Another Philips ventilator recall gets Class I label from the FDA

The recall began when the company discovered that some ventilators were assembled using expired adhesive, the failure of which could lead to injuries to patients. The FDA is treating the problem as a high-risk event.

By Nick Paul Taylor • March 23, 2022

FDA labels Philips 2018 field correction for ventilators a Class I recall

The company issued a field correction in 2018 for certain devices due to sound abatement foam degrading, the same issue spurring its 2021 recall of millions of devices. However, the company never notified the FDA.

By Ricky Zipp • March 22, 2022

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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

Dexcom's hospital glucose monitor leads latest FDA breakthrough designations

The regulatory privileges were granted to Dexcom after its at-home glucose monitors were allowed to be used in hospitals during the pandemic. AltPep, CardioStory, Insightec and Merit were also among the designations this month.

By Nick Paul Taylor • March 22, 2022

'On high alert': Hospitals wary of cyber threats from Russia-Ukraine war

Cybersecurity has always been chronically underfunded in hospitals, even before COVID-19 swallowed up more resources. Now, this major international threat is creating a "perfect storm," one cybersecurity expert said.

By Rebecca Pifer • March 21, 2022

US appeals court rules in favor of Nevro in patent dispute with Boston Scientific

The U.S. Court of Appeals for the Federal Circuit upheld that some of Boston Scientific's neuromodulation patent claims were not valid, notching another win for Nevro in the ongoing litigation between the two companies.

By Elise Reuter • March 21, 2022

'Not for the faint of heart': Insulet CEO talks Tandem and Medtronic competition, Omnipod 5 launch

Shacey Petrovic spoke to MedTech Dive about the long-awaited launch of its insulin pump, competitors' developing patch pumps and how the Ukraine crisis will impact the industry.

By Ricky Zipp • March 17, 2022

French, German medtech groups call for at least 2-year extension of MDR's transition period

"We are running out of time. The situation worsens dramatically. A collapse in patient care must be prevented," France's Snitem and Germany's BVMed said in a joint statement.

By Greg Slabodkin • March 17, 2022

FDA identified 28 suppliers unaware of Philips sleep device recall

The agency contacted 182 suppliers of recalled devices, and 28 said they were not aware of the recall. The FDA claims when it emailed Philips with the information, there was no response.

By Ricky Zipp • March 16, 2022

US replaces EU as priority market for medtech industry: survey

A survey of more than 100 executives at medical device companies found 89% of medtechs plan to prioritize U.S. regulatory approval going forward. One CEO said the EU's Medical Device Regulation "is killing innovation."

By Nick Paul Taylor • March 16, 2022

Steep drop in medical device reports on Bayer's Essure in 2021, FDA data show

The agency received 3,701 reports related to Essure in 2021, having received more than 30,000 reports across the two previous years. The decline comes as FDA's data show more patients had the birth control devices removed.

By Nick Paul Taylor • March 15, 2022

Apyx's surgical device gets FDA warning on off-label skin procedure use

The move by the agency follows reports of second- and third-degree burns, infection and other adverse events, some of which required treatment in an intensive care unit.

By Nick Paul Taylor • March 15, 2022

ZimVie CEO talks company spinoff, new technologies

Vafa Jamali spoke to MedTech Dive about plans for the spine and dental businesses, with revenues of roughly $1 billion forecast in 2022, and the benefits of operating as a spinoff. 

By Elise Reuter • March 14, 2022

GE Healthcare profit forecasts meet estimates; spinoff details remain cloudy

While GE's planned spinoff of its healthcare unit in early 2023 remains on track, the company said business and regional segment details, stand-alone costs and capital structure have yet to be worked out.

By Greg Slabodkin • March 11, 2022

FDA orders Philips to notify customers about sleep device recall due to 'inadequate' prior efforts

Nine months after the recall was initiated and almost one year since Philips acknowledged safety issues, the agency said its "order is necessary to eliminate the unreasonable risk of harm posed by the recalled products."

By Ricky Zipp • March 11, 2022

FDA reaches MDUFA V agreement with industry

Under the deal, the agency will receive $1.8 billion in user fees from 2023 to 2027. However, that could increase to $1.9 billion with add-on payments if the FDA's performance goals are met, according to an industry source.

By Greg Slabodkin • March 9, 2022

FDA warns of cyber vulnerabilities in medical device software components

An agency alert warned that flaws in PTC's Axeda agent and desktop server, used in devices from several manufacturers, could allow an unauthorized attacker to take full control of the host operating system.

By Greg Slabodkin • March 9, 2022

Medtronic, Nevro boosted by expansion of Medicare coverage for diabetic pain devices

Nevro, which was first to market but quickly joined by Medtronic, said around 43% of U.S. patients with painful diabetic neuropathy are now covered, up from 25% at the end of last year.  

By Nick Paul Taylor • March 9, 2022

Intuitive CEO on labor shortages, placements amid the pandemic, new competition

Gary Guthart spoke to MedTech Dive about facing new competitors Medtronic and Johnson & Johnson, and addressed criticism of the cost, safety and effectiveness of robotic surgery.

By Ricky Zipp • March 9, 2022

As ortho procedures recover, Stryker turns focus to supply chain

The medtech said that orthopaedic procedures were returning as COVID-19 cases fall in the U.S., but shortages of components and shipping continue to drive up costs.

By Elise Reuter • March 8, 2022

Medtech industry condemns Russia's invasion of Ukraine

While companies offered their support for Ukraine and those impacted by the crisis, Siemens Healthineers offered the strongest statement, calling Russia's invasion a "clear violation of international law."

By Ricky Zipp , Greg Slabodkin • March 7, 2022

Panel warns against 'knee-jerk' rejection of globalization, calls for medical supply chain transparency

Instead of onshoring device manufacturing to stabilize supply chains, a congressionally-mandated committee has recommended more transparency, including disclosing manufacturing sites for all products and components.  

By Nick Paul Taylor • March 7, 2022

FDA final guidance presses industry to be 'recall ready'

AdvaMed said the biggest concern with the earlier guidance was the potential for conflicting interpretations of whether an older regulation still applies to the initiation of recalls. The FDA has clarified the issue in the finalized guidance. 

By Nick Paul Taylor • March 4, 2022

Industry supports FDA's proposed quality system regulations, but says more time needed to adjust

"I think the potential benefit is likely to be realized very far downstream," Robert Phillips, vice president of quality and regulatory for Siemens Healthineers, said at the FDA's Wednesday meeting on QSR.

By Elise Reuter • March 3, 2022

75% of infusion pumps have cyber flaws, putting them at risk from hackers: study

An analysis of more than 200,000 infusion pumps, using crowd-sourced data supplied by healthcare organizations, found about half were susceptible to "critical" and "high" severity cybersecurity vulnerabilities.   

By Greg Slabodkin • March 3, 2022

Boston Scientific touts early results of real-world Watchman FLX study

The device, which seals off the left atrial appendage, performed similarly in the analysis to a pivotal study, with 82% of patients experiencing no leak 45 days after implant. A competing Abbott product is expected to take market share.

By Elise Reuter • March 1, 2022