Third-party software vulnerability could endanger medical devices, FDA and DHS warn

The alerts expand the list of vendors whose operating systems could be exploited due to vulnerabilities known as URGENT/11. Medical devices affected include an infusion pump and an anesthesia machine, FDA said Tuesday.

By Susan Kelly • Oct. 2, 2019

Researchers automate EHR analysis for postmarket safety surveillance

Stanford researchers found an automated system extracted the vast majority of reports of complications and pain in electronic health records for hip replacement patients.

By Nick Paul Taylor • Oct. 2, 2019

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Medical 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

Stryker inks Conformis deal to develop custom knee surgery instruments

The deal could give Stryker technology to rival devices used by Johnson & Johnson, Smith & Nephew and Zimmer Biomet.

By Nick Paul Taylor • Oct. 2, 2019

Robotics, navigation systems create buzz at spine meeting

Medtronic, NuVasive and Globus Medical showed off robotic applications at the North American Spine Society gathering in Chicago. "[A]doption of more advanced platforms is not an if, but a when," Jefferies analysts wrote.

By Susan Kelly • Oct. 1, 2019

Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities

The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."

By David Lim • Sept. 30, 2019

Edwards shows improved quality of life, durability of TAVR systems in trio of studies

Among other data presented over the weekend at TCT, Boston Scientific's in-development Acurate Neo TAVR system failed to meet a non-inferiority goal on safety and efficacy when compared to Edwards' Sapien 3.

By Susan Kelly • Sept. 30, 2019

Abbott's MitraClip outperforms medical therapy in study at 3 years

In addition, a group of patients that began the study on medical therapy and crossed over to the MitraClip at two years saw benefits matching those who received the device from the start.

By Susan Kelly • Sept. 30, 2019

Implanted metal devices, dental amalgam to go under FDA's microscope

Citing the "growing body of evidence" suggesting some patients have inflammatory reactions and tissue changes to metal-containing implants, the agency announced a November advisory panel to discuss the topic.

By Maria Rachal • Sept. 30, 2019

Australia enforces new regs on all breast implant makers, suspends some devices

Even with Allergan's most controversial implants off the market, regulators opted to remove about 13% of Australia's available breast implant supply and enact new communication requirements on all remaining sellers.

By Maria Rachal • Sept. 27, 2019

Medtronic, Boston Scientific share data on stents with short-course antiplatelet therapy

The clinical trials provide data supporting the use of shorter regimens in coronary stent patients.

By Nick Paul Taylor • Sept. 27, 2019

TÜV Rheinland designated as notified body under MDR

The approval by European authorities gives medical device companies another entity to turn to as they scramble to get ready for the 2020 implementation.

By Nick Paul Taylor • Sept. 27, 2019

FDA revises clinical decision support software draft after industry blowback

The decision to revise the draft guidance comes after feedback on the 2017 version asked the agency to reconsider its approach, Bakul Patel, FDA's director for digital health, told MedTech Dive.

By David Lim • Sept. 26, 2019

BD picks new CEO

COO Thomas Polen, who led the major acquisitions of C.R. Bard and CareFusion, will replace retiring chief executive of eight years Vincent Forlenza on Jan. 28, 2020.

By Maria Rachal • Sept. 26, 2019

Device chief says FDA could be open to making breakthrough designations public

The number of breakthrough designations has doubled every year since the program's 2016 inception, and "you're going to start seeing this [number of approvals] steamroll," FDA's Jeff Shuren said at The MedTech Conference.

By Dana Elfin • Sept. 26, 2019

Boston Scientific and Medtronic devices match on safety in 3-year TAVR trial

The Boston Scientific-backed trial found a similar rate of all-cause mortality between the two systems. Boston's device beat Medtronic's on rate of disabling stroke, but had more patients receiving a new pacemaker.

By Nick Paul Taylor • Sept. 26, 2019

FDA offers guidance on filing device applications electronically

The draft is the precursor to a series of documents that will detail the submission formats and implementation timelines for specific types of regulatory applications.

By Nick Paul Taylor • Sept. 26, 2019

EPA delays ethylene oxide sterilizer rule timeline amid industry pushback

Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published.

By David Lim • Sept. 25, 2019

Medtronic plans to answer da Vinci with rival soft tissue robot

In a first look at the system Tuesday, CEO Omar Ishrak emphasized the company's effort is one of its most invested projects ever, calling it a "game changer." Medtronic anticipates FDA clearance in about two years.

By Susan Kelly • Sept. 25, 2019

To pitch Pre-Cert to Congress, FDA builds a case first

Enforcement mechanisms and the decision of how the experimental pathway will fit into the current 510(k), De Novo and PMA routes are among the details lawmakers will need to eventually address, an agency official said.

By Kim Dixon • Sept. 25, 2019

Device makers must adapt to rise of ASCs, analysts say

Bain & Company experts predict companies may consider new business models, such as taking equity stakes in ambulatory surgery centers to drive use of their latest devices.

By Nick Paul Taylor • Sept. 25, 2019

FDA grants breakthrough status to Aurora's concussion treatment

The non-invasive device uses near-infrared light to accelerate recovery from concussion.

By Nick Paul Taylor • Sept. 25, 2019

Public health alert or legal advertising? It can be hard to tell.

AdvaMed applauded the FTC's move to send letters warning lawyers and lead generating firms over potentially unfair and deceptive ads seeking clients for personal injury suits. 

By Dana Elfin • Updated Sept. 26, 2019

AdvaMed pegs medical device tax repeal hopes on year-end legislative package

A letter Tuesday from more than 600 other stakeholder organizations urges congressional leadership to permanently repeal the tax. But Stryker CEO Kevin Lobo said Monday a multi-year suspension is the most likely scenario.

By David Lim • Sept. 24, 2019

Can you pay for docs to work on cadavers in Las Vegas? Consult the updated ethics code.

"It's a demonstration of self-regulation and gives the industry that much more credibility as the government looks at these arrangements," Matt Wetzel, senior counsel with Akin Gump, said Monday at The MedTech Conference. 

By Dana Elfin • Sept. 24, 2019

FDA tries to spur patient shaping of clinical trial design with draft guidance

"Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate," acting FDA Commissioner Ned Sharpless said in a statement.

By Nick Paul Taylor • Sept. 24, 2019