Tandem CEO on Omnipod 5 competition, pharmacy distribution, Type 2 growth

John Sheridan spoke to MedTech Dive about international growth, creating an insulin pump system for Type 2 patients and what Insulet's Omnipod 5 launch and Medtronic's FDA warning letter mean for Tandem.

By Ricky Zipp • Jan. 20, 2022

FDA misses MDUFA V deadline after months of contentious talks

The agency has failed to send the final MDUFA V user fee agreement to Congress by the Jan. 15 deadline, suggesting there may be unresolved disagreements with industry over elements of the program.

By Nick Paul Taylor • Jan. 19, 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

CDRH pledges greater focus on women's health data

The center's strategic plan creates a framework for addressing FDA's priorities in the area of women's health, including representation in biomedical research.

By Susan Kelly • Jan. 19, 2022

Dexcom CEO on G7's global launch, COVID-19 slowing new patient adds, international growth

Kevin Sayer spoke to MedTech Dive about the upcoming launch of the G7 CGM system, further expanding Dexcom ONE and feeling pandemic pressure in the fourth quarter.

By Ricky Zipp • Jan. 18, 2022

Cybersecurity leads ECRI's list of top medtech hazards for 2022

Cyber incidents can compromise patient care and attacks against hospitals have become more prevalent in recent years. However, ECRI said the worst consequences are preventable.

By Elise Reuter • Jan. 18, 2022

FDA advises physicians to consider alternatives to Endologix AFX2 endovascular grafts

The agency said providers need to be aware that "the majority of available data" link earlier AFX endovascular graft versions to more health risks compared to similar treatments. Cook Medical and Medtronic could benefit.

By Nick Paul Taylor • Jan. 14, 2022

Medtech M&A, IPOs hit new highs as more buyers enter the space: SVB

In a new report, Silicon Valley Bank projects that medical device mergers and acquisitions "will stay hot, as a diverse set of acquirers compete for the top deals," but sees a slowdown in initial public offering activity.

By Nick Paul Taylor • Jan. 14, 2022

Intuitive's da Vinci shipments beat Q4 expectations, COVID-19 impact to last through 2022

The robotic surgery maker said during a J.P. Morgan healthcare conference presentation that it shipped a total of 1,347 da Vinci robots in 2021, a 44% increase from 2020.

By Elise Reuter • Jan. 13, 2022

Neurological devices, diagnostics dominate latest FDA breakthrough designations

The agency has granted breakthrough designations to several devices for neurological conditions, including an autism test and treatment as well as diagnosis of Parkinson's disease.

By Nick Paul Taylor • Jan. 13, 2022

Philips ups recall provisions by $250M, impacted devices to more than 5M

The Dutch medtech said the recall and supply chain issues are the primary reasons for missing fourth-quarter sales expectations by about $400 million. Philips' shares were down more than 15% early Wednesday.

By Ricky Zipp • Jan. 12, 2022

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

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