Medical Devices: Page 140
-
Medtronic updates Evolut TAVR system, gains FDA nod
The approval of the version designed for better delivery and sealing of the implant comes about a month after the agency authorized use of Medtronic's platform for patients considered at low mortality risk for open heart surgery.
By Susan Kelly • Sept. 23, 2019 -
EU changes for IVDs called a 'sea change,' revolutionary
The new in vitro diagnostic regulation, slated to come into effect May 2022, will for the first time subject as many as 90% of these diagnostics to review. Previously, most companies could self-certify.
By Dana Elfin • Sept. 23, 2019 -
Explore the Trendline➔
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 -
Medtechs keep shareholders happy, potentially at pipeline's expense: EY
The industry recorded its highest revenues ever within the last year, an analysis by the consultancy shows. Even as R&D spending grew 11%, those investments fell short of the proportion of cash returned to investors.
By Maria Rachal • Sept. 23, 2019 -
FDA lays out vision for device conformity testing pilot
The agency issued draft guidance proposing a program to accredit testing labs that would perform premarket evaluations for device makers to determine if a product earns a declaration of conformity.
By Susan Kelly • Sept. 23, 2019 -
US exempts X-ray components, other devices from China tariffs
Varian said certain components sourced from China for linear accelerators made in the U.S. were exempted.
By David Lim • Updated Sept. 24, 2019 -
NESTcc, ophthalmic imaging first up in FDA medical device 'collaborative communities'
Creation of these groups of manufacturers, payers, regulators, patients and health professionals is one of the device center's 2018-2020 strategic priorities.
By David Lim • Sept. 20, 2019 -
Active Implants gets FDA breakthrough status for knee implant
NUsurface is designed for patients who still suffer pain after undergoing a meniscectomy, one of the most widely performed surgical procedures.
By Nick Paul Taylor • Sept. 20, 2019 -
FDA moves to end need for predicate comparisons in some 510(k)s
Draft guidance documents detail how four types of medical devices can come to market via the newly minted Safety and Performance Based Pathway rather than through the conventional approach.
By Nick Paul Taylor • Sept. 20, 2019 -
Senate lawmakers direct CMS to boost non-opioid device reimbursement
The medical device industry is seeking congressional support to force Medicare to increase payment after CMS rejected the idea in a hospital outpatient rule proposed in August.
By David Lim • Sept. 19, 2019 -
J&J settles with West Virginia over allegations on mesh, hips
The $3.9 million settlement resolves the state attorney general's claims that Ethicon and DePuy unlawfully marketed the much-litigated surgical mesh and hip replacement devices.
By Maria Rachal • Updated May 5, 2020 -
UK shares 'responsible person' advice as no-deal Brexit looms
The update comes against a backdrop of rising concerns that Britain will leave the European Union without a deal.
By Nick Paul Taylor • Sept. 19, 2019 -
FDA outlines new path to market, mirroring breakthrough designation
The agency Wednesday morning issued draft guidance for medical devices or device-led combination products expected to "significantly improve" safety compared to existing treatments for non-life-threatening diseases.
By David Lim • Sept. 18, 2019 -
Mesh as good as hysterectomy for prolapse, 3-year NIH data suggests
The latest clinical trial outcomes appear in JAMA five months after FDA said mesh manufacturers had failed to prove adequate safety and effectiveness of the devices in patients with pelvic organ prolapse.
By Maria Rachal • Sept. 18, 2019 -
Manufacturer modifies wheelchair for off-roading, draws FDA warning
The agency warned power wheelchair maker 21st Century Scientific over offering seat modification packages with lifting, reclining and other functions not approved, and for marketing the equipment for use on rough terrain.
By Susan Kelly • Sept. 18, 2019 -
Analysts tip rise of TAVR to help Teleflex beat growth forecasts
Jefferies said Teleflex can post at least 8% growth over the next two years, compared to an official outlook of 6% to 7%.
By Nick Paul Taylor • Sept. 18, 2019 -
TAVR surgical bailout rate fuels talk of relaxing requirements
Some cardiologists argued the results suggest transcatheter aortic valve replacements can be performed by facilities that lack on-site surgical standby.
By Nick Paul Taylor • Sept. 18, 2019 -
CMS mandatory radiation oncology model should be scaled back, industry argues
The model would examine effectiveness of site-neutral episode-based payments for treatment of 17 cancer types to radiotherapy providers and suppliers in randomly selected geographic areas.
By David Lim • Sept. 17, 2019 -
Wright Medical's Cartiva woes will take time to fix: analysts
RBC Capital Markets analysts said slowing demand for Wright Medical's synthetic cartilage implant for arthritic toes is behind the sales slump.
By Susan Kelly • Sept. 17, 2019 -
Chronic bronchitis device wins breakthrough designation
The minimally invasive product from Gala Therapeutics delivers non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in patients’ lungs, making room for new normal cells to develop.
By Susan Kelly • Sept. 17, 2019 -
Zimmer Biomet's Rosa Brain recall categorized as Class I
FDA said it's aware of five complaints, one patient injury and no deaths related to a software issue with the robot-assisted neurosurgery technology.
By Susan Kelly • Updated Nov. 7, 2019 -
Establishment Labs gets IP boost ahead of pitch for breast implant market
The patent news is a positive for efforts to claim a slice of the volatile breast implant market, analysts at Cowen said.
By Nick Paul Taylor • Sept. 17, 2019 -
Moody's: Hospitals highly vulnerable to cyberattacks
Although email phishing, EHR breaches and ransomware schemes are most common, the new report also calls attention to vulnerabilities in medical technologies like insulin pumps and cardiac devices.
By Ron Shinkman • Sept. 16, 2019 -
FDA warns closure of Atlanta Sterigenics facility could impact medical device supply
Sterigenics said it aims to complete construction of technology upgrades at the plant, designed to reduce ethylene oxide emissions, by early October.
By David Lim • Sept. 16, 2019 -
Sanofi taps Abbott, Novo adds Medtronic for CGM integrations
The pharmas are expanding the range of glucose-sensing devices compatible with their connected insulin pens.
By Maria Rachal • Sept. 16, 2019 -
FDA finalizes 4 guidances to clarify 510(k) pathways
The documents spell out the agency's initiatives for improving the 510(k) premarket review pathway to promote faster access to new medical technologies.
By Susan Kelly • Sept. 13, 2019
Previous
