead creates competition for BD's Venovo stent, approved in March. Cook Medical and Medtronic are currently working to get their own versions to market.
By David Lim • May 6, 2019 -
FDA seeks info on how patients view risks and benefits of devices
One health policy analyst was skeptical of the initiative, pointing to what she characterized as industry recruitment of desperate patients willing to use insufficiently tested products.
By Dana Elfin • May 3, 2019 -
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FDA plan to limit old predicates not happening soon, 510(k) regulator says
A decision to cut off use of old predicates at a specific age would "be awful," Marjorie Shulman, the assistant director of 510(k)s at FDA, said.
By David Lim • May 3, 2019
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