Medical Devices: Page 158
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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 -
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 -
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 -
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 -
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 -
FDA ends summary reporting, says it will not ban any breast implants
The agency laid out plans to improve the accessibility of safety information about breast implants and also announced it will make public all prior adverse event reports related to the devices within a matter of weeks.
By Maria Rachal • May 3, 2019 -
AI diagnostic tool for kidney disease earns breakthrough status
The technology uses electronic health record information and machine learning algorithms to assess blood-based biomarkers and identify patients at risk for kidney disease progression.
By Susan Kelly • May 3, 2019 -
CMS to revamp coding for new medical technology
Medical device companies will now be able to apply for a new permanent Healthcare Common Procedure Coding System code twice a year instead of annually.
By David Lim • May 3, 2019 -
Medtronic gets FDA approval for wireless pacemaker programmer
The device is the follow-up to CareLink 2090, which has been dogged by cybersecurity weaknesses.
By Nick Paul Taylor • May 3, 2019 -
Hologic posts another 'tale of two cities' quarter, analysts say
The Massachusetts-based women's health technology maker was buoyed by consistent growth in breast health and a strong showing in molecular diagnostics, but its medical aesthetics unit remains a drain.
By Maria Rachal • May 2, 2019 -
3M completes $6.7B takeout of Acelity
The deal adds new advanced wound care and specialty surgical application offerings to the Minnesota conglomerate's medical business.
By Maria Rachal • Updated Oct. 11, 2019 -
FDA launches 'super office' to link pre and postmarket review
Agency leaders said the pilot tested over the past year has yielded "significant improvements" in identifying safety issues, and industry should see benefits as well.
By David Lim • May 2, 2019 -
Abiomed misses sales target following 'confusion' caused by FDA letter
Revenue growth slowed significantly as safety concerns caused demand for protected percutaneous coronary interventions to fall.
By Nick Paul Taylor • May 2, 2019 -
Tunbridge named interim MHRA medical device chief as Wilkinson retires
Graeme Tunbridge has been with the agency since 2011 and has spent the bulk of his time working on measures to strengthen medical device regulation.
By Nick Paul Taylor • Updated Oct. 21, 2019 -
Smith & Nephew raises outlook as soaring sales in China drive growth
The first quarter performance made Smith & Nephew "increasingly confident" it will hit the upper end of its 2019 sales guidance.
By Nick Paul Taylor • May 2, 2019 -
Japanese ortho device market grows, despite steep barriers to entry
The second largest market for U.S.-made medical devices comes with unique regulatory and reimbursement hurdles.
By Meg Bryant • May 1, 2019 -
Plastic surgery device maker draws FDA warning letter
Plano, Texas-based Surgisil has been selling two of its devices for lip augmentation, an indication regulators said is not covered by the company's facial implant 510(k) clearance.
By Susan Kelly • May 1, 2019 -
DHS highlights cybersecurity weakness in Philips EMR
Hackers could exploit a vulnerability in the company's electronic medical record system to access sensitive information or execute arbitrary code, the Cybersecurity and Infrastructure Security Agency said.
By Nick Paul Taylor • May 1, 2019 -
Device to preserve donor lungs wins FDA approval
The system could expand availability of donor lungs by preserving the organ for up to five hours, giving the transplant team time to reassess marginal lungs that failed a standard initial review.
By Susan Kelly • April 30, 2019 -
CMS reopens coverage determination on next generation sequencing for cancer patients
Healthcare organizations argued the agency's original decision would prevent Medicare beneficiaries with early-stage cancer from accessing NGS tests.
By Susan Kelly • April 30, 2019 -
UK issues alert on risks with J&J surgical stapler
Days after FDA floated increasing oversight of surgical staplers, U.K. regulators flagged a warning from Ethicon that its devices' staple lines may fail.
By Susan Kelly • April 29, 2019 -
Edwards recalls two heart catheters used in infants
The devices are used to correct complex congenital heart defects after birth.
By Susan Kelly • April 29, 2019 -
Cardiology groups oppose CMS policy shift on TAVR volume
Big device players in the market have had varying comments on the proposed national coverage determination for transcatheter aortic valve replacement, which seeks to relax requirements to start a program.
By Susan Kelly • April 29, 2019 -
Legacy systems, employee error leave hospitals, devices vulnerable to cyberattacks
The challenge of guarding health systems is compounded by connected medical devices not being vetted for cybersecurity controls before joining networks, according to new research from threat detection firm Vectra.
By Meg Bryant • April 26, 2019
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