Senate passes legislation to avoid Medicare cuts for providers in year-end sprint

Groups like the American Hospital Association came out in support of the legislation, which would mitigate some of the cuts set to soon take effect.

By Rebecca Pifer • Updated Dec. 10, 2021

Senate passes bill to delay 2022 Medicare rate cuts for hundreds of lab tests

Senators late Thursday passed an end-of-year package that will delay the 15% cuts for nearly 600 tests slated to kick in next month. Passed by the House on Tuesday, the bill must still be signed by President Joe Biden to become law.

By Greg Slabodkin • Updated Dec. 10, 2021

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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

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

By Nick Paul Taylor • Dec. 7, 2021

Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant

The agency's list focuses on coronavirus diagnostics impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific's TaqPath test kits.

By Nick Paul Taylor • Dec. 6, 2021

Congress passes on delay to Medicare rate cuts for lab tests, for now

The American Clinical Laboratory Association wants lawmakers to push off 2022 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.

By Greg Slabodkin • Dec. 6, 2021

Insulet's Omnipod 5 insulin pump cleared by FDA after months of delays, sending shares up 9%

The clearance better positions Insulet to compete with rival Tandem Diabetes Care, and comes while Medtronic's diabetes group is managing multiple product safety problems.

By Susan Kelly , Ricky Zipp • Updated Jan. 28, 2022

Device recalls jumped 36% in Q3, first quarterly increase since 2020: report

The primary reasons for recalls in the quarter were software issues, which have been the leading causes in 21 of the last 22 quarters, according to Sedgwick's November U.S. product recall index.

By Ricky Zipp • Dec. 3, 2021

Biden orders private health insurers to cover COVID-19 home tests

Test makers such as Abbott, BD and Quidel could see demand increase as costs for consumers are reimbursable. The White House is also doubling distribution of free at-home tests to uninsured and underserved communities.

By Nick Paul Taylor • Dec. 3, 2021

NuVasive resumes US shipments of titanium-based orthopaedic devices, gets FDA thumbs up

The agency voiced its support for the reintroduction of the Precice products, telling healthcare providers that the availability of the devices is in the best interests of patients as the benefits outweigh the known risks.

By Nick Paul Taylor • Dec. 2, 2021

EU finalizes implementing regulation for Eudamed medical device database

The European Commission has provided a framework for the basic operation of the system, slated for a May 2022 launch, including how to access it, what it will do in the event of a database malfunction and IT security measures.

By Nick Paul Taylor • Dec. 2, 2021

Medical device security continues to be casualty of hospital-medtech divide

FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, experts say healthcare providers carry a much heavier load.

By Greg Slabodkin • Dec. 1, 2021

Cyber playbook sets out strategies for modeling threats to medical devices

The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety.

By Nick Paul Taylor • Dec. 1, 2021

FDA updates eSTAR ahead of expanding filing template for De Novo submissions

The platform has been available for manufacturers to voluntarily submit 510(k) submissions since September 2020. The agency will start accepting De Novo applications when a final rule takes effect early next year.

By Nick Paul Taylor • Nov. 30, 2021

BD test, others among rapid antigen kits authorized for one-time use by FDA

The agency has authorized another three over-the-counter COVID-19 antigen home tests for single use in people with symptoms, furthering the emergence of the kits as an alternative to PCR.

By Nick Paul Taylor • Nov. 29, 2021

IVDR milestone as EU expert panel delivers first opinion on a diagnostic submission

The In Vitro Diagnostic Medical Devices Regulation panel, which got off to a rocky start earlier this year, provided a glowing assessment of a test by an undisclosed company that screens plasma donor samples for hepatitis E virus.

By Nick Paul Taylor • Nov. 29, 2021

Biden admin investing $1.5B to quell healthcare staffing shortages, promote workforce equity

The funding is meant to address staffing shortages that have been exacerbated by the pandemic and impacted the entire healthcare industry, from hospitals to medical device companies.

By Hailey Mensik • Nov. 24, 2021

FDA resumes domestic surveillance inspections as omicron cases decline

The regulator has restarted the examinations, following a six-week freeze in response to the variant's surge. FDA plans to conduct foreign prioritized inspections starting in April.

By Nick Paul Taylor • Updated Feb. 7, 2022

CMS proposes smokers begin lung cancer screening at age 50 instead of 55

The agency is revisiting its national coverage determination to catch the disease at an earlier stage. Needham analysts say a larger pool of patients will drive demand for test makers Veracyte, Oncocyte and NeoGenomics.

By Susan Kelly • Nov. 22, 2021

Latest breakthrough device designations go to brain-computer interface, exo-suit

Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk. 

By Nick Paul Taylor • Nov. 22, 2021

FDA shakes up hepatitis C testing market by opening up 510(k) pathway

Lowering the barrier to the market could increase competition in spaces targeted by companies such as Abbott Laboratories and Roche. 

By Nick Paul Taylor • Nov. 22, 2021

New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

"I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

By Ricky Zipp • Nov. 19, 2021

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country. 

By Ben Fidler • Nov. 19, 2021

Medtronic leadless pacemaker flagged by FDA for safety risks

The agency said in a letter to healthcare providers that cardiac perforations associated with Medtronic's Micra device are more likely than traditional pacemakers to be associated with serious complications, such as death.

By Nick Paul Taylor • Nov. 18, 2021

30% of hospital healthcare workers remained unvaccinated as of September

Healthcare workers in children's hospitals had the highest vaccination rates, along with those working in metropolitan counties, according to the analysis of Centers for Disease Control and Prevention data.

By Hailey Mensik • Nov. 18, 2021

MCIT breakthrough device payment pathway included in Cures 2.0 bill

Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by CMS. Industry groups AdvaMed and MDMA both back the legislation.  

By Nick Paul Taylor • Nov. 17, 2021