FDA flags risk of infection with CardioQuip heater-cooler device

The alert comes after three patients were infected with mycobacteria. All such devices on the U.S. market have now been implicated in contamination, including those made by LivaNova, Cincinnati Sub-Zero, Maquet and Terumo.

By Nick Paul Taylor • Updated Oct. 1, 2020

Medtronic to expand dialysis access position with Avenu Medical buyout

The deal is the second tuck-in acquisition this year for the medtech's peripheral vascular business and the company's sixth overall, following additions to insulin delivery, surgery and spinal cord stimulation offerings.

By Maria Rachal • Updated Sept. 30, 2020

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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

Analysis of FDA safety alerts spurs call for changes to medical device adverse event reporting

Slow implementation of UDI and NEST are among the hangups prompting JAMA Internal Medicine authors to envision a better U.S. system for tracking and identifying adverse events, including more mandatory reporting.

By Nick Paul Taylor • Sept. 30, 2020

COVID-19 spurred a medtech M&A boom this summer. Will it last?

Siemens Healthineers' CEO was rebuffed by his counterpart at Varian in January. But come May, the impact of coronavirus began to become clear. 

By Nick Paul Taylor • Sept. 30, 2020

Smith & Nephew inks $240M deal to buy orthopaedic assets from Integra

The U.K.-based medtech will gain control of a portfolio of shoulder replacement products and other devices that generated revenues of $90 million last year.

By Nick Paul Taylor • Sept. 29, 2020

FDA finalizes black box warning for breast implants

The term "breast implant illness," which one industry group decried as not used in clinical practice, appears multiple times throughout the agency's document but not in its example boxed warning.

By Susan Kelly • Updated Sept. 29, 2020

Abbott gets CE mark for latest CGM with Dexcom still in the wings

The step is the latest in the rivalry between the two big players in the continuous glucose monitoring market, which Wall Street analysts contend leaves room for both to gain.

By Maria Rachal • Sept. 28, 2020

BD to pay $60M to settle Bard pelvic mesh deceptive marketing claims

The payout is a fraction of the at least $475 million Johnson & Johnson has been ordered to pay states over the past year and a half for similar product liability cases.

By Maria Rachal • Sept. 25, 2020

FDA finalizes overhauled guidance on device conformity testing pilot

The revised outline of the program, which will allow accredited labs to carry out premarket testing of medical devices, includes an expanded explanation of what the pilot means for device manufacturers.

By Nick Paul Taylor • Sept. 25, 2020

Medtronic-Axonics sacral neuromod patent battle heats up

The Patent Trial and Appeal Board is moving forward on reviews requested by the bladder and bowel dysfunction-focused device maker taking on the medtech giant.

By Maria Rachal • Updated Sept. 24, 2020

Patient sentiment improving on elective procedures despite ongoing pandemic, survey suggests

A Needham & Company poll from this month found the time older U.S. consumers want to wait before feeling comfortable having surgeries again is shrinking compared to its August results.

By Maria Rachal • Sept. 23, 2020

Medtronic gets FDA breakthrough tag for device to prevent infections

The medtech giant has identified Tyrx as among the product lines to benefit from COVID-19.

By Nick Paul Taylor • Sept. 22, 2020

FDA De Novo OKs outpace 2019 with Spineology device, two others

A flurry of first-of-their-kind marketing authorizations comes as the agency may be receiving fewer new submissions compared to previous years, according to a MDUFA quarterly report.

By Susan Kelly • Sept. 22, 2020

Labs, diagnostics, dialysis sectors predicted to recover by year-end, but S&P cautious on device outlook

The analysts would "like to see the number of procedures stabilize, if not improve" before reconsidering predictions for the medical devices industry.

By Ron Shinkman • Sept. 21, 2020

CMS to push back radiation oncology model after industry blowback

Agency administrator Seema Verma said a six-month delay will be formalized via upcoming rulemaking because "more time is needed to prepare."

By Susan Kelly • Updated Oct. 22, 2020

Dexcom takes another step to keep CGMs in hospitals while Abbott targets athletes

By amassing early evidence in untapped populations, the companies hope to pursue lucrative new parts of the U.S. market.

By Maria Rachal • Sept. 18, 2020

Trump admin unveils final kidney care payment model

The CMS policy seeks to incentivize more at-home dialysis treatment, which could have implications for device makers including Baxter and newly public Outset Medical.

By Samantha Liss • Sept. 18, 2020

Nixed Philips, Hamilton, Vyaire ventilator contracts subject of expanding House probe

The oversight subcommittee wants to know if the HHS cancellation of "wasteful" contracts with the three medtechs included generous termination settlements involving payoffs to the companies. 

By Greg Slabodkin • Sept. 17, 2020

Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher

But the investors service warned the pace of innovation in the COVID-19 test sector may render some products obsolete and create winners and losers.

By Nick Paul Taylor • Sept. 17, 2020

Intersect ENT strikes €60 Fiagon buyout to expand in balloon sinuplasty

The takeover of the German electromagnetic surgical navigation specialist comes two months after a report that Medtronic moved to acquire Intersect.

By Nick Paul Taylor • Sept. 16, 2020

Medtronic, Stryker among CEOs weighing in on COVID-19 recovery

Execs at Boston Scientific and Edwards also presented at the Morgan Stanley Global Healthcare Conference this week, casting optimism on a year-end return to growth after springtime lows.

By Maria Rachal , Susan Kelly • Sept. 15, 2020

FDA finalizes voluntary consensus standard guidance

The final guidance offers updated advice for submitting requests for recognition in the premarket review process and explains when the agency may withdraw a previously recognized standard.

By Susan Kelly • Sept. 15, 2020

Another BD Alaris recall pegged Class I event by FDA

It's the latest in a flurry of notifications about the infusion pump line of products, which have been the subject of 18 of the high-risk recall notices since March.

By Nick Paul Taylor • Sept. 15, 2020

Abbott, Illumina, other medtechs shape guide conveying device risks to patients

The report from the public-private Medical Device Innovation Consortium is part of a larger movement by FDA to integrate the patient's voice in areas that include device design, clinical development and regulatory review.

By Susan Kelly • Sept. 14, 2020

Fitbit wins FDA clearance for EKG app

The nod brings the wearables giant up to speed with Apple and Samsung in the heart rhythm tracking arena.

By Rebecca Pifer • Sept. 14, 2020