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Better Therapeutics expects FDA ruling on diabetes digital therapeutic mid-year

Better Therapeutics (Nasdaq:BTTX) shares fell today after its first-quarter earnings report included a wide-ranging business update.

Shares of BTTX fell 3.2% at 76¢ apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.2%.

Better Therapeutics recorded a net loss of $9.4 million, compared to $9.7 million for the same period in 2022. On a per common share basis, net loss totaled 39¢, while analysts expected harsher losses of 74¢ per share.

The San Francisco-based digital therapeutic developer reported that it responded to a February request for information from the FDA. It relates to the company’s de novo submission for BT-001, a digital therapeutic for treating type 2 diabetes. The company submitted an FDA de novo request in September 2022 for the solution. FDA review remains ongoing and Better Therapeutics said it expects a decision to come in…

Philips to pay more than $62M to settle FCPA charges

The U.S. SEC announced that Philips (NYSE: PHG) + will pay $62 million to resolve charges that Chinese subsidiaries violated the Foreign Corrupt Practices Act.

The Dutch medtech giant consented to yesterday’s SEC order without admitting or denying the agency’s findings. It’ll pay $15 million in civil penalties and more than $47 million in disgorgement and prejudgment interest.

The SEC’s order claimed that Philips’ China operations engaged in a number of practices that violated FCPA practices.

Philips China used special price discounts with distributors that created a risk that excessive distributor margins could be used to fund improper payments to government employees.

Employees, distributors, or sub-dealers of Philips’ China subsidiaries improperly influenced hospital officials to draft technical specifications in public tenders to favor Philips’ products. For example, the order found that, …

Embecta stock rises on Q2 results, reports progress on automated insulin delivery tech

Embecta (Nasdaq:EMBC) shares ticked up today on second-quarter results that topped the consensus forecast, leading to a guidance increase.

Shares of EMBC grew 2.1% to $29.52 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.1%.

The Parsippany, New Jersey-based diabetes technology company posted profits of $14 million. That amounts to per share on sales of $277.1 million for the three months ended March 31, 2023.

Embecta, which spun off from BD last year, recorded a bottom-line slide of 82.4% on sales growth of 0.9%.

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

Johnson & Johnson MedTech: ‘Stay tuned’ for Ottava next-gen surgical robot

Martin Buehler.

It’s been about two and a half years since Johnson & Johnson (NYSE:JNJ) unveiled its plans for a next-generation surgical robot.

At the time, the six-armed “Ottava” system generated a lot of buzz. Johnson & Johnson shared details on the surgical robotic platform set to offer unrivaled flexibility and control compared to the rest of the market. It features six arms to provide more control and flexibility in surgery, while those arms will be integrated into the operating table.

The company said its platform has a zero-footprint design to enable patient access, increase space in the operating room and improve workflow.

Over the past 30 months, though, the company remained tight-lipped over developments with the platform. In October 2021, J&J pushed back the platform’s development timeline by about two years due to multiple factors. It initially expected was to begin the verification and validation processes for …

Philips shareholders vote against relieving management of liability

Royal Philips shareholders voiced their displeasure with management’s handling of the company’s massive respiratory device recall at the annual meeting this week.

Shareholders voted down a proposal to relieve the board of management of liability, keeping the potential for investor lawsuits related to the Philips Respironics recall on the table.

“This follows the voting guidance from certain proxy advisors to signal discontent in respect of one former member of the Board of Management,” the company said in a news release, without naming that member.

“We appreciate the support expressed by the shareholders regarding current management and direction of Philips,” Royal Philips Supervisory Board Chair Feike Sijbesma said in the release. “Under the leadership of its new CEO Roy Jakobs, Philips is fully focused on implementing the plan to create value with sustainable impact for our shareholders and all other stakeholde…

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…

FDA approves expanded label for Abbott Eterna spinal cord stimulation tech

The Eterna spinal cord stimulation (SCS) system [Image courtesy of Abbott]Abbott (NYSE:ABT) announced today that the FDA approved expanded MRI labeling for its Eterna spinal cord stimulation (SCS) system.

The expanded labeling includes new leads that are MR conditional. It means people with chronic pain can undergo MRI scans within approved, outlined conditions with a wider selection of lead options for full-body scans. Eterna SCS with TotalScan MRI now provides fully-body MRI capabilities. It also features normal operating mode scanning with select leads.

FDA approved Eterna in December 2022.

