The European Commission has caved to pressure on extending IVDR. Now what?

The EC's proposal creates a new set of timelines for the industry to meet and questions to consider — assuming it passes into law without further changes.  

By Nick Paul Taylor • Oct. 15, 2021

Boston Scientific, Sterigenics potential targets of EPA ethylene oxide reporting requirements

The agency has written to the operators of 31 medical device sterilization facilities, outlining its plans and requesting information to inform its final decision.

By Nick Paul Taylor • Oct. 14, 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

Withings gets FDA nod for AFib-detecting wearable, taking on Apple

The device, which is capable of detecting atrial fibrillation, combines an analog watch face with health features found in digital smartwatches. The French company joins Apple, Fitbit and Samsung in a crowded market.

By Nick Paul Taylor • Oct. 13, 2021

FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response

The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.

By Nick Paul Taylor • Oct. 12, 2021

European Commission adds 2 modules to delayed Eudamed database, with no follow-on timeline

Sections on UDI/device registration, and Certificates and Notified Bodies are now available for voluntary use but some features are missing.

By Nick Paul Taylor • Oct. 12, 2021

Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff

The system will hit the European market after the medtech giant unveiled it in 2019 and delayed the timeline amid the pandemic. Medtronic will take on market leader Intuitive Surgical and an upcoming product from J&J.

By Ricky Zipp • Oct. 11, 2021

FDA beefs up surgical stapler oversight after injuries, death reports

While medtechs like J&J and Medtronic backed the broad change, the final rule held firm on several contentious elements. The agency also updated labeling guidance of both staplers and staples due to patient safety risks.

By Nick Paul Taylor • Oct. 8, 2021

How Morgan Health hopes to finally move the needle on employer health costs: 5 insights from a chat with the venture's CEO

Morgan Health learned a lot from Haven, but is a different beast with better knowledge of the buy-in needed to disrupt the health benefits space, CEO Dan Mendelson told Healthcare Dive.

By Rebecca Pifer • Oct. 8, 2021

Will a software bill of materials help or hurt medical device cybersecurity?

President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.

By Greg Slabodkin • Oct. 7, 2021

Labcorp, PerkinElmer latest to target COVID-flu combo test market

FDA gave a nod to Labcorp's diagnostic, which uses a Roche test for SARS-CoV-2, influenza A and influenza B. PerkinElmer's assay also got emergency authorization for those three viruses as well as respiratory syncytial virus.  

By Greg Slabodkin • Oct. 7, 2021

FDA labels Ellume's recent COVID-19 Home Test recall Class I event

The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.

By Nick Paul Taylor • Updated Nov. 10, 2021

EU shares guide to MDR's 22 rules for classifying medical devices

If a manufacturer and notified body dispute a classification, the case may be referred to the competent authority in the country where the company has its registered place of business.

By Nick Paul Taylor • Oct. 6, 2021

Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks

The recalls have hit the medtech giant at a time when competitors Insulet and Tandem are ramping up in the insulin pump market and amid flagging sales in its diabetes unit.

By Susan Kelly • Oct. 5, 2021

FDA resists industry push to nix De Novo inspections in final rule

"The most controversial aspect was FDA's provision for ... an FDA inspection for what is tantamount to a 510(k)," noted Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green.

By Nick Paul Taylor • Oct. 5, 2021

Doctors slam surprise billing rule that details dispute resolution process

Making a health plan's "qualifying payment amount" the primary factor in independent dispute resolution arbitration will "cause large imaging cuts and reduce patient access to care," the American College of Radiology said.

By Shannon Muchmore • Oct. 5, 2021

Acon gets FDA nod for home COVID-19 test kit amid surging US demand

The diagnostics maker secured authorization for its over-the-counter antigen test amid a nationwide testing shortage. Abbott and Quidel are scaling up production but it could take months to boost output.

By Nick Paul Taylor • Oct. 5, 2021

FDA's real-world evidence push hampered by data challenges, 'million-dollar question'

While the agency wants to tap information like electronic health records and wearables to make pre- and postmarket decisions, these sources do not have the same quality controls as clinical trials. 

By Greg Slabodkin • Oct. 4, 2021

FDA hits nearly all MDUFA IV commitments despite pandemic disruptions

The main black mark in an audit was the failure to publish draft guidance on content for premarket submissions for software in a medical device.

By Nick Paul Taylor • Oct. 4, 2021

MCIT, cyber, RWE and 3 more takeaways from AdvaMed's 2021 conference

The medtech industry gathered virtually and in person for the lobby's annual conference, with topics ranging from the kill-off of the breakthrough device payment pathway to the pandemic upending CDRH's 2021 reset.

Oct. 4, 2021

Ransomware attacks put availability of medical devices at risk: FDA cyber chief

Industry reached a "watershed moment" earlier this year when a device outage caused by malware endangered patient lives, Kevin Fu, acting director of cybersecurity at CDRH said. "That was something we haven't seen before."

By Greg Slabodkin • Oct. 1, 2021

How much is too much? OIG warns about booze for doctors in medtech speaker programs

"This is a chance to take a hard look and see if it's worth it. The document may signal that some types of practices are just too risky," said Ben Wallfisch, a senior counsel with the Office of Counsel to the HHS Inspector General. 

By Kim Dixon • Oct. 1, 2021

Siemens gets FDA clearance for 'major' improvement to CT imaging

The agency hailed the device's photon-counting detectors as the "first new major technological improvement" in computed tomography imaging in a decade. Rivals like GE Healthcare may not be far behind.

By Nick Paul Taylor • Oct. 1, 2021

Bayer posts final analysis of Essure adverse events to FDA

The last report, which is based on social media posts, completes the deal the company made with the agency.

By Nick Paul Taylor • Sept. 30, 2021

MedTech Europe director warns about EU's turbulent switch to IVDR

Oliver Bisazza told the AdvaMed conference this week that while the European Union will "needlessly lose a great deal of tests" in the transition to the In Vitro Diagnostic Regulation, he is confident decision makers will "course correct."

By Nick Paul Taylor • Sept. 30, 2021

CMS defends proposal to nix MCIT pathway, medtechs hold out hope

If the bid to repeal the breakthrough payment rule is finalized, the agency's CMO committed to an alternative pathway that evaluates devices for Medicare patients potentially via clinical trials, outcome registries and real-world data.

By Greg Slabodkin • Sept. 29, 2021