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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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

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