Butterfly Network Archives - Medical Design Sourcing

Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year

The IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system.

The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe.

According to a news release, the additional certification allows Butterfly Network to release important new features to all existing and prospective European customers. That includes its pulse wave doppler (PWD) in presets and its AI-enabled auto B-line counter. Butterfly expects to roll out these additional functionalities within the second quarter of 2024.

The new feature release spans Europe, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK. Butterfly iQ+ can…

Butterfly Network rolls out next-gen ultrasound-on-chip tech in the U.S.

The iQ3 handheld ultrasound system. [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it launched its iQ3 third-generation handheld point-of-care ultrasound system.

The Butterfly iQ3 point-of-care ultrasound (POCUS) system is a semiconductor-based, single-probe, whole-body ultrasound offering. iQ3 features a brand-new ergonomic design and provides double the data processing speed compared to previous generations. The FDA cleared the iQ3 system last month.

Burlington, Massachusetts–based Butterfly powers the iQ3 with its most advanced semiconductor chip. It features a data transfer rate that doubles that of its predecessor. This results in enhanced image quality and faster micro-beamforming for advanced 3D capabilities called iQ Slice and iQFan.

Other enhancements include a 17% smaller probe face and a 7% shorter probe with ergonomic weight distribution. iQ3 features three configurable control buttons, has a 2.5-times fa…

FDA clears next-gen handheld ultrasound from Butterfly Network

A teaser image of the iQ3 handheld ultrasound system. [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system.

BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%.

The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- based Butterfly develops semiconductor-based, single-probe, whole-body ultrasound technology. iQ3 features a brand-new ergonomic design and provides double the data processing speed compared to previous generations.

According to a news release, the new system optimizes image resolution, sensitivity and penetration. It also enables faster 3D capabilities to power novel, automated image capture modes called iQ Slice and iQ Fan.

Butterfly’s technology goes beyond just p…

Butterfly Network to bring Ultrasound-on-Chip tech to surgical robotics

The original Ultrasound-on-Chip technology. [Image from Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it partnered with Mendaera to commercialize a new surgical robotic system.

Mendaera, a Silicon Valley-based company develops medical robotic technology. Its platform combines robotics, real-time imaging, AI and connectivity to enable intervention at scale. The company recently completed the research and design process for its novel robotic system and added $24 million in Series A funding in August.

Butterfly Network and Mendaera agreed to commercialize a novel robotic system powered by Butterfly’s Ultrasound-on-Chip technology. The Burlington, Massachusetts-based company develops the technology for handheld ultrasound and recently announced a foray into brain-computer interfaces.

Mendaera’s technology is compatible with Butterfly’s ultrasound device, according to a news release, and connected by the company’s B…

5 more brain-computer interface companies you need to know

BCI technology from Cognixion, Precision Neuroscience, InBrain Neuroelectronics and Kandu Health.

The brain-computer interface (BCI) space continues to rise in notoriety, and a number of players are throwing their hats in the ring.

Such technologies could enable users to control a computer with their brain, or even go beyond that. Countless immobile people someday could control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking.

Big names have already established their presence in the space. Elon Musk’s Neuralink continues to make headway, while Bill Gates- and Jeff Bezos-backed Synchron has an innovative catheter-delivered implant. Blackrock Neurotech, which has a next-generation BCI, has been implanting its Utah Array in patients since 2004.

Those companies and more were covered in last year’s roundup of brain-computer interface companies you need to know. But there are several more companies ou…

Butterfly Network, Razom expand partnership to bring more handheld ultrasound to Ukraine

The Butterfly Network IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it partnered with Razom to bring additional handheld ultrasound devices to Ukraine.

Razom, a U.S.-based nonprofit, offers support to Ukraine. The company considers itself a leader in driving point-of-care ultrasound (POCUS) training and utilization there.

To date, it already deployed more than 400 Butterfly iQ+ handheld ultrasound devices in the country. The expansion of this partnership with Butterfly Network brings an additional 200 of those devices to the frontlines.

Butterfly IQ+, a transducer system, uses semiconductor technology to perform whole-body imaging using a single handheld probe. The company’s proprietary Ultrasound-on-Chip technology powers the system. It connects to a mobile device and uses AI to deliver advanced imaging.

