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Carbon introduces next-gen 3D printers

The M3 printer [Image courtesy of Carbon]

Carbon today announced its next-gen M-Series 3D printers based on DLS technology.

The new M3 and the M3 Max printers boast faster printing, a more straightforward print experience, expanded design space and a more consistent surface finish, according to Carbon.

Carbon said a 4K light engine enables a doubling of the build area with the same pixel size and density, and there is a wide range of high-performance materials.

“With these next-generation printers — combined with our Design Engine software and Carbon DLS materials — design teams across business verticals can create high-quality prototypes with end-use performance quicker and more efficiently than ever before,” Phil DeSimone, Carbon’s chief product and business development officer, said in a news release. “And once the product development is complete, Carbon’s platform enables companies to mo…

What’s really happening with clinical trial innovation?

Image courtesy of Pixabay

The clinical trial landscape has evolved significantly in the past two years. But given the quick embrace of decentralized clinical trials and growing traction of apps, digital health and other technologies in the space, it can be difficult to separate hype from reality.

To learn more about the evolving landscape, we caught up with Libbi Rickenbacher, director of strategy at 4G Clinical, to discuss the ongoing impact of the pandemic, decentralized clinical trials and other relevant trends.

Radical shifts in clinical trials?

The pandemic has undoubtedly disrupted clinical trials, leading to delays and outright cancellation of scores of studies. It may seem like a radical shift, but there was also self-preservation at work, Rickenbacher said.

“For some of those studies, maybe it was better for them to cancel,” she said. “It was very unfortunate for the patients, but you …

Edwards Lifesciences misses on Q4 earnings as omicron hammers hospitals

Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings at the end of trading today that fell short of the consensus forecast on Wall Street, but reaffirmed its outlook for 2022.

The Irvine, California-based heart device company reported profits of $335.3 million — or $0.53 per diluted share — on sales of $1.33 billion for the three months ended Dec. 31, 2021, for a bottom-line gain of 8% and sales growth of 12% compared with Q4 2020.

Transcatheter aortic valve replacement (TAVR) sales grew to $872 million for the quarter, up 12% despite the “pronounced impact on hospital resources in December” from the omicron variant of COVID-19, said CEO Mike Mussallem, who cited the delta variant wave in the company’s third-quarter results.

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

Edwards Lifesciences misses on Q4 earnings as omicron hammers hospitals

Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings at the end of trading today that fell short of the consensus forecast on Wall Street, but reaffirmed its outlook for 2022.

The Irvine, California-based heart device company reported profits of $335.3 million — or $0.53 per diluted share — on sales of $1.33 billion for the three months ended Dec. 31, 2021, for a bottom-line gain of 8% and sales growth of 12% compared with Q4 2020.

Transcatheter aortic valve replacement (TAVR) sales grew to $872 million for the quarter, up 12 percent despite the “pronounced impact on hospital resources in December” from the omicron variant of COVID-19, said CEO Mike Mussallem, who cited the delta variant wave in the company’s third-quarter results.

TAVR sales outside the U.S. grew about 20 percent on an underlying basis in Q4, and Edwards Lifesciences said it continues to project that the global TAVR opportunity will double to $10 billion by 20…

Philips launches at-home, 12-lead ECG for clinical trials

Philips’ new 12-lead, at-home ECG. [Image courtesy of Philips]Royal Philips (NYSE: PHG, AEX: PHIA) announced today that it is expanding its remote cardiac monitoring portfolio with a patch-based, clinical-grade ECG.

The new at-home electrocardiogram monitors could reduce the need for site visits during clinical trials, according to the Dutch medtech giant. At-home ECG is a hot space: iRhythm Technologies CEO Quentin Blackford recently spoke with Medical Design & Outsourcing about iRhythm’s plans to roll out asymptomatic atrial fibrillation (AFib) screening pilots with payors in 2022.

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

Philips launches at-home, 12-lead ECG for clinical trials

Philips’ new 12-lead, at-home ECG. [Image courtesy of Philips]

Royal Philips (NYSE: PHG, AEX: PHIA) announced today that it is expanding its remote cardiac monitoring portfolio with a patch-based, clinical-grade ECG.

The new at-home electrocardiogram monitors could reduce the need for site visits during clinical trials, according to the Dutch medtech giant. At-home ECG is a hot space: iRhythm Technologies CEO Quentin Blackford recently spoke with Medical Design & Outsourcing about iRhythm’s plans to roll out asymptomatic atrial fibrillation (AFib) screening pilots with payors in 2022.

Philips described its device as the industry’s first full-service, at-home, 12-lead electrocardiogram (ECG) for use in decentralized clinical trials. Such full-service, at-home monitoring could reduce patient attrition in clinical trials.

“Our customers are seeking solutions that will help them to add…

TE Connectivity beats the Street in Q1

TE Connectivity (NYSE:TEL) posted first-quarter results today that beat the consensus forecast on Wall Street.

