Philips' problems grow as FDA labels expanded ventilator recall Class I event

The agency's new notice expands the company's June recall, which has grown to over 5 million affected devices. Jefferies analysts said it is "immaterial to financials but will negatively impact sentiment."  

By Nick Paul Taylor • Jan. 27, 2022

4 key trends for procedure-reliant medtechs in 2022

Medical device companies likely will face the same challenges this year that they have been dealing with since the pandemic's start, such as procedure volatility and hospital staffing shortages.

By Ricky Zipp • Jan. 27, 2022

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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

Abbott Q4 revenue beats estimates on demand for COVID-19 tests; company warns of 2022 uncertainty

Abbott provided an initial coronavirus test sales forecast of $2.5 billion, which is expected to occur early in the year and will be updated quarterly. Evercore ISI analysts said the company's "testing assumptions seem derisked."

By Greg Slabodkin • Jan. 26, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

GE Healthcare's revenue hit by continued supply chain challenges

GE CEO Larry Culp said Tuesday that ongoing supply chain disruptions were "most acute" in healthcare and will last through at least the first half of 2022, describing the persistent problem as the worst in decades.

By Greg Slabodkin • Jan. 25, 2022

J&J's device recovery slowed by omicron surge, with impact expected over next several months

CFO Joseph Wolk said that the medtech giant expects pressure from COVID-19 and hospital staffing shortages to continue through the first half of 2022, with businesses recovering month by month.

By Ricky Zipp • Jan. 25, 2022

Medtronic gets earlier-than-expected FDA approval for pain device, raising concerns among Nevro investors

The premarket approval, which Medtronic wasn't expected to seek until 2023, positions it to compete with Nevro for a market it values at $1.8 billion.

By Nick Paul Taylor • Jan. 25, 2022

Medtech earnings season shows bumpy end to 2021 for some, bonanza for others

Procedure-dependent companies were negatively impacted to a greater or lesser degree by the surge in omicron cases in their most recent quarters, while COVID-19 test makers benefitted from the spike in demand.

By Elise Reuter • Jan. 24, 2022

Philips targets Q4 2022 end to recall as supply chain issues drag down results

The recall, which now impacts 5.2 million sleep apnea and ventilator machines, contributed to a 10% fall in comparable sales in the fourth quarter of 2021, while the increase in affected devices led Philips to up its field action provision.

By Nick Paul Taylor • Jan. 24, 2022

Intuitive shares slide 11% after company cautions about omicron hit in Q1

Intuitive’s stock fell after it reported earnings on Thursday, forecasting a slowdown in procedures to continue through early 2022. Other medical device companies also saw their stocks decline Monday.

By Elise Reuter • Updated Jan. 24, 2022

Medtronic's HawkOne recall labeled Class I, adding to medtech's product safety problems

FDA posted 10 Class I recall notices for Medtronic in 2021 and three so far this year. CEO Geoff Martha addressed the recalls and an FDA warning letter at the J.P. Morgan conference, claiming the company will increase accountability.

By Ricky Zipp • Jan. 21, 2022

Boston Scientific, Sterigenics start tracking ethylene oxide emissions under new EPA rules

Beginning this month, 29 medical device sterilization facilities must comply with EPA's Toxics Release Inventory reporting requirements for EtO, which has been determined to cause cancer in humans and damage DNA.

By Nick Paul Taylor • Jan. 21, 2022

Digital health funding jumps to new high as investors bet big on mental health startups: report

The explosive growth was driven by digital therapeutics and mental health technology, both of which saw capital inflows more than double compared to 2020, according to a new CB Insights report.

By Nick Paul Taylor • Jan. 21, 2022

Tandem CEO on Omnipod 5 competition, pharmacy distribution, Type 2 growth

John Sheridan spoke to MedTech Dive about international growth, creating an insulin pump system for Type 2 patients and what Insulet's Omnipod 5 launch and Medtronic's FDA warning letter mean for Tandem.

By Ricky Zipp • Jan. 20, 2022

FDA misses MDUFA V deadline after months of contentious talks

The agency has failed to send the final MDUFA V user fee agreement to Congress by the Jan. 15 deadline, suggesting there may be unresolved disagreements with industry over elements of the program.

By Nick Paul Taylor • Jan. 19, 2022

CDRH pledges greater focus on women's health data

The center's strategic plan creates a framework for addressing FDA's priorities in the area of women's health, including representation in biomedical research.

By Susan Kelly • Jan. 19, 2022

Dexcom CEO on G7's global launch, COVID-19 slowing new patient adds, international growth

Kevin Sayer spoke to MedTech Dive about the upcoming launch of the G7 CGM system, further expanding Dexcom ONE and feeling pandemic pressure in the fourth quarter.

By Ricky Zipp • Jan. 18, 2022

Cybersecurity leads ECRI's list of top medtech hazards for 2022

Cyber incidents can compromise patient care and attacks against hospitals have become more prevalent in recent years. However, ECRI said the worst consequences are preventable.

By Elise Reuter • Jan. 18, 2022

FDA advises physicians to consider alternatives to Endologix AFX2 endovascular grafts

The agency said providers need to be aware that "the majority of available data" link earlier AFX endovascular graft versions to more health risks compared to similar treatments. Cook Medical and Medtronic could benefit.

By Nick Paul Taylor • Jan. 14, 2022

Medtech M&A, IPOs hit new highs as more buyers enter the space: SVB

In a new report, Silicon Valley Bank projects that medical device mergers and acquisitions "will stay hot, as a diverse set of acquirers compete for the top deals," but sees a slowdown in initial public offering activity.

By Nick Paul Taylor • Jan. 14, 2022

Intuitive's da Vinci shipments beat Q4 expectations, COVID-19 impact to last through 2022

The robotic surgery maker said during a J.P. Morgan healthcare conference presentation that it shipped a total of 1,347 da Vinci robots in 2021, a 44% increase from 2020.

By Elise Reuter • Jan. 13, 2022

Neurological devices, diagnostics dominate latest FDA breakthrough designations

The agency has granted breakthrough designations to several devices for neurological conditions, including an autism test and treatment as well as diagnosis of Parkinson's disease.

By Nick Paul Taylor • Jan. 13, 2022

Philips ups recall provisions by $250M, impacted devices to more than 5M

The Dutch medtech said the recall and supply chain issues are the primary reasons for missing fourth-quarter sales expectations by about $400 million. Philips' shares were down more than 15% early Wednesday.

By Ricky Zipp • Jan. 12, 2022

FDA seeks feedback on draft device shortage guidance

A new document poses a series of questions for industry on the overall design and operation of the policy, and is intended to help manufacturers provide timely information about supply disruptions during public health emergencies.

By Nick Paul Taylor • Jan. 12, 2022

Edwards seen falling short in Q4 based on early US TAVR volume data: Jefferies

Based on partial data for October and November, the analysts expect U.S. fourth-quarter TAVR sales to grow 7%, compared to a 14% consensus estimate.

By Nick Paul Taylor • Jan. 11, 2022