Policy & Regulation: Page 2

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. 04, 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The main black mark in an audit was the failure to publish draft guidance on content for premarket submissions for software in a medical device.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. 04, 2021

Explore the Trendline➔

How medtechs are navigating the sales environment through the pandemic

The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.

By MedTech Dive staff

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.

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. 01, 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. 01, 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. 01, 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

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

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 at 9:44 a.m.

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 at 8:55 a.m.

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