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

Explore the Trendline➔

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

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

FDA to regulate lab developed tests in policy reversal

HHS is withdrawing a Trump-era policy that exempted LDTs from premarket review. The American Clinical Laboratory Association warned continually shifting policies "undermines patient access to lifesaving diagnostics."

By Susan Kelly • Nov. 16, 2021

FDA questions safety of Philips replacement foam for recalled devices

The agency has asked Philips Respironics to conduct more safety testing on the sound abatement foam at the center of the sleep apnea and ventilator device recall, but did not recommend that patients stop using the machines.

By Susan Kelly • Nov. 15, 2021

FDA panel finds need for surveillance of devices from Endologix, Medtronic and others

Experts convened earlier this month by FDA warned the risks of routine use of Endologix's current endovascular graft device outweigh the benefits.

By Nick Paul Taylor • Nov. 15, 2021

Biden nominates Robert Califf to return as FDA head

If confirmed, the cardiologist would return to lead an agency taxed by a heavy COVID-19 workload and a backlog of initiatives back-burnered amid the pandemic.

By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021

After another successful quarter, diabetes tech players look ahead to key product launches

Dexcom's new G7 CGM system is expected to gain CE mark clearance in Q4, and Insulet's Omnipod 5 insulin pump is on track for FDA clearance and a limited launch by the end of the year.

By Ricky Zipp • Nov. 11, 2021

Siemens software vulnerabilities potentially put millions of medical devices at risk

A U.S. cybersecurity agency issued an alert about the vulnerabilities which could allow hackers to disrupt the operation of anesthesia machines and bedside monitors from multiple manufacturers.

By Nick Paul Taylor • Nov. 11, 2021

Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021

CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways

The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.

By Nick Paul Taylor • Updated Nov. 12, 2021