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

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The agency issued draft guidance proposing a program to accredit testing labs that would perform premarket evaluations for device makers to determine if a product earns a declaration of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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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Draft guidance documents detail how four types of medical devices can come to market via the newly minted Safety and Performance Based Pathway rather than through the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

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

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

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

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

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

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

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

American Kidney Fund lobbies White House on charitable premium assistance

Insurers are pushing for a reexamination of policies they argue allow financially interested third parties to steer end-stage renal disease patients eligible for Medicare or Medicaid to private plans.  

By David Lim • Sept. 13, 2019

FDA awards breakthrough designation to nerve regeneration tech

Checkpoint Surgical previously said it sees an at least $1 billion opportunity in the therapeutic nerve regeneration business segment.

By Maria Rachal • Sept. 12, 2019