Abbott cited recent findings from its own study demonstrating that 93% of surgeons consider MRI accessibility an important to essential factor when determining the best SCS system for their patients. This study also revealed that surgeons place a high value on the ability to implant leads in the epidural space. Those surgeons want to accomplish this while still remain…

FDA clears Samsung Galaxy smart watch for AFib detection

[Image courtesy of Samsung]Samsung Electronics announced that the irregular heart rhythm notification feature of its health monitor app received FDA clearance.

Combined with the app’s existing on-demand ECG function, the feature proactively monitors heart rhythms suggestive of AFib. It all works straight from the user’s wrist through the Samsung Galaxy Watch.

“We’re excited to announce that irregular heart rhythm notification, designed to help millions of people around the world who may not be aware of a potential heart risk, has been cleared by the FDA,” said Hon Pak, VP and head of the digital health team, MX business at Samsung Electronics. “This is yet another example of how Samsung prioritizes proactive safety solutions and enables users to receive a more holistic understanding of their cardiovascular and overall health.”

Galaxy Watch utilizes the Samsung BioActive sensor. It includes on-demand ECG recording and heart rhythm alert functions…

BD CEO Tom Polen discusses crises-revealing character during COVID-19 pandemic

BD CEO, President and Chair Tom Polen [Photo courtesy of BD]Tom Polen’s original “master plan” included going to medical school. While preparing for the MCAT out of undergrad, he instead joined a small startup based in California.

Ultimately, the startup grew and BD (NYSE:BDX) bought it. That was about 23 years ago. Polen is now chair, president and CEO of the medtech giant, having assumed the role in early 2020.

He noted that BD acquired nine companies in the last three years — much like his startup many years before.

“It’s a pleasure to be able to stand in front of those teams when we bring them in as part of our family and say, ‘I came to BD the same way that all of you came to BD,'” Polen says. “I remember exactly the way that that first day felt.”

Speaking in a keynote address at DeviceTalks Boston today, Polen outlined his career path and how he’s led BD for the past three years.

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Steris beats the Street on Q4 earnings and increases guidance

Steris (NYSE:STE) today reported fourth-quarter results that exceeded Wall Street’s expectations while upping guidance for the year ahead.

Shares of STE climbed 4% t0 $197 apiece in after-hours trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was flat on the day.

The Dublin, Ireland-based provider of sterilization services and other infection prevention tech posted profits of $187.2 million in the quarter ended March 31, 2023. That amounts to $1.89 per share on sales of $1.38 billion.

Steris recorded a 259% bottom-line gain on sales growth of 14.3%.

Adjusted to exclude one-time items, earnings per share (EPS) totaled $2.30. Wall Street analysts were expecting adjusted EPS of $2.15 on sales of $1.27 billion.

“We are pleased to end the year with strong performance,” Steris President and CEO Dan Carestio said in a news release. “Our teams worked diligently to meet customer de…

DeviceTalks Boston: The ZimVie Tether helps kids with scoliosis — if they can get it in time

The ZimVie Tether system is FDA approved for adolescent idiopathic scoliosis under a humanitarian device exemption. [Image courtesy of ZimVie]The ZimVie (Nasdaq:ZIMV) Tether is a groundbreaking system for treating adolescent idiopathic scoliosis, developed with the help of surgeons who saw an opportunity to improve the lives of their pediatric patients.

But for every patient the clock is ticking, as children are only eligible if they have enough growth ahead of them for the technology to make a difference. And all too often, insurance companies can delay the treatment so long that patients are no longer eligible if and when insurers approve the procedure.

ZimVie SVP and Global Spine President Rebecca Whitney spoke about the systems development and commercialization with ZimVie Spine Global R&D Director Ryan Watson today at DeviceTalks Boston.

“We’ve worked for years to make sure that we have the right options available for these kids because it is a spe…

CardiaCare names Ken Nelson as chair of its board

CardiaCare announced that it appointed digital health, medical device and remote patient monitoring veteran Ken Nelson as its board chair.

Nelson brings 20 years of medtech experience, including a track record of building successful sales, marketing and commercialization teams.

“Ken brings a wealth of market development, commercialization and sales experience in the cardiac monitoring and cardiac rhythm management space,” said Ofer Halbreich, CEO of CardiaCare.

Halbreigh added that Nelson joins as CardiaCare ramps up multiple clinical trials for its wearable device for AFib treatment.

The clinical-stage digital therapeutic company develops a closed-loop wearable device. It offers a noninvasive treatment for cardiac and other central nervous system-related clinical symptoms. The nerve stimulation system has continuous monitoring and AI-based alert capabilities. It enables complete remote patient management and personalized treatment. Read more