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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.
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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.
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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.
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Courtesy of Intuitive Surgical
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.
Updated Jan. 24, 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.
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Justin Sullivan via Getty Images
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.
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Permission granted by Roy Mendiola
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.
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Permission granted by Tandem Diabetes Care
Q&ATandem 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.
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Dollar Photo Club
Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests
A study found Exact's second-generation stool test has a lower false positive rate than the current product and is better at detecting precancerous lesions. But it is facing competing blood tests from Freenome and Guardant Health.
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Sarah Silbiger via Getty Images
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.
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Sarah Silbiger via Getty Images
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.
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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.
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Permission granted by Dexcom
Q&ADexcom 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.
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JuSun via Getty Images
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.
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Abbott
Abbott, BD, Quidel pursue DTC strategies amid 'paradigm shift' for at-home, self-testing
The three test makers said at last week's J.P. Morgan healthcare conference that they see opportunities for direct-to-consumer, digitally-connected testing for other diseases beyond COVID-19.
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WhiteHouse.gov
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.
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choness via Getty Images
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.
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Sarah Silbiger via Getty Images
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.
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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.
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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.
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Sarah Silbiger via Getty Images
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.
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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.
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Win McNamee via Getty Images
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.
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Getty Images
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.
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Nic Antaya via Getty Images
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.
