Ambu has a reimbursement win for its single-use bronchoscope

The aScope 5 Broncho HD single-use bronchoscope [Image courtesy of Ambu]Ambu announced today that CMS has approved a transitional pass-through (TPT) payment for its aScope 5 Broncho HD.

The TPT payment, effective Jan. 1, 2024, will last for 24–36 months, allowing incremental reimbursement for outpatient procedures using the device​​.

The aScope 5 Broncho HD series is Ambu’s latest generation of single-use bronchoscope. Cleared by the FDA in 2022, it has advanced imaging and design features, including a new high-resolution camera chip. It’s part of a single-use portfolio that Ambu has grown over the past 14 years to include 10 different bronchoscopy models designed to meet patient needs in interventional pulmonology, critical care medicine, and anesthesia and airway management. T

Ambu said the TPT was granted to the aScope 5 Broncho HD series because it fit CMS criteria, which included demonstrating a substantial clinical improvement over existing sing…

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Ambu names new chief financial officer

Ambu today announced it appointed Henrik Skak Bender as chief financial officer, effective January 1, 2024.

Bender will replace Thomas Frederik Schmidt, who intends to step down on December 31. Under Schmidt’s leadership, the company said in a news release it returned to positive free cash flow and it has taken the first steps toward strong profitable growth. Ambu plans to focus on accelerating growth and improving profitability with Bender’s appointment.

“In the progression of Ambu’s Zoom In strategy, I have, together with the Board, decided to bring in a new leadership profile to execute on the next phase of Ambu’s transformation and growth journey. I am convinced that Henrik is the right profile for the CFO role at Ambu, as he brings strategic and operational experience from global companies, as well as the medical device industry. On behalf of myself and the Board, I want to thank Thomas for his contributions to Ambu, and I wish him the be…

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How Ambu seeks to hold its top spot in single-use scopes

Ambu CEO Britt Meelby Jensen [Image courtesy of Ambu]

Ambu’s CEO seeks to “Zoom In” on what the Danish company has done best.

More than a year after she took over the corner office at Ambu, Britt Meelby Jensen recalls what brought her into leadership. She already had a seat on the board at the maker of single-use endoscopes, anesthesia and airway management devices, and patient monitoring technology.

“We were in a situation where we saw challenges with declining profitability and we were not able to meet our revenue targets that we had put out to The Street. So it was around that time the chairman asked if I wanted to run the company,” Jensen said during a recent DeviceTalks Weekly podcast interview.

In many ways, Ambu’s challenges stemmed from its success. The Danish company, founded in 1937, launched the Ambu Bag in the 1950s. The self-inflating, manual resuscitator is still a fixture in hospital e…

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Ambu wins CE mark for therapeutic gastroscope

The aScope gastro. [Image from Ambu]Ambu announced that it launched its new, larger-sized gastroscopy solution in Europe after receiving CE mark approval.

The aScope gastro large and Ambu aBox 2 expand the company’s gastroenterology (GI) offerings in Europe. It designed and tested the solution in close collaboration with leading GI experts. Ambu targets an expansion of more than 1.5 million annual procedures with the system.

According to a news release, the aScope gastro large and aBox 2 mark the world’s first gastroscope with a 4.2 mm working channel. That enables a powerful suction performance form the therapeutic gastroscope while providing maneuverability and precision. The company says this facilitates access to difficult-to-reach anatomical areas.

aScope gastro large delivers significantly higher suction performance compared to the latest 3.7 mm gastroscope on the market, Ambu said. It achieves this both with and without tools. The system …

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Layoffs in medtech: These companies recently reduced their workforce

[Image courtesy of Nastuh Abootalebi on Unsplash] The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs.

You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more.

For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply chain challenges and more.

Medtech has shown some resilience in the present environment. Some major medical device companies released positive earnings.  However, others announced headcount reductions, citing macroeconomic headwinds. Others felt the weight of regulatory issues and restructuring efforts.

Here are a few companies across medtech that enacted layoffs over the past several months.


In 3M’s fourth-quarter earnings report, the company announced that it plans to reduce its global manufacturing workforc…

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DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

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New Ambu plant in Mexico is its largest

[Image from Ambu]Ambu announced today that it hosted a grand opening for its new manufacturing plant in Ciudad Juárez, Mexico.

