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

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

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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

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

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

Diagnostics makers ride omicron surge in COVID-19 test demand. But for how long in 2022?

The highly transmissible variant caused the Biden administration to announce plans to buy 1 billion rapid tests to provide free to Americans. However, when testing will ramp back down remains an open question.  

By Greg Slabodkin • 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

Digital therapeutics face barriers to growth as Pear takes early steps toward sales targets

Among the challenges facing DTx are lack of support for rapid updates, limitations of current reimbursement policies, cybersecurity risks as well as a "pressing need" for new regulatory frameworks, according to researchers.

By Nick Paul Taylor • 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

Biden administration to buy 500M more rapid COVID-19 tests to give to Americans

The announcement by President Joe Biden now brings the administration's total purchase to 1 billion test kits. Abbott Laboratories, iHealth and Roche have so far been awarded contracts for a combined 380 million tests.

By Greg Slabodkin • Jan. 14, 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

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

Notified body shortage remains pressing as industry prepares for staggered IVDR rollout

Three months have passed since the European Commission warned about a "grave shortage of notified body capacity," but the situation is largely unchanged.

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

Biden health officials defend COVID-19 testing policies amid diagnostics shortage

Acting FDA Commissioner Janet Woodcock and others were under fire from senators during a Tuesday hearing for not doing enough to increase the availability of tests.   

By Greg Slabodkin • 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

iRhythm stock jumps nearly 28% after Novitas doubles Medicare rates for cardiac monitoring

The new rates give the cardiac monitor maker a boost following a challenging 2021. After a Monday spike, iRhythm's stock price was also up by nearly 9% when the market closed Tuesday.

By Ricky Zipp • Jan. 11, 2022

Insurers will be required to cover 8 at-home COVID-19 tests per month

After proposing the plan in December, the Biden administration on Monday detailed its plan to have insurers cover rapid tests. Health insurance lobby AHIP warned of potential "hiccups in early days" of implementation.

By Nick Paul Taylor • Jan. 11, 2022

Medtronic CEO: Company on track to hit guidance, omicron impact 'uncertain'

Geoff Martha, who spoke on the opening day of J.P. Morgan's healthcare conference, said the medtech is being impacted by both the delta and omicron variants, including ongoing pressure from hospital staffing shortages.

By Ricky Zipp • Jan. 10, 2022

FDA warning letter cites product safety issues in Medtronic diabetes group

The agency was critical of how long Medtronic took to recall certain MiniMed insulin pumps, despite over 57,000 medical device reports being filed with the FDA over more than three years.

By Ricky Zipp • Jan. 5, 2022

Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage

FDA granted emergency use authorizations to the over-the-counter diagnostics under a new accelerated review program. However, the companies may need months to scale up production.

By Nick Paul Taylor • Jan. 4, 2022

iRhythm's Medicare pricing saga defined its 2021

The cardiac monitor maker had a series of setbacks following Novitas Solutions' Medicare rate cut, including a stock free fall and a new CEO resigning after 4 months. Here's our coverage of iRhythm in 2021. 

Dec. 30, 2021

User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

Dec. 28, 2021