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

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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

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

Neurostimulator to treat stroke fails to gain FDA advisory panel support

The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.

By Susan Kelly • Dec. 13, 2021

FDA seeks comment on 3D printing of medical devices at hospitals, doctor's offices

The agency's discussion paper lays out the benefits and challenges of creating 3D-printed devices in healthcare settings as well as a potential approach for regulatory oversight.

By Greg Slabodkin • Dec. 13, 2021

Canada regulations news for medical devices and IVDs

The new Canadian requirement for summary reports goes into effect on 18 Dec. 2021. Learn how to leverage your PSUR for an efficient submission.

By Nancy Morrison, RQM+ • Dec. 13, 2021

Edwards sees double-digit 2022 sales growth boosted by another TAVR jump

The cardiac device maker estimated 12% to 15% growth next year for transcatheter aortic valve procedures. During its annual investor conference, Edwards also updated future growth projections for key markets.

By Ricky Zipp • Dec. 9, 2021

FDA floats independent contractor to track MDUFA hiring following medtech pressure

The agency made the offer during the Medical Device User Fee Amendments V meetings in response to industry negotiators who want a clearer picture of how the program uses the money it receives.

By Nick Paul Taylor • Dec. 9, 2021

Study finds surgery volumes bounced back after 2020 COVID-19 shutdown, confirming medtech sales trends

Confounding factors such as healthcare staffing shortages caused the delta variant headwind to drag on — and, now, rapidly increasing inpatient volumes are leading U.S. hospitals to once again delay surgical procedures.

By Nick Paul Taylor • Dec. 9, 2021

Study links cochlear implants to new bone formation, long-term residual hearing loss

Ultra-high spatial resolution CT detected new bone formation in two-thirds of the patients within four years of implantation, which adversely affected their long-term hearing preservation, according to a study in the journal Radiology.

By Nick Paul Taylor • Dec. 8, 2021

Implantable cardioverter defibrillators are underused in women, racial minorities: study

The proportion of people who received an ICD rose from 11.6% in 2003 to 17% in 2014, according to the Mayo Clinic study. However, that overall figure masks differences between patient groups.

By Nick Paul Taylor • Dec. 8, 2021

Tandem Diabetes Care targets 1M customers by 2027

The insulin pump maker expects to triple its installed units over the next five years behind new product launches and capturing market share as use among Type 1 and Type 2 patients is projected to take off.

By Ricky Zipp • Dec. 7, 2021

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

By Nick Paul Taylor • Dec. 7, 2021

Insulet's Omnipod 5 insulin pump cleared by FDA after months of delays, sending shares up 9%

The clearance better positions Insulet to compete with rival Tandem Diabetes Care, and comes while Medtronic's diabetes group is managing multiple product safety problems.

By Susan Kelly , Ricky Zipp • Updated Jan. 28, 2022