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

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

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

Califf's confirmation comes as FDA, medtechs skirmish over regulations

Industry groups, including AdvaMed, congratulated Robert Califf on his confirmation as FDA commissioner. But they're still negotiating with the agency over medical device user fees and lab-developed tests.

By Jonathan Gardner • Updated Feb. 16, 2022

Latest Essure data show more patients had device removed

According to the latest results from two FDA postmarket studies, the number of people who had the birth control implant removed or experienced chronic pain increased. 

By Nick Paul Taylor • Feb. 15, 2022

Inflationary risk 'manageable' for medtechs, but impact will vary: RBC

Companies like Stryker and Zimmer Biomet, with portfolios dominated by more "commoditized" products such as traditional hip, knee and spine devices, will find it hard to pass on rising costs to customers.

By Nick Paul Taylor • Feb. 15, 2022

Senseonics glucose monitor approval overshadowed by 'eye popping' fall in sales forecast

"Some change was expected given COVID delays, though we struggle to understand why the guide assumes zero growth at the low-end, particularly with a brand-new product approved," Craig-Hallum analysts wrote.

By Nick Paul Taylor • Feb. 14, 2022

Dexcom's G7 gains CE mark after 2021 delay

The company’s newest continuous glucose monitoring system was expected to launch in Europe in 2021, but regulatory delays pushed the release back.

By Ricky Zipp • Updated March 14, 2022

J&J's DePuy Synthes buys ortho company CrossRoads Extremity Systems

The deal, for an undisclosed amount, comes just weeks after Johnson & Johnson executives said the company will have a more aggressive M&A strategy going forward for the pharmaceutical and medical devices businesses.

By Ricky Zipp • Feb. 10, 2022

FDA plan to harmonize device quality system rules clears OMB review

The White House's Office of Management and Budget review positions FDA to publish a long-awaited proposed rule that is intended to bring the agency's quality system rules in line with international standards.

By Nick Paul Taylor • Feb. 10, 2022

Healthcare staffing shortages a 'rising concern' for medtechs: Moody's

In a recent quarterly report, Moody's Investors Service called out hospital labor shortages as having a potential material impact on procedures in 2022, even as the omicron surge begins to decline.

By Elise Reuter • Feb. 9, 2022

BioCardia, Cook Medical land FDA breakthrough nods in latest designations

Cardiovascular devices feature prominently in the tech granted regulatory privileges, including a drug-eluting stent for patients with chronic limb-threatening ischemia and a non-invasive cardiac monitoring device. 

By Nick Paul Taylor • Feb. 9, 2022

Robots cushion omicron's blow to Q4 orthopaedic device sales

Zimmer Biomet, Stryker and Johnson & Johnson's businesses endured more pressures tied to the postponement of elective procedures in the fourth quarter, but sales of their robotic systems continued to expand.

By Susan Kelly • Feb. 8, 2022

Zimmer gives investors first look at its dental and spine spinoff

The new, independent company, called ZimVie, is expected to bring in about $1 billion in revenue this year. While the dental unit is expected to grow immediately, the spine unit is projected to drop initially.

By Ricky Zipp • Feb. 8, 2022

Abiomed posts record revenues despite COVID-19 waves bookending the quarter

After the company reported $261 million in revenue, BTIG analysts called the update "an encouraging report during a tough earnings season." However, Abiomed's stock still fell by nearly 6% Thursday following the investor call.

By Nick Paul Taylor • Feb. 4, 2022

Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022

As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another challenging year.

Feb. 4, 2022