6 medtechs to watch when earnings kick off next week

First quarter results from Abbott, Edwards, Intuitive, J&J, Quest and Roche will help reveal the pace of procedure recovery and if the coronavirus testing boom has legs despite the rollout of vaccines. 

By Nick Paul Taylor • April 15, 2021

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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

HHS urged to conduct ‘vigorous oversight’ of hospital price rule after reports of noncompliance

U.S. lawmakers want the secretary to step up oversight of the new requirement for health systems to make prices for procedures like hip and knee replacements available to the public.

By Samantha Liss • April 14, 2021

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

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

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

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 9, 2021

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 9, 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 8, 2021

12 deaths linked to Class I recall for Medtronic’s HeartWare HVAD

The recall was first made public in the FDA’s database on April 6. Medtronic provided a different accounting of total patient deaths as of January and said the company is redesigning parts.

By Nick Paul Taylor • Updated April 16, 2021

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 7, 2021

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 7, 2021

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 7, 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 6, 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 5, 2021

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

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 5, 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 1, 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 1, 2021

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 1, 2021

FDA panel to probe Endologix, broader stent graft safety in November

An advisory panel will meet for two days as the agency mulls further action to address blood leak risks with the medtech’s grafts for abdominal aortic aneurysms, and surveillance strategies for all AAA endovascular grafts.  

By Susan Kelly • Updated Aug. 26, 2021

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