“At Butterfly, improving access to ultrasound technology in austere, under-resourced or …

Butterfly Network posts Q2 results, announces new AI marketplace

The Butterfly Network IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) shares rose today on second-quarter results that topped the consensus forecast.

Shares of BFLY ticked up 3.8% at $2.44 apiece in midday trading today. MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, dipped 0.7%.

The Burlington, Massachusetts–based handheld ultrasound developer posted losses of $28.7 million, equalling 14¢ per share. Butterfly posted sales of $18.5 million for the three months ended June 30, 2023. It recorded a $7 million bottom-line gain on a sales decline of 3.8%.

Losses per share came in 2¢ ahead of expectations on Wall Street, while sales topped projections of $18 million.

“During the quarter, we conducted a full strategy reevaluation; chose a focused, impactful plan, completed a reorganization to give us time to fund the plan, and implemented growth initiative…

Butterfly Network shares slide on Q1 results

Butterfly Network (NYSE:BFLY) shares dropped today on first-quarter results that fell short of sales expectations.

Shares of BFLY dropped 16% to $1.88 apiece in morning trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was relatively flat at the same time.

The Burlington, Massachusetts-based handheld ultrasound technology maker posted a loss of $33.5 million. That comes to -17¢ per share on sales of $15.5 million for the three months ended March 31, 2023.

Losses per share were 4¢ better than expectations on Wall Street. Sales were flat from the prior-year period and fell short of projections, as analysts were expecting $15.8 million in revenues.

Product revenue decreased 20% to $8.8 million, while software and other services revenue increased 45% to $6.6 million.

Operating expenses were down 24% to $44.1 million for the quarter following layoffs in August 2022 and January 2…

Butterfly Network projects around 20% sales growth in 2023

The Butterfly Network IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) shares ticked up today on fourth-quarter results that topped the consensus earnings per share forecast.

Shares of BFLY rose 12.6% to $2.50 apiece in early-morning trading today.

The Burlington, Massachusetts-based handheld ultrasound technology maker posted losses of $33.7 million. That comes to 17¢ per share on sales of nearly $19 million for the three months ended Dec. 31, 2022.

Losses per share landed 5¢ ahead of expectations on Wall Street. However, sales fell short of projections, as analysts looked for $19.9 million in revenues.

Butterfly Network more than doubled its losses from this time last year. Its sales came in nearly identical to the fourth quarter of 2021. The company said it “tightly managed” expenses during the quarter, recording a monthly cash use of approximately $10 million. That marks a significant decrease from $18 mil…

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…

The biggest medtech personnel moves in 2022

Some of the largest companies in medtech have promoted, replaced or removed leaders in recent months.

In July, Medical Design & Outsourcing compiled a list of the biggest personnel changes in the first half of 2022. Those included hirings, firings, promotions and retirements of CEOs, presidents and and other business leaders across the medtech industry.

The latter half of the year has brought even more changes. To close out 2022 and prepare for 2023, here are more of the year’s biggest medtech moves — and some updates since the news first broke.

Butterfly Network CEO steps down

Todd Fruchterman

On Dec. 6, Butterfly Network (NYSE:BFLY) announced that it reached a mutual agreement with Dr. Todd Fuchterman to step down as president and CEO. Fruchterman also left Butterfly’s board of directors.

Fruchterman oversaw Butterfly’s development of artificial intelligence-based ha…

Butterfly Network CEO steps down

Todd Fruchterman. [Image from the Butterfly Network website]Butterfly Network (NYSE:BFLY) announced that it came to a mutual agreement for Dr. Todd Fuchterman to step down as president and CEO.

Fruchterman also leaves his position as a member of Butterfly’s board of directors. He intends to partner with the company’s leadership team through the year to ensure a smooth transition.

“On behalf of the board, I want to thank Todd for his vision, passion and dedication to Butterfly during his tenure,” said Jonathan Rothberg, Butterfly founder and chair of the board. “Todd has built a highly capable leadership team, who will function in the interim to ensure continuity while we conduct a search for a new chief executive who will continue the company’s growth.”

Butterfly tabbed Rothberg to serve as interim CEO during the transition period. His responsibilities include working with the executive team to drive the company forward and ensure business conti…