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

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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

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

Baxter hit with $18M SEC penalty for accounting improprieties

The U.S. Securities and Exchange Commission settled charges and levied a penalty against Baxter "for engaging in improper intra-company foreign exchange transactions" resulting in the net income misstatement. 

By Nick Paul Taylor • Feb. 24, 2022

Diabetes tech leaders expect another year of growth, innovation as competition soars

MedTech Dive spoke with diabetes technology leaders about what to expect in 2022, the impact of new products and the increasingly competitive market.

By Ricky Zipp • Updated May 12, 2022

Smith & Nephew hires CEO from Siemens Healthineers, forecasts growth for 2022

The orthopaedics company's stock jumped 8% on the CEO news, even though its fourth-quarter revenue fell slightly short of the analyst consensus. Smith & Nephew is more optimistic about 2022 than rivals Stryker and Zimmer Biomet.

By Nick Paul Taylor • Feb. 23, 2022

What does a more aggressive M&A approach mean for J&J's devices unit?

After medical device deals took off last year, one of the industry's biggest companies could make a splash in the sector in 2022.

By Ricky Zipp , Elise Reuter • Feb. 22, 2022

FDA publishes proposed rule to align quality system requirements with international standards

The rule, which harmonizes U.S. good manufacturing practices with ISO standards, could save device companies hundreds of million of dollars by making it easier for those that comply with both standards, the agency says.

By Elise Reuter • Feb. 22, 2022

Baxter infusion pump recall labeled Class I by FDA

The recall labeling on Friday follows a safety notification issued by the agency in February, which warned that "use of the affected products may cause serious adverse events."

By Elise Reuter • Updated March 14, 2022

Medtronic's Q3 revenue misses estimates as omicron curbs procedures

CEO Geoff Martha on Tuesday told investors the COVID-19 resurgence, which peaked in the final weeks of January, curbed procedure volumes. He expects them to recover in March and April.

By Greg Slabodkin • Feb. 22, 2022

FDA calls device manufacturing expert meeting to discuss quality system harmonization

After the agency began transitioning its Quality System Regulation in 2018, the public may finally get to see the proposed rule in late February or early March.

By Nick Paul Taylor • Feb. 18, 2022

Medtronic talks diabetes group's FDA warning letter, new products, supply chain constraints

Ali Dianaty, VP of product innovation and operations for Medtronic Diabetes, spoke to MedTech Dive about the warning letter's impact on product reviews, creating insulin pump patches and navigating the pandemic.

By Ricky Zipp • Feb. 18, 2022

Baxter begins integrating Hillrom, faces supply chain pressures

The recent omicron surge put a damper on the company's margins, as shipping costs and healthcare staff shortages rose. Baxter expects these problems to abate in the short term and sees a long-term boost from the Hillrom acquisition.

By Elise Reuter • Feb. 17, 2022

EU issues guidance on high-risk IVDs, surveillance of legacy medical devices

The documents outline how notified bodies can meet In Vitro Diagnostic Medical Devices Regulation requirements to verify product batches of high-risk class D diagnostics, and manufacturer rules on quality management systems.

By Nick Paul Taylor • Feb. 17, 2022

Diagnostics M&A expected to be strong in 2022 after dealmaking took off last year

Respondents to KPMG's survey predict that deal volumes and values for the diagnostics space will jump again this year as companies are ready to spend more of their COVID-19 cash.

By Nick Paul Taylor • Feb. 16, 2022