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

Explore the Trendline➔

Medical 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

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

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

EU sets out requirements for MDR expert panel members

Notified bodies must consult with the panels before clearing certain high-risk devices for marketing.

By Nick Paul Taylor • Sept. 12, 2019

Brexit threatens UK robotic surgery innovation, study finds

The Imperial College London analysis indicates a hard split from the EU could cause the U.K. to lose collaborations with other member states.

By Nick Paul Taylor • Sept. 12, 2019

China exempts certain radiation devices from tariffs, giving boost to Varian

Varian Medical Systems took a $15 million hit from the tariffs last quarter, but could now recoup taxes it paid.

By Nick Paul Taylor • Sept. 12, 2019

Baxter puts up $230M for noninvasive fluid monitor company

The medtech said it intends to incorporate Cheetah's technology, alongside its IV infusion pumps, IV fluids and medications, into a new integrated platform for patient monitoring now in development.

By Susan Kelly • Sept. 11, 2019

Abbott says AI technology can help diagnose heart attacks

A study in the journal Circulation concluded the algorithm, which aims to individualize testing by taking into account factors such as patient age and sex, performed better than the European Society of Cardiology rule-out pathway.

By Susan Kelly • Sept. 11, 2019

US needs cyber-savvy doctors as connected device use rises, FDA panel says

Patients deserve cybersecurity training as part of the informed consent process, but healthcare providers aren't well-equipped to offer it, an FDA advisory committee said Tuesday. 

By Maria Rachal • Sept. 11, 2019

Notified body BSI certifies 1st device under EU MDR

The new law will require a plethora of products that formerly didn't need certification by a notified body to undergo review. 

By Dana Elfin • Sept. 11, 2019

Physicians push FDA to shed light on device comparators

In a paper published in JAMA Network Open on Wednesday, physicians analyzed evidence used in the authorizations of products under the Humanitarian Device Exemption pathway.

By Nick Paul Taylor • Sept. 11, 2019

EBR gets FDA breakthrough tag for wireless cardiac pacing system

The device is designed to synchronize the left and right ventricles without subjecting patients to lead implantation.

By Nick Paul Taylor • Sept. 11, 2019

FDA looks to define 'triggers' for medical device cybersecurity warnings

When do the benefits of notifying patients of potential risks outweigh possible harms? The agency's Patient Engagement Advisory Committee is weighing in Tuesday.

By Maria Rachal • Sept. 10, 2019

Medtronic MiniMed insulin pump gains German reimbursement

Medtronic is counting on strong international demand for the hybrid closed loop system to maintain momentum in its diabetes business as U.S. growth slows.

By Susan Kelly • Sept. 10, 2019