From robots to staplers, a top 10 list of medtech safety hazards

The nonprofit ECRI identified increased use of certain devices outside of acute care settings and adoption of some technologies before safety is fully assessed as common themes in its annual ranking.

By Susan Kelly • Oct. 8, 2019

Livongo scores biggest diabetes contract yet

Investors reacted to the news of the BCBS federal employee program agreement by bumping up Livongo's shares more than 18%. 

By Nick Paul Taylor • Oct. 8, 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

Supreme Court slaps down Zimmer's request for review of $248M damages award in Stryker patent case

Zimmer Biomet exhausted its last possibility for review in the nearly nine-year-old infringement case involving a Stryker device patent, which awarded one of the highest ever amounts of enhanced damages in a patent infringement case.

By Dana Elfin • Oct. 7, 2019

Abbott pulling ahead in glucose monitoring race: UBS doc survey

The medtech giant's FreeStyle Libre device is expected to benefit from a low-cost pricing strategy and widening insurance coverage, which some doctors believe could spur price reductions across the CGM market.

By Susan Kelly • Oct. 7, 2019

Mechanical thrombectomy market poised to double: analysts

Clinical data and changes to treatment protocols support wider patient access to the technology, which could benefit device makers including Stryker, Medtronic and Penumbra, analysts at Jefferies said in a research report.

By Susan Kelly • Oct. 7, 2019

Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down

The company is "disappointed" the steroid delivery device, which it hopes to submit for premarket approval to FDA, did not prove superior on frontal sinus patency at 30 days when randomized against an uncoated balloon.

By Maria Rachal • Oct. 7, 2019

AngioDynamics buys Eximo to challenge Philips for PAD market, cutting EPS targets

AngioDynamics' acquisition of Eximo Medical for up to $66 million gives it an FDA-cleared laser treatment for peripheral artery disease.

By Nick Paul Taylor • Oct. 4, 2019

Survey finds CMS changes might slow radiation oncology purchases

One-third of physicians surveyed expect the bundled payment model to negatively affect purchasing, according to UBS analysts. Still, more than half expect to buy a new system within the next 12 months.

By Nick Paul Taylor • Oct. 4, 2019

Paclitaxel device makers roll out revised labels, fresh safety analyses

Philips and BD highlighted independent analyses published this week defending their drug-coated balloons as manufacturers update product labels acknowledging a late mortality signal in peripheral artery disease patients.

By Maria Rachal • Oct. 3, 2019

IMDRF cybersecurity guidance favors total product life cycle approach

The International Medical Device Regulators Forum's draft mirrors U.S. regulators' support for a total product life cycle strategy, but does not include a tiered approach to categorizing risk laid out by FDA last year.

By Nick Paul Taylor • Oct. 3, 2019

Some Class I devices could get 4 extra years to comply with EU MDR

The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday in advance of an expected vote on a corrigendum to amend or modify some parts of major upcoming EU regulatory changes.

By Dana Elfin • Oct. 2, 2019

DME industry pans CMS' gap-fill proposal, but agrees current system is "fundamentally flawed"

CMS' proposed framework to compare new technology to older items is not sufficiently fleshed out and isn't transparent enough, the American Association for Homecare said.

By David Lim • Oct. 2, 2019

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

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