FDA medical device regs, safety checks questioned by AMA ethics journal

As it's typically safer to discontinue the use of a drug than an implant, it "might be reasonable" to hold some devices to higher standards, suggests Ariel Wampler, author and plastic and reconstructive surgery physician.

By Nick Paul Taylor • Sept. 29, 2021

CDRH's 2021 'reset' shunted again as COVID-19 dominates workload

Jeff Shuren, who spoke during AdvaMed's annual conference, said the heavy coronavirus workload will lead it to miss some MDUFA IV performance metrics.

By Greg Slabodkin • Sept. 28, 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

FDA starts review after study finds Boston Scientific's Watchman is riskier in women

The agency is working with manufacturers of LAAO devices, a market fought over by Boston Scientific and Abbott, to assess other sources of data before deciding on the next steps.

By Nick Paul Taylor • Updated Sept. 29, 2021

Delta pressure on US hospitals dragged August operations, Kaufman Hall finds

"The August data show we are not out of the woods yet, and hospitals face additional uncertainties as we move into the fall and winter," said Erik Swanson, senior vice president of data and analytics for the consultant group.

By Rebecca Pifer • Sept. 28, 2021

Amid pandemic, medtech R&D, merger activity jumped: EY report

Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.

By Nick Paul Taylor • Sept. 27, 2021

Medtechs face supply chain disruptions from semiconductor shortage: report

The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.

By Nick Paul Taylor • Sept. 24, 2021

FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions

The agency's order to assess performance comes amid renewed focus on testing that's seen manufacturers add capacity and land contracts with the federal government worth more than $1 billion.

By Nick Paul Taylor • Sept. 24, 2021

FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event

The recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched.

By Nick Paul Taylor • Sept. 23, 2021

EU threatens Illumina for closing $8B Grail deal while still under review

The European Commission's warning of fines and other measures is another step in a saga that could run for years. If the bloc ultimately opposes the acquisition, the path forward will be through the courts.

By Nick Paul Taylor • Sept. 22, 2021

Paige's AI-based software gets FDA nod to help doctors identify prostate cancer

It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.

By Nick Paul Taylor • Sept. 22, 2021

Medtronic embolization device hit with another Class I recall, 2 deaths cited

The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology.

By Susan Kelly • Updated Sept. 22, 2021

Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market

The challenge for Abbott as the newcomer is to take share in a relatively mature market dominated by well-set incumbents, without evidence of superiority.

By Nick Paul Taylor • Sept. 21, 2021

UK seeks overhaul of AI, software as a medical device regs

The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.  

By Greg Slabodkin • Sept. 20, 2021

FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study

The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.

By Nick Paul Taylor • Sept. 17, 2021

FTC warns app makers fall under breach notification rule

The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.

By Shannon Muchmore • Sept. 16, 2021

FDA creates new office to drive forward digital transformation strategy

Vid Desai, who will help lead the new Office of Digital Transformation, was also named as the agency's chief information officer. FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan.

By Nick Paul Taylor • Sept. 16, 2021

CMS moves to scrap MCIT rule due to clinical evidence concerns

AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

By Nick Paul Taylor • Sept. 14, 2021

Medtechs are boosting DTC investment, but industry still years behind pharma

Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.

By Ricky Zipp • Sept. 14, 2021

MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

By Nick Paul Taylor • Sept. 13, 2021

Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push

Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.  

By Greg Slabodkin • Sept. 10, 2021

FDA ends summer with fresh batch of breakthrough device designations

Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.

By Nick Paul Taylor • Sept. 10, 2021

Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

By Nick Paul Taylor • Sept. 8, 2021

Feds sue UPMC heart surgeon for billing multiple surgeries at same time

The False Claims Act litigation also accuses the health system of ignoring or minimizing complaints by employees and staff.

By Ron Shinkman • Sept. 7, 2021

TransMedics wins FDA nod for donor heart preservation system

Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.

By Susan Kelly • Sept. 7, 2021

EU expert panel starts accepting applications to review high-risk IVDs

The incoming IVD regulation, set to go into effect next May, requires certain diagnostics be reviewed by the committee and/or tested by a reference lab.

By Nick Paul Taylor • Sept. 7, 2021