Policy & Regulation: Page 2

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

Lucira gets FDA nod for OTC molecular COVID-19 test

The emergency authorization adds to the competition with the agency clearing over-the-counter tests from Abbott and Cue Health in recent months. The $55 per kit price tag is much higher than Lucira's estimate earlier this year.

By Nick Paul Taylor • April 13, 2021

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How medtechs are navigating the sales environment after the pandemic

The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.

By MedTech Dive staff

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

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

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 at 10:41 a.m.

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

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.

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

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

Abbott, BD, Quidel tests get EUAs for asymptomatic COVID-19 serial screening

While the Abbott and Quidel authorizations are for over-the-counter use, BD's test requires a prescription, which "along with the fact an instrument is needed, limits the use-cases for the company significantly," William Blair analysts wrote.

By Greg Slabodkin • April 01, 2021

FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products

A new agency webpage features the latest information about the potential impact of viral mutations on molecular diagnostics such as Cepheid's Xpert line of rapid SARS-CoV-2 tests.

By Nick Paul Taylor • March 31, 2021

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

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

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

Boston Scientific links just approved liver cancer device to improved survival

Analysts at Evercore ISI estimate FDA clearance for the radioactive glass beads opens up a $150 million U.S. market opportunity, although they note lack of data from a randomized trial "could be a factor in modeling adoption."

By Nick Paul Taylor • March 26, 2021

Abbott, Quest, Roche among cos pitching K-12 COVID-19 test plan to tap into Biden's $10B fund

A who's who of sector companies are teaming with the Rockefeller Foundation on the proposal. The industry stands to benefit from widespread school testing as symptomatic demand diminishes.

By Nick Paul Taylor • March 26, 2021

Hospitals flailed amid COVID-19 crisis, are unsure of future, OIG says

Executives said they were worried about their workers experiencing trauma and concerned a shrinking recruitment pool for nurses could exacerbate staffing shortages.

By Ron Shinkman • March 25, 2021

Boston Scientific to pay $188.6M to settle mesh claims in 47 states

The agreement with the attorneys general settles allegations the medtech giant misrepresented or failed to disclose to patients all of the potential risks involved with the vaginal implants.

By Susan Kelly • March 24, 2021

Baxter, digital health startups lead pushback against 510(k) exemptions

Companies argued in public comments that relaxing certain FDA regulations could put consumer safety at risk. Roche was a rare supporter, arguing the changes would "free up much needed FDA resources."

By Nick Paul Taylor • March 23, 2021

AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas

A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad. 

By Ben Fidler • March 22, 2021

FDA grants EUA to COVID-19 screening device using machine learning

While the product gives institutions another screening tool for those without symptoms, Tiger Tech faces competition with antigen testing scaling up. 

By Nick Paul Taylor • March 22, 2021

EU group proposes minimum standards for rapid antibody COVID-19 tests

Antibody tests of questionable accuracy proliferated on both sides of the Atlantic early in the pandemic, leading the U.S. and European Union to try to raise standards. 

By Nick Paul Taylor • March 19, 2021