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

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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

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

CDRH targets hiring, novel approvals among 2022-2025 strategic priorities

FDA's Center for Devices and Radiological Health, whose staff continues to struggle with an unprecedented workload since the pandemic's start, is aiming to achieve at least 90% of its annual hiring targets for certain years.

By Nick Paul Taylor • Feb. 4, 2022

BD's Q1 revenue beats Street despite COVID-19 testing decline

In spite of the pandemic and macroeconomic challenges, CEO Tom Polen said the company has "confidence" to raise 2022 revenue guidance "while remaining appropriately prudent, given the current uncertain environment." 

By Greg Slabodkin • Feb. 3, 2022

Thermo Fisher, Hologic plan for extended test demand in 2022

In a year of ups and downs for COVID-19 testing, both companies are raising revenue guidance for 2022 as the need for diagnostics isn't fading.

By Elise Reuter • Feb. 3, 2022

Siemens Healthineers ups 2022 forecast after COVID-19 test boom, but sees increased competition

CFO Jochen Schmitz told investors Thursday that as competition in the diagnostics space heats up this year, the company expects "revenues to decline sharply in the second half."

By Nick Paul Taylor • Feb. 3, 2022

Boston Scientific posts 15% gain in Q4 sales, expects 'headwinds' in 2022

CEO Mike Mahoney told investors Wednesday that omicron and near-term macroeconomic challenges will continue to put financial pressure on the medtech in the first quarter and at least through the first half of this year.  

By Greg Slabodkin • Feb. 2, 2022

Edwards-backed Corvia fails pivotal heart failure trial but clings to subgroup efficacy signal

Corvia Medical's atrial shunt therapy has failed to improve cardiovascular disease outcomes in heart failure patients, according to clinical trial results. 

By Nick Paul Taylor • Feb. 2, 2022

Breakthrough device program 'far exceeding' FDA expectations after record year

The total number of products granted the agency's regulatory privileges in 2021 increased by more than 50%, while the number of novel devices that came to market fell compared to 2020.

By Nick Paul Taylor • Feb. 1, 2022

3 key FDA topics for medtechs in 2022

While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

By Ricky Zipp , Greg Slabodkin • Feb. 1, 2022

Roundup: Latest earnings show medtechs grappling with healthcare staffing shortages, supply chain

Medical device companies ended 2021 on an "uninspiring" note, J.P. Morgan analysts said, as they brace for a slowdown in procedures driven by a surge in COVID-19 cases due to the omicron variant.

By Elise Reuter • Jan. 31, 2022

FDA must improve medical device interoperability through data standards: JAMA

The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case.

By Nick Paul Taylor • Jan. 31, 2022

Senators urge FDA to finalize over-the-counter hearing aid rule

Sen. Elizabeth Warren, D-Mass., and Sen. Chuck Grassley, R-Iowa, are asking the FDA to finalize a rule that would create a class of over-the-counter hearing aids, without implementing changes suggested by manufacturers. 

By Nick Paul Taylor • Updated Feb. 9, 2022

Edwards sees hospital capacity slow TAVR procedures, keeps 2022 guidance

The latest surge in COVID-19 cases dealt a blow to the company’s fourth-quarter revenue, but Edwards is still keeping its forecast for 2022 as it expects procedures to gradually recover. 

By Elise Reuter • Jan. 27, 2022