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

FDA grappling with influx of illegal COVID-19 tests entering US

The agency has issued a flurry of recent warnings about diagnostics that have been illegally imported into the country as the demand for at-home coronavirus testing increased with the omicron surge.

By Greg Slabodkin • March 18, 2022

What's holding up hospital at home?

Widespread adoption of acute-level care at home models has been hampered by physician reluctance and patchwork reimbursement, though a CMS waiver caused hospital participation to snowball during the pandemic.

By Rebecca Pifer • March 18, 2022

Illumina sues Guardant CEOs over trade secrets, sparking counterblast against 'retaliatory' lawsuit

Guardant called the lawsuit "frivolous and retaliatory" and framed it as a response to its concerns about the Illumina-Grail merger.

By Nick Paul Taylor • March 18, 2022

As White House warns of 'squandering' gains, AdvaMed sets out plan to sustain COVID-19 test capacity

The medtech lobby is calling for the creation of a permanent public-private diagnostic testing forum and warm-base manufacturing agreements to maintain testing capacity in the event of future surges. 

By Nick Paul Taylor • March 17, 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

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

Threats, obscenities, homicide: Healthcare workers stressed by pandemic face elevated violence

Millions of healthcare workers across the country are becoming inured to workplace violence, which can range from verbal abuse and threats to physical attacks and even homicide.

By Hailey Mensik • March 9, 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

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

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

Healthcare job gains in February far exceed recent months

Healthcare added 64,000 jobs last month, though employment in the sector is still down by about 306,000 jobs, or 1.9%, since February 2020.

By Hailey Mensik • 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

Biden discusses drug prices, mental health services in annual address

The president also announced a "test to treat" program that would allow people to receive a COVID-19 test at a pharmacy and immediately receive free antiviral pills, such as Pfizer's Paxlovid or Merck's molnupiravir.

By Shannon Muchmore • March 2, 2022

Celltrion recalls 1.2M rapid COVID-19 tests for improper labeling

The company initiated the fourth recall of its rapid COVID-19 tests in recent weeks, which the FDA designated as a Class II recall.

By Nick Paul Taylor • Updated March 9, 2022

'We have to make a stand': Biotech leaders vow to break ties with Russia over Ukraine war

Biotech CEOs Paul Hastings and Jeremy Levin explained the goals behind a letter supported by more than 400 executives and investors that calls for drugmakers to stop working with Russian companies.

By Ben Fidler , Ned Pagliarulo • Updated March 1, 2022