FDA seeks feedback on draft device shortage guidance

A new document poses a series of questions for industry on the overall design and operation of the policy, and is intended to help manufacturers provide timely information about supply disruptions during public health emergencies.

By Nick Paul Taylor • Jan. 12, 2022

Edwards seen falling short in Q4 based on early US TAVR volume data: Jefferies

Based on partial data for October and November, the analysts expect U.S. fourth-quarter TAVR sales to grow 7%, compared to a 14% consensus estimate.

By Nick Paul Taylor • Jan. 11, 2022

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

iRhythm stock jumps nearly 28% after Novitas doubles Medicare rates for cardiac monitoring

The new rates give the cardiac monitor maker a boost following a challenging 2021. After a Monday spike, iRhythm's stock price was also up by nearly 9% when the market closed Tuesday.

By Ricky Zipp • Jan. 11, 2022

Hologic tops guidance as COVID-19 testing wave delivers another beat

The test maker said it will comfortably beat first-quarter guidance, with demand for coronavirus diagnostics helping the company post preliminary revenues of almost $1.5 billion. Quidel set the tone last week with its own beat. 

By Nick Paul Taylor • Jan. 10, 2022

Medtronic CEO: Company on track to hit guidance, omicron impact 'uncertain'

Geoff Martha, who spoke on the opening day of J.P. Morgan's healthcare conference, said the medtech is being impacted by both the delta and omicron variants, including ongoing pressure from hospital staffing shortages.

By Ricky Zipp • Jan. 10, 2022

Abbott targets consumer health, aims to turn diabetes success into wearable growth driver

The company is making a play for the wearables market with a line of patches that track the levels of biomarkers such as glucose, ketones and lactate. Abbott's push into the consumer space is part of a broader trend in medtech.

By Nick Paul Taylor • Jan. 7, 2022

Wall Street backs Stryker-Vocera strategic fit but split on valuation

The nearly $3 billion buy values Vocera at about 11.5 times higher than expected 2022 revenue, leading some analysts to question the overall price.

By Ricky Zipp • Updated Jan. 7, 2022

FDA warning letter cites product safety issues in Medtronic diabetes group

The agency was critical of how long Medtronic took to recall certain MiniMed insulin pumps, despite over 57,000 medical device reports being filed with the FDA over more than three years.

By Ricky Zipp • Jan. 5, 2022

Medtechs brace for hit as hospitals warn of omicron impact on surgeries

Healthcare staff shortages and rising COVID-19 admissions are forcing hospitals to cancel elective surgeries and postpone diagnostic and imaging procedures. BTIG sees as much as a 7% revenue hit for exposed companies.

By Nick Paul Taylor • Jan. 5, 2022

Medtech's biggest deals in 2021 and what to expect next

After dealmaking took off last year following a 2020 lull, market watchers anticipate robust M&A ahead in 2022 as companies pursue faster growth and greater scale. 

By Susan Kelly • Jan. 4, 2022

iRhythm's Medicare pricing saga defined its 2021

The cardiac monitor maker had a series of setbacks following Novitas Solutions' Medicare rate cut, including a stock free fall and a new CEO resigning after 4 months. Here's our coverage of iRhythm in 2021. 

Dec. 30, 2021

User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

Dec. 28, 2021

Philips: Compounds in recalled devices 'not typically' associated with long-term health risks

Despite further testing, the company did not change its guidance for physicians or patients, which was given due to the recall of millions of sleep apnea and ventilator machines.

By Ricky Zipp • Updated Dec. 23, 2021

FDA seeks feedback on 180-day notice period for termination of COVID-19 EUAs

The agency's plan is intended to avoid supply disruptions while moving back toward the regulatory requirements of routine operations.

By Nick Paul Taylor • Dec. 23, 2021

Hospitals clamp down on elective surgeries as COVID-19 surges

Cleveland Clinic, Banner Health and other hospital systems are pausing nonessential procedures, while provider groups issued a joint statement Friday declaring that doctors and nurses are exhausted and heartbroken.

By Susan Kelly • Dec. 22, 2021

CDRH warns review timelines will remain extended in 2022 as pandemic pressures continue

The FDA's Center for Devices and Radiological Health expects "a gradual transition back toward normal review timelines" next year as COVID-19 has delayed traditional work.

By Nick Paul Taylor • Dec. 22, 2021

Most COVID-19 medical device EUAs lack documented supporting data: JAMA

The use of "low-quality data" is reasonable at the start of a crisis but FDA should consider raising the standard of evidence after multiple products come to market, according to the authors of the study.

By Nick Paul Taylor • Dec. 21, 2021

FDA warns about Log4j cybersecurity vulnerabilities in medical devices

The bugs in Apache's Java-based open source logging library could potentially allow unauthorized users to remotely impact the safety and effectiveness of device functionality, according to the agency.

By Greg Slabodkin • Dec. 20, 2021

At an 'inflection point,' Smith & Nephew predicts faster growth will follow current challenges

CFO Anne-Françoise Nesmes said there is a procedure backlog from COVID-19 but added that the "new variants of COVID are a reminder of how difficult it is to predict the timing of the recovery."

By Nick Paul Taylor • Dec. 20, 2021

J&J device chief on company split, omicron surge, robotic surgery

Ashley McEvoy is confident that 2022 will not be as bad as the first or second year of the COVID-19 pandemic, even as the omicron variant drives cases up, but adds that "we're not out of the woods yet."

By Ricky Zipp • Dec. 20, 2021

Getinge intra-aortic balloon pump recall tied to 1 death, 71 complaints

The Class I recall, initiated due to a risk that leaking fluid could shut down the heart assist device, is the second in recent months for the pump after reports of defective batteries in a small number of units.

By Susan Kelly • Dec. 17, 2021

3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures

While the emergence of the omicron variant is muddying next year's medtech outlook, analysts have identified three niches within the sector best positioned to successfully weather the continued strains on the healthcare system.

By Susan Kelly • Dec. 15, 2021

Medtronic's stock price falls nearly 9% following FDA warning letter

The medtech giant’s stock continued to drop following the Wednesday announcement, while insulin pump rival Tandem Diabetes Care’s was boosted by roughly 9.5% when the market closed Thursday.

By Ricky Zipp • Updated Dec. 17, 2021

Medtronic's Covidien initiates ventilator recall due to manufacturing error

Puritan Bennet 980 series ventilators can become inoperable during use, according to the FDA recall database. The agency labeled the recall a Class I event, the third such classification for the product since 2015.

By Ricky Zipp • Updated Dec. 14, 2021

Roundup: Baxter completes $10.5B Hillrom acquisition

Wall Street analysts have questioned the price and strategic fit of the deal, which is the largest medtech buy so far in 2021.

Dec. 14, 2021