Medical Devices
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Jacob Bell
FDA authorizes labs for device conformity testing pilot
The accredited laboratories will assess whether medical devices meet consensus standards. None of the initial 53 labs, which include TÜV SÜD and UL, have so far received accreditation for biocompatibility testing.
By Nick Paul Taylor • April 14, 2021 -
Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll
The survey of more than 1,600 industry professionals from Emergo by UL also found respondents are most bullish on tapping Asian markets.
By Nick Paul Taylor • April 14, 2021 -
Explore the Trendline➔
Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
TrendlineThe MedTech Dive Outlook on 2021
The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.
By MedTech Dive staff -
Permission granted by iRhythm
iRhythm's future hazy after Medicare pricing saga erases 12-month high
Wall Street analysts project the cardiac wearables maker to lose tens of millions of dollars in revenue in coming years, raising questions about the future of the once-hyped market leader.
By Ricky Zipp • April 13, 2021 -
Doubts cast on CPAP efficacy evidence in HHS agency review
A report prepared for the Agency for Healthcare Research and Quality found available studies "mostly" do not support a link between continuous positive airway pressure therapy and long-term, clinically important outcomes.
By Nick Paul Taylor • April 13, 2021 -
Getty
Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance
The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions.
By Greg Slabodkin • April 12, 2021 -
Permission granted by iRhythm
iRhythm shares tank after Medicare rates surprise
CEO Michael Coyle said the wearables company will withdraw its Zio XT cardiac monitor from Medicare fee-for-service segments, adding that he was not optimistic for a reversal.
By Ricky Zipp • April 12, 2021 -
FDA puts Medtronic Valiant Navion stent graft recall in Class I category
The action, which comes amid one patient death in a clinical trial, deprives Medtronic of a source of sales growth. After securing 2018 approval, then-CEO Omar Ishrak talked up the device's potential to drive incremental growth.
By Nick Paul Taylor • April 12, 2021 -
Getty Images
Orthopaedic surgeons see slow volume recovery from COVID-19, tip Stryker to gain in poll
The 200 U.S. physicians surveyed by UBS analysts expect the medtech to pick up share in knees and hips but are downbeat on the prospects of Smith & Nephew in both of the segments.
By Nick Paul Taylor • April 09, 2021 -
Deep Dive
Medtronic's robotic spine market lead threatened as smaller rivals look to edge in
Medtronic and Globus Medical are currently in a "two pony race" in the space, but market share can be stolen as other companies launch systems and adoption grows.
By Ricky Zipp • April 09, 2021 -
MDMA, surgeons push Medicare to pull back prior authorization rules
The medtech lobby and 39 stakeholders warned CMS that including cervical fusion with disc removal and implanted spinal neurostimulators as new service categories will delay patient access to medically necessary procedures.
By Greg Slabodkin • April 08, 2021 -
Deaths trigger new Class I recall for 6 Medtronic HeartWare products
FDA has now categorized 13 HeartWare products recalled as Class I events in the past 13 months amid a stream of fault reports that have been implicated in the deaths.
By Nick Paul Taylor • UPDATED: April 8, 2021 at 4:36 p.m. -
Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says
The court ruled the case can go forward on the question of whether the medtech defrauded the agency to gain 510(k) clearance for several products by failing to disclose the devices were intended for use in cervical spine.
By Susan Kelly • April 07, 2021 -
Permission granted by IQVIA
FDA-medtech consortium offers strategy to boost patient engagement in clinical trials
The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design.
By Nick Paul Taylor • April 07, 2021 -
Getty Images
Nevro shares full diabetic neuropathy SCS data as it pursues blockbuster opportunity
If successful, the company would be the only FDA-approved spinal cord stimulation device with an on-label indication for painful diabetic neuropathy. Nevro estimates a market worth up to $5 billion, but analysts are skeptical.
By Nick Paul Taylor • April 07, 2021 -
Medtechs top pharma in cash to doctors for consulting, travel: Health Affairs study
The majority of sector payments, also covering royalties, speaking fees and food, came from the likes of Medtronic, J&J, Zimmer, Stryker and Abbott. Specialties targeted included neurosurgery, orthopaedics and cardiology.
By Ricky Zipp • April 06, 2021 -
UCLA engineer calls for mitigation of biases of medical devices
The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.
By Nick Paul Taylor • April 05, 2021 -
Jacob Bell / BioPharma Dive
FDA warns of patient deaths tied to reusable urological endoscopes
The agency is sounding the alarm after receiving more than 450 adverse event reports in four years tying patient infections to the devices. Products from Olympus and Karl Storz were cited in the reports.
By Susan Kelly • UPDATED: April 5, 2021 at 1:30 p.m. -
Jacob Bell
Liquid biopsies dominate FDA's latest breakthrough device nods
Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.
By Nick Paul Taylor • April 05, 2021 -
Medtronic inks value-based care pact with Spectrum Health
The risk-based deal, initially focused on cardiac resynchronization therapy, will have the medtech giant paying the provider if certain patient metrics are not met, according to a spokesperson for the health system.
By Nick Paul Taylor • April 01, 2021 -
FDA links certain breast reconstruction devices to risk of complications
The analysis found Becton Dickinson's AlloMax and MTF's FlexHD may have higher major complication rates than devices made by companies including AbbVie's Allergan.
By Nick Paul Taylor • April 01, 2021 -
Courtesy of Quest Diagnostics
Quest sells minority share of Q2 Solutions for $760M
IQVIA, which previously owned 60% of Q2 Solutions, will now become the sole owner of the clinical trials laboratory company. Quest and IQVIA established Q2 Solutions as a joint venture in 2015.
By Ricky Zipp • April 01, 2021 -
Maria Rachal
FDA panel to probe Endologix, broader stent graft safety in Q4
The agency is mulling further action to address blood leak risks with the medtech's grafts for abdominal aortic aneurysms and surveillance strategies for all AAA endovascular grafts. Medtronic and Cook also sell the products.
By Susan Kelly • March 30, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts.
Two Wall Street reviews suggest people are visiting hospitals more and are increasingly comfortable with undergoing elective care, but they come amid the CDC chief's warning that rising hospitalizations may jeopardize progress.
By Nick Paul Taylor • March 30, 2021 -
Getty Images
Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis
The non-implantable device delivers neuromuscular stimulation to an MS patient's tongue, sending electrical signals to the central nervous system as a short-term treatment of gait deficit.
By Nick Paul Taylor • March 29, 2021 -
Getty Images
Medtronic's Harmony pulmonary valve wins FDA approval
The device is the first non-surgical heart valve cleared in the U.S. to treat a severe form of pulmonary valve regurgitation that usually results from a congenital heart defect.
By Susan Kelly • March 29, 2021
