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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

FDA's performance against MDUFA IV decision goal falls to new low

The agency's premarket approval target is set to slump, with the current figure for fiscal 2021 sitting almost 20% below the prior full-year low. FDA warned in September it may not "make good" on some MDUFA IV commitments.

By Nick Paul Taylor • March 1, 2022

Medtech, hospitals on alert for cyberattacks after Russia's invasion of Ukraine

While cybersecurity threats to healthcare and medical devices have grown during the pandemic, the Russia-Ukraine conflict has raised the threat level, putting patient safety at risk.

By Greg Slabodkin • Feb. 28, 2022

HHS sets out plans to make medical device, diagnostics supply chains pandemic-proof

The U.S. Department of Health and Human Services wants to shore up the public health supply chain by investing in personal protective equipment, durable medical equipment and testing. 

By Nick Paul Taylor • Feb. 28, 2022

CMS code seen as major step toward reimbursement for digital therapeutics

Pear Therapeutics CEO Corey McCann said the agency's new HCPCS code for prescription digital behavioral therapy is an important milestone for getting digital therapeutics as a product category covered by more insurance plans. 

By Elise Reuter • Feb. 25, 2022

Roche's Foundation Medicine gets FDA breakthrough device nod in latest designations

Breakthrough status was granted to Foundation Medicine's test to detect molecular residual disease in early-stage cancer after curative therapy. A liquid biopsy from Datar Cancer Genetics was also given the regulatory privileges.

By Nick Paul Taylor • Feb. 25, 2022

ResMed says it can't keep up with surging demand amid Philips recall

CEO Mick Farrell said ResMed continues to struggle to meet surging demand for its respiratory devices, in part because of shortages of semiconductors and other key materials.

By Elise Reuter • Feb. 24, 2022