The Schaffhausen, Switzerland-based company reported profits of $566 million — or $1.72 per share — on sales of $3.8 billion for the fiscal quarter ended Dec. 24, 2021, for a bottom-line gain of nearly 49% and sales growth of 8.4% compared with Q1 2020.

Adjusted to exclude one-time items, earnings per share were $1.76, 16 cents ahead of the Street, where analysts were looking for EPS of $1.60 on sales of $3.73 billion.

“We continue to experience a strong global demand environment and our first quarter sales growth was driven by strong sales performance in our Industrial and Communications segments,” TE Connectivity CEO Terrence Curtin said in a news release. “We also continue to benefit from the strategic positioning of our portfolio and investment in innovation that is focused on growth and sustainability trends in electric ve…

Smith+Nephew adds total hip arthroplasty to Cori surgical robot

Smith+Nephew (NYSE:SNN) today announced that it has expanded the indications on its Cori Surgical System to include total hip arthroplasty.

The London-based company previously designed the handheld robotic solution for total knee arthroplasty. The new indication with RI.Hip Navigation is designed to help maximize accuracy and reproducibility by delivering patient-specific component alignment to THA, according to the company.

“The addition of RI.Hip Navigation on the Cori System further strengthens Smith+Nephew’s Real Intelligence digital ecosystem and underscores our commitment to advancing clinical outcomes in total hip arthroplasty,” Randy Kilburn, EVP and general manager of reconstruction, robotics and digital surgery, said in a news release. “We look forward to offering the possibility of further improving patient outcomes and satisfaction to a broader surgeon community with the rapidly expanding adoption of our Cori Surgical System.…

Element Materials Technology acquired by Temasek

Element Materials Technology this week announced that it was acquired by Bridgepoint’s Temasek for an undisclosed amount.

Singapore-based Temasek has been a majority shareholder in Element since 2019. Element expects to accelerate its growth and build stronger positions in end-markets like life sciences and connected technologies, according to the company.

“The acquisition of Element by Temasek is a landmark transaction in the TIC sector, and a critical step in the development of the Group. We have grown from 20 locations and 600 colleagues ten years ago, to over 7,000 talented experts operating across 200 locations, and are ambitious to continue our rapid growth in the sector,” Element CEO Jo Wetz said in a news release. “Bridgepoint has been an exceptional partner, helping to support a ten-fold increase in our turnover over the past decade. We are delighted to expand our relationship with Temasek – their intimate understanding of…

Titan Medical receives final milestone payment from Medtronic

Titan Medical (TSX:TMD;OTC:TITFX) announced today that it received the final milestone payment under an agreement with Medtronic (NYSE:MDT).

Toronto-based Titan Medical confirmed the completion of the final milestone under a development and license agreement on Jan. 4 and announced today that, along with the payment, the senior secured loan from Medtronic as part of the agreement has been retired.

Medtronic provided Titan with a net payment of $8.3 million, comprised of a $10 million milestone payment related to achieving the final milestone and a $0.6 million payment related to certain legal, transaction and intellectual property costs. A portion of the $10.6 million gross total was used to retire the $2.3 million senior secured loan, which included the original note of $1.5 million, plus $0.6 million in additional costs and $0.2 million in interest, according to a news release.

The two companies entered into the development and license agreement in Jun…

Stevanato Group extends licensing agreement with Haselmeier for pen injector tech

[Image from Stevanato Group]Stevanato Group (NYSE:STVN) announced today that it signed an extension to a licensing agreement with Haselmeier over its pen injector technology.

Piombino Dese, Italy-based Stevanato Group’s license extension gives the company exclusivity to offer the Axis-D pen injector technology in support of a broader range of drugs for its biopharma customers beyond diabetes, including areas such as obesity, cardiovascular disease, gastrointestinal disorders, pain management, neurological disorder, arthritis and more.

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

Diagnostics, medical device sales power Abbott to Street-beating Q4

Abbott (NYSE:ABT) shares dipped slightly despite fourth-quarter results that topped the consensus forecast.

The Abbott Park, Illinois-based company posted profits of nearly $2 billion, or $1.11 per share, on sales of $11.5 billion for the three months ended Dec. 31, 2021, for an 8% bottom-line slide on sales growth of 7.2%.

Adjusted to exclude one-time items, earnings per share were $1.32, 11¢ ahead of Wall Street, where analysts were looking for sales of $10.7 billion.

The company’s diagnostics business, led by its BinaxNow rapid COVID-19 test, brought in the most revenue out of Abbott’s arms, with nearly $4.5 billion in sales. Medical devices saw massive year-over-year growth, rising 15.1% in revenues to more than $3.7 billion.

“2021 was an outstanding year for Abbott,” Abbott Chairman and CEO Robert B. Ford said in a news release. “We achieved more than 40 percent EPS growth, exceeding the baseline EPS guidance we …