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

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

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

Philips' problems grow as FDA labels expanded ventilator recall Class I event

The agency's new notice expands the company's June recall, which has grown to over 5 million affected devices. Jefferies analysts said it is "immaterial to financials but will negatively impact sentiment."  

By Nick Paul Taylor • Jan. 27, 2022

4 key trends for procedure-reliant medtechs in 2022

Medical device companies likely will face the same challenges this year that they have been dealing with since the pandemic's start, such as procedure volatility and hospital staffing shortages.

By Ricky Zipp • Jan. 27, 2022

Abbott Q4 revenue beats estimates on demand for COVID-19 tests; company warns of 2022 uncertainty

Abbott provided an initial coronavirus test sales forecast of $2.5 billion, which is expected to occur early in the year and will be updated quarterly. Evercore ISI analysts said the company's "testing assumptions seem derisked."

By Greg Slabodkin • Jan. 26, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

GE Healthcare's revenue hit by continued supply chain challenges

GE CEO Larry Culp said Tuesday that ongoing supply chain disruptions were "most acute" in healthcare and will last through at least the first half of 2022, describing the persistent problem as the worst in decades.

By Greg Slabodkin • Jan. 25, 2022

J&J's device recovery slowed by omicron surge, with impact expected over next several months

CFO Joseph Wolk said that the medtech giant expects pressure from COVID-19 and hospital staffing shortages to continue through the first half of 2022, with businesses recovering month by month.

By Ricky Zipp • Jan. 25, 2022

Medtronic gets earlier-than-expected FDA approval for pain device, raising concerns among Nevro investors

The premarket approval, which Medtronic wasn't expected to seek until 2023, positions it to compete with Nevro for a market it values at $1.8 billion.

By Nick Paul Taylor • Jan. 25, 2022

Medtech earnings season shows bumpy end to 2021 for some, bonanza for others

Procedure-dependent companies were negatively impacted to a greater or lesser degree by the surge in omicron cases in their most recent quarters, while COVID-19 test makers benefitted from the spike in demand.

By Elise Reuter • Jan. 24, 2022

Philips targets Q4 2022 end to recall as supply chain issues drag down results

The recall, which now impacts 5.2 million sleep apnea and ventilator machines, contributed to a 10% fall in comparable sales in the fourth quarter of 2021, while the increase in affected devices led Philips to up its field action provision.

By Nick Paul Taylor • Jan. 24, 2022

Intuitive shares slide 11% after company cautions about omicron hit in Q1

Intuitive’s stock fell after it reported earnings on Thursday, forecasting a slowdown in procedures to continue through early 2022. Other medical device companies also saw their stocks decline Monday.

By Elise Reuter • Updated Jan. 24, 2022

Medtronic's HawkOne recall labeled Class I, adding to medtech's product safety problems

FDA posted 10 Class I recall notices for Medtronic in 2021 and three so far this year. CEO Geoff Martha addressed the recalls and an FDA warning letter at the J.P. Morgan conference, claiming the company will increase accountability.

By Ricky Zipp • Jan. 21, 2022

Boston Scientific, Sterigenics start tracking ethylene oxide emissions under new EPA rules

Beginning this month, 29 medical device sterilization facilities must comply with EPA's Toxics Release Inventory reporting requirements for EtO, which has been determined to cause cancer in humans and damage DNA.

By Nick Paul Taylor • Jan. 21, 2022

Digital health funding jumps to new high as investors bet big on mental health startups: report

The explosive growth was driven by digital therapeutics and mental health technology, both of which saw capital inflows more than double compared to 2020, according to a new CB Insights report.

By Nick Paul Taylor • Jan. 21, 2022