CDRH targets hiring, novel approvals among 2022-2025 strategic priorities

FDA's Center for Devices and Radiological Health, whose staff continues to struggle with an unprecedented workload since the pandemic's start, is aiming to achieve at least 90% of its annual hiring targets for certain years.

By Nick Paul Taylor • Feb. 4, 2022

Breakthrough device program 'far exceeding' FDA expectations after record year

The total number of products granted the agency's regulatory privileges in 2021 increased by more than 50%, while the number of novel devices that came to market fell compared to 2020.

By Nick Paul Taylor • Feb. 1, 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

3 key FDA topics for medtechs in 2022

While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

By Ricky Zipp , Greg Slabodkin • Feb. 1, 2022

FDA must improve medical device interoperability through data standards: JAMA

The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case.

By Nick Paul Taylor • Jan. 31, 2022

Senators urge FDA to finalize over-the-counter hearing aid rule

Sen. Elizabeth Warren, D-Mass., and Sen. Chuck Grassley, R-Iowa, are asking the FDA to finalize a rule that would create a class of over-the-counter hearing aids, without implementing changes suggested by manufacturers. 

By Nick Paul Taylor • Updated Feb. 9, 2022

3 key labor trends for hospitals in 2022

Hospitals are still grappling with rising turnover, widespread burnout and numerous staff calling in sick nearly two years after the pandemic began. It's unclear when it might get better — or how much worse it could get.

By Hailey Mensik • Jan. 27, 2022

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

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

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