EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems

The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a leading AI role globally.

By Nick Paul Taylor • May 12, 2021

Medtronic hit with another Class I recall regarding HeartWare HVAD system

The recall for instructions and patient manuals marks the system's third Class I recall in 2021 and fifth since 2018. One death and 64 injuries have been reported due to issues from the most recent recall.

By Ricky Zipp • May 12, 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

Providers supportive of push to overhaul HIPAA, but air serious concerns about data privacy, timing

"We urge OCR to reconsider implementing a massive change to patient privacy laws in the midst of this transition," AMA commented on the Trump-era rule.

By Rebecca Pifer • May 11, 2021

OIG calls on EPA to review ethylene oxide cancer risks, possibly delaying new regulations until 2022

The Office of Inspector General wants the agency to conduct a fresh review of cancer risks from EtO emissions associated with medical device sterilization facilities. EPA's final commercial sterilizer rule had been slated for 2021.

By Susan Kelly • May 11, 2021

CMS implementation of breakthrough payment rule may be further delayed: Cowen

The agency will most likely push the start date back further to address the concerns of critics of the contentious Medicare Coverage of Innovative Technology initiative, an analyst contends.

By Nick Paul Taylor • May 10, 2021

With MDR nearing, EU updates guidance on transition to Eudamed database

The European Union no longer requires reporting obligations to be carried out as soon as the database becomes fully functional. The Medical Device Regulation takes effect May 26 and Eudamed will come online one year later.

By Nick Paul Taylor • May 7, 2021

FDA shares plan for restarting facility inspections, warns backlog will persist into 2022

In a projected base-case scenario, the agency expects to have cleared 26% of its backlog of medical product inspections by October. A total of 2,426 device and radiological health inspections remain for fiscal year 2021.

By Nick Paul Taylor • May 7, 2021

AI, digital health feature in latest batch of FDA breakthrough device designations

The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.

By Nick Paul Taylor • May 5, 2021

Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions

While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.

By Ricky Zipp • May 3, 2021

CMS finalizes joint replacement pricing extension with input from medtech industry

Cowen analysts say the agency's initiative could evolve in ways that put pressure on the prices of orthopaedic devices. However, they contend companies can mitigate that threat by selling more products to customers.

By Nick Paul Taylor • April 30, 2021

CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices

Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray and Stryker's SpineJack system are among those that would get the extension under the proposed fiscal 2022 inpatient hospital rule.

By Nick Paul Taylor • April 28, 2021

Abbott, Quest look to post-pandemic home testing beyond COVID-19

With development of at-home coronavirus tests, the companies see opportunities for over-the-counter and direct-to-consumer diagnostics for other diseases and conditions, from respiratory ailments to cancer.

By Greg Slabodkin • April 27, 2021

Hospital margins remain narrow in March as COVID-19 financial strain lingers

Pandemic-related costs continue to depress health system finances, though performance recuperated as outpatient activity increased, Kaufman Hall found.

By Rebecca Pifer • April 27, 2021

FDA greenlights device to retrain muscles in stroke patients

The noninvasive brain-computer interface technology uses data from the uninjured side of a patient's brain to recover motor function in the affected arm and hand.

By Susan Kelly • April 26, 2021

Value-based care at 'critical juncture,' new CMMI chief says

Even though some testing payment models have been delayed or discarded, the new leader of CMS' innovation arm said the agency remains committed to finding models that reward value over volume.

By Rebecca Pifer • April 23, 2021

AdvaMed pushes CMS to implement MCIT final rule without further delay

The Medicare agency postponed the proposal from taking effect amid criticism from some doctors and safety groups that it risks promoting device use without rigorous evidence of safety and effectiveness.

By Susan Kelly • April 19, 2021

FDA drops 8 medical software functions from oversight

The final rule, issued without notice or comment, brings the software classifications in line with provisions of the 21st Century Cures Act and reflects the agency's current statutory authority.

By Susan Kelly • April 19, 2021

BD files new 510(k) submission for troubled Alaris infusion pump

The announcement comes after a spate of software and hardware recalls regarding the Alaris system throughout 2020 and 2021.

By Ricky Zipp • Updated April 26, 2021

FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan

The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.

By Nick Paul Taylor • April 16, 2021

EU MDR delay has not made new rules easier to stomach: exec poll

Most of the 115 respondents to the Climedo Health survey said resources and lack of clarity were top challenges, with about a third indicating compliance efforts will cost their company 5% to 10% of annual revenue.

By Ricky Zipp • 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

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

The US paused use of J&J's vaccine. What happens next?

A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.

By Ned Pagliarulo , Ben Fidler , Jonathan Gardner • 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