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FDA clears Insulet Omnipod 5 for children two years and older

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes.

Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older.

In June, the company presented data supporting the use of Omnipod 5 in young children, with the platform significantly improving time in range and reducing HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use.

Get the full story at our sister site, Drug Delivery Business News.

Insulet posts Q2 sales beat, raises full-year guidance

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq:PODD) shares were unmoved after hours today on second-quarter results that topped the consensus revenue forecast.

The Acton, Massachusetts-based automated insulin delivery technology developer posted losses of, or 50¢ per share, on sales of $299.4 million for the three months ended June 30, 2022, for a $10 million bottom-line slide deeper into the red on sales growth of 13.8%.

Get the full story at our sister site, Drug Delivery Business News.

Insulet begins full market launch for Omnipod 5

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq:PODD) announced today that it commenced the full market launch for its next-generation Omnipod 5 system.

The Omnipod 5 automated insulin delivery (AID) system has now been made fully available through U.S. retail pharmacy channels for individuals aged six years and older with type 1 diabetes.

Get the full story at our sister site, Drug Delivery Business News.

6 drug delivery innovations you need to know

From wearable insulin delivery devices to drug-eluting implants and everything in between, drug delivery innovation never stops.

Vaccines, life-saving therapeutics, vision-correcting drugs and more are being developed and marketed for delivery with all kinds of technologies.

More than a year ago, we compiled a list of eight drug delivery innovations you need to know. With some updates on some of those technologies, plus introductions to others, here are some more impressive developments you should keep an eye on:

1. Needle-free delivery

Vaccines have become a major talking point over the past couple of years amid the COVID-19 pandemic and a number of companies are working on ways to deliver them, as well as other forms of medication, through different avenues.

A major speed bump in vaccine hesitancy can be fear of needles, so the introduction of needle-free drug delivery could make big waves in the space.

Two companies pushing forward with …

The biggest medtech personnel moves so far in 2022

In the ever-changing world of medtech, those who are leading the companies are bound to move around a bit.

At the end of last year, we compiled a list of medtech’s biggest personnel changes in 2021. Throughout just over half of 2022, we’ve already seen a slew of major moves around some of the space’s most powerful players.

Here is a list of some of the biggest personnel changes in medtech so far in 2022:

3M’s healthcare president retires 3M Health Care Business Group President Mojdeh Poul [Image courtesy of 3M]Mojdeh Poul, the president of 3M’s healthcare business, announced in May that she would retire from the position and her retirement was made effective on July 1.

Poul joined 3M in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions, including infection prevention, 3M Canada, and sa…

July 2022 Issue: Pulsed-field ablation, DeviceTalks Boston and the Pharma 50

What is pulsed-field ablation? Here’s what you need to know

Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

Tips for vetting contract manufacturers

They said it at DeviceTalks Boston

FDA can’t explain drop in device recalls, but experts point to COVID disruption

2022 Pharma 50: The 50 largest pharmaceutical companies

Innovators shake up the Pharma 50

As a father raising a toddler and an infant, I was relieved by the latest milestone in the COVID-19 pandemic: the authorization of vaccines for children between 6 months and 5 years.

The good news came as Pharma Editor Brian Buntz and the rest of our team were putting the final touches on this edition’s Pharma 50 project. It’s our annual ranking of the biggest pharmaceutical companies by global revenue, featured on our affiliated Drug Discovery & Development site. (Our Big 100 report on largest medic…

They said it at DeviceTalks Boston

Proximie CEO Nadine Hachach-Haram [Photo courtesy of Proximie]Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead.

Here are some of the most quotable insights from panelists and speakers at our live event.

And make sure to save the date — and save your seat — for DeviceTalks West in Santa Clara, California on Oct. 19 and 20.

Get the full story at our sister site, Medical Design & Outsourcing.

They said it at DeviceTalks Boston

Proximie CEO Nadine Hachach-Haram [Photo courtesy of Proximie]

Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead.

Here are some of the most quotable insights from panelists and speakers at our live event.

And make sure to save the date — and save your seat — for DeviceTalks West in Santa Clara, California on Oct. 19 and 20.

Read on to hear what medtech leaders had to say at DeviceTalks Boston 2022.

Next >>

The biggest stories from the American Diabetes Association (ADA) 2022 Scientific Sessions

For the 82nd time, the American Diabetes Association (ADA) Scientific Sessions convened to highlight all the innovations within the diabetes technology space.

Major players like Dexcom, Medtronic, Abbott and more continue to plug along, while companies like Bigfoot Biomedical, One Drop and others shared data backing the technology that they bring to the table.

The data showcased at ADA supported the usual continuous glucose monitoring (CGM) and automated insulin delivery (AID) technology, plus different digital health platforms and diabetes reversal procedures.

BTIG analyst Marie Thibault wrote in a report that there was plenty of buzz on the ground at the event, particularly around Insulet’s Omnipod 5 AID system, Abbott’s recently FDA-cleared FreeStyle Libre 3 CGM and Bigfoot Biomedical’s Bigfoot Unity platform.

“In general, we believe that accuracy and clinical benefit is proven for all commercial CGM and AID offerings an…

Insulet’s Omnipod 5 “significantly improves” glycemic outcomes in very young children

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq:PODD) announced data supporting the use of its Omnipod 5 automated insulin delivery system in young children.

Acton, Massachusetts-based Insulet’s Omnipod 5, which became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. earlier this year, significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use.

Get the full story at our sister site, Drug Delivery Business News.

Insulet breaks ground on $200M manufacturing facility in Malaysia

[Image from Insulet]Insulet (Nasdaq:PODD) announced the groundbreaking of its new Omnipod manufacturing facility in Malaysia.

Acton, Massachusetts-based Insulet’s Johor Bahru, Malaysia-based manufacturing facility will produce its Omnipod automated insulin delivery system and strengthen the company’s global manufacturing capabilities.

Get the full story at our sister site, Drug Delivery Business News.

Insulet breaks ground on $200M manufacturing facility in Malaysia

[Image from Insulet]Insulet (Nasdaq:PODD) announced the groundbreaking of its new Omnipod manufacturing facility in Malaysia.

Acton, Massachusetts-based Insulet’s Johor Bahru, Malaysia-based manufacturing facility will produce its Omnipod automated insulin delivery system and strengthen the company’s global manufacturing capabilities.

Get the full story at our sister site, Drug Delivery Business News.