Ballerup, Denmark–based Ambu hosted the grand opening of its largest plant on Oct. 11. With a total capacity nearing 323,000 square feet, Ambu’s facility helps to ramp up future production and supply of products. Ambu develops single-use scopes.

The company said in a news release that it sought to secure growing manufacturing capacity amid supply chain instability. Its new factory represents a strategic step to move closer to the North American market. Ambu said it provides a more sustainable and flexible approach to supply chain constraints. This allows for cost-effective transportation and an improved supply of products to customers.

“The opening of our new manufacturing site in Mexico is a major milestone for Ambu. Delivering high-quality, innovative products to our customers is our number one priority, and it has been a ke…

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Diversity in medtech: 2022 markedly the best for women in medtech

This year has been one of the most formative for women in medtech leadership roles as representation in the C-suite has reached a new high.

Just 23% of the top executives at the world’s 100 largest medical device companies are women, according to an analysis of Medical Design & Outsourcing‘s annual Big 100 ranking of the top revenue-generating medtech companies.

While that number is up 2 percentage points from 2021, the average composition within the top 100 companies is also up slightly to 22%.

This year has been one of the most formative for women in leadership roles. There were 50 new C-suite appointments. However, 2020 seemingly started the shift in leadership diversity. That year, 37 women moved into C-suite roles in the top 100 companies, followed by 34 new appointments in 2021. Overall, women have moved into 121 new roles in the last three years.

“The fact that the management teams are now tapping into this in 2020 and…

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Ambu says 70% of layoffs are completed

Ambu announced today that it has completed nearly three-quarters of its workforce reduction as part of its cost reduction program.

The Ballerup, Denmark–based developer of single-use scopes announced earlier this month that it was set to let go of 200 employees as it looked to cut costs. The reduction program aims to strengthen Ambu’s free cash flow and improve profitability to support future growth.

Ambu anticipates savings around roughly DKK kr250 million ($40 million) per year from the cuts, with DKK kr150 million ($24 million) expected in one-time expenses.

In an interim report for the company’s third quarter, Ambu said that, as of today, 70% of the reductions concerning its global workforce have been completed.

Ambu has reported a total of 4,500 employees in the past, meaning that the layoffs would represent approximately 4% of its workforce.

Britt Meelby Jensen, CEO of Ambu, said in a news release that the company continue…

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Ambu is letting go of 200 employees

Ambu recently announced that it would cut 200 employees from its global workforce as part of a cost reduction program.

The Ballerup, Denmark–based company has reported trouble making headway with its single-use scope products.

Ambu has reported a total of 4,500 employees in the past. That means the layoffs would represent about 4% of Ambu’s workforce.

Ambu expects to save roughly DKK kr250 million ($40 million) a year from the cuts, with DKK kr150 million ($24 million) in one-time expenses.

“We have had great successes, but also challenges,” Ambu CEO Britt Meelby Jensen said in an Aug. 3 news release.

She went on: “I have assessed the situation with the leadership team, and it is clear that the single-use market remains very attractive, but also that it is taking longer than expected to penetrate certain segments like duodenoscopy. To strengthen our financial position and flexibility, we have decided to launch a cost…

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Ambu wins FDA clearance for 5th-gen single-use bronchoscope

[Image from Ambu]Ambu announced today that it received FDA 510(k) clearance for its aScope 5 Broncho family of sterile, single-use bronchoscopes.

Ballerup, Denmark–based Ambu designed the aScope Broncho with advanced imaging and design features, including a new high-resolution camera chip.

The company received European regulatory clearance in May of this year and said in a news release that it will proceed with the commercialization of aScope 5 Broncho, as well as the full high-definition Ambu aBox 2 processing unit in both Europe and the U.S. following the latest regulatory nod.

Ambu said that, with the advanced imaging and design features including the high-resolution camera chip, aScope 5 Broncho delivers superior image quality in combination with the aBox 2.

The fifth-generation bronchoscope offers sterility along with high performance, plus advanced technology, portability and cost-effectiveness, the company said. Its versatility ranges across c…

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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…

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