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Stryker completes acquisition of Cerus Endovascular

Stryker (NYSE:SYK) + today announced it completed the acquisition of Cerus Endovascular. The financial details of the deal were not disclosed.

Cerus Endovascular designs and develops neurointerventional devices for the treatment of intracranial aneurysms. Cerus Endovascular’s CE marked products, the Contour Neurovascular system and Neqstent could assisted flow diverter, will expand Stryker’s portfolio of aneurysm treatment solutions.

Most recently, Cerus Endovascular was granted IDE approval from the FDA for a clinical trial of its Contour Neurovascular system in April. The company designed it with a fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. It self-anchors the system for stability and is re-sheathable for precise placement, and the sizing criteria are less restrictive because of the deployment across the neck. The system also received FDA breakthrough designation in …

TransMedics more than doubles revenue in Q1, raises guidance

TransMedics (Nasdaq:TMDX) shares rose this morning on first-quarter results that beat the consensus forecast.

Shares of TMDX ticked up 1.2% at $78.78 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.3%.

The Andover, Massachusetts-based organ transplant technology developer posted losses of $2.6 million. That amounts to losses of 8¢ per share on sales of $41.6 million for the three months ended March 31, 2023.

TransMedics posted a 75% bottom-line gain as it crept closer to breakeven. It more than doubled its sales from revenues of $15.9 million in the same period a year ago. The company attributed its growth primarily to National OCS (organ care system) Program (NOP) adoption in the U.S. That led to an increase in OCS Liver and OCS Heart sales.

Earnings per share came in 17¢ ahead of expectations on Wall Street, where analysts projected s…

Masimo trade secret suit against Apple ends in mistrial

Masimo’s W1 smartwatch [Image from Masimo]The ongoing patent spat between Masimo (Nasdaq:MASI) + and Apple has another twist as a federal judge declared a mistrial.

A federal judge in California made the ruling yesterday after jurors could not come to a unanimous verdict, according to a Reuters report.

A Masimo spokesperson issued the following statement following the ruling:

“While we are disappointed that the jury was unable to reach a verdict, we intend to retry the case and continue to pursue legal redress against Apple. As we begin that process, the United States Trade Commission is scheduled in the coming months to decide whether to ban the importation of certain models of the Apple Watch, following a ruling last year by an Administrative Law Judge that Apple infringed one of Masimo’s patents for pulse oximetry.”

Reuters reported that an Apple statement says the company …

Medical devices must comply with home healthcare safety and performance standards

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FDA clears Olympus endoscopy systems and endoscopes

Olympus’ Evis X1 endoscopy system [Image courtesy of Olympus]Olympus today announced it received FDA clearance for its new Evis X1 endoscopy system and two compatible gastrointestinal endoscopes.

The FDA clearance covers Olympus’ GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and the CF-HQ1100DL/I colonovideoscope indicated for use in the lower digestive tract.

Olympus’s GI endoscopy systems are used by physicians to help diagnose, treat and observe diseases and disorders of the upper and lower GI tract, such as acid reflux, ulcers, Crohn’s disease, Celiac disease and colorectal cancer. According to the company, one of the most common uses of an endoscope is for screening colonoscopy, during which a physician examines the lining of the colon and removes cancerous growths. Olympus’ new imaging technologies can help physicians visualize abnormalities.

“We are thrilled that we will soon …

Si-Bone grows sales 45% in Q1, raises full-year guidance

Si-Bone (Nasdaq:SIBN) + this week posted first-quarter results that beat the overall consensus on Wall Street.

The Santa Clara, California-based orthopedic company reported profit losses of $11.1 million, or 32¢ per share, on sales of $32.7 million for the three months ended March 31, for a bottom-line gain of 36.1% on sales growth of 45.76% compared with Q1 2022.

Earnings per share were 9¢ ahead of The Street, where analysts were looking for sales of $29.22 million.

“I am thrilled with our stellar start to 2023, as record procedure demand in the quarter allowed us to deliver approximately 50% U.S. revenue growth and achieve significant operating leverage,” CEO Laura Francis said in a news release. “The continued trend of accelerating revenue growth over the last several quarters is a testament to the perseverance and grit of our dedicated team members and the strong reception for our expanded portfolio of solut…

Fast Five: Medtronic’s next-gen leadless pacemakers, Casana’s smart toilet seat win FDA nods

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, May 2, 2023.

Fast Five by MassDevice · Medtronic’s next-gen leadless pacemakers, Casana’s smart toilet seat win FDA nods

Customized orthopedics is a growing trend in the medical device industry. Zimmer Biomet’s recent acquisition of Ossis underscores that trend toward personalized medicine. Fast Five hosts Danielle Kirsh and Sean Whooley give an inside look at the acquisition and how it will complement the orthopedic giant’s vast portfolio.

Chronic venous insufficiency (CVI) happens when a patient’s blood vessels in the lower limbs do not effectively pump blood back to the heart, causing valves in the leg veins to become damaged and less effective. Cook Medical wants to fix that. Whooley details the company’s initiation of its venous val…

Stryker boosts guidance — but perhaps not enough — after Street-beating Q1

Stryker (NYSE:SYK) + handily beat Wall Street expectations during its first quarter, though its guidance range increase may have disappointed investors.

The morning after Stryker’s earnings announcement, SYK shares were down more than 1% to $294.12 apiece. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up slightly.

The orthopedic and surgical device giant earned $592 million, or $1.54 per share, off of $4.78 billion for the quarter ended March 31, 2023. The bottom line was up 83.3%, and the top line was up 11.8% compared with the same quarter a year ago.

Adjusted to exclude one-time items, Stryker’s EPS was $2.14. The result was 14¢ ahead of The Street, where the analyst consensus was EPS of $2 and revenue of $4.56 billion.

“Demand remains strong for our products, and supply chain pressures are gradually improving,” CEO K…

Hologic beats The Street in Q2, raises guidance

Hologic (Nasdaq:HOLX) + today posted second-quarter results that topped the consensus forecast despite dipping COVID-19-related sales.

The Marlborough, Massachusetts-based women’s health and diagnostics company posted profits of $218.5 million. That amounts to 87¢ per share on sales of $1.03 billion for the three months ended April 1, 2023.

Hologic posted a 52% bottom-line slide on a sales decline of 28.5%. Significantly lower sales of COVID-19 assays — as expected — drove the declines. However, revenue still topped the company’s guidance range of $930 million to $980 million. Plus, excluding COVID-19-related revenues, total organic revenue grew by 20.2%.

Adjusted to exclude one-time items, earnings per share came in at $1.06. That landed 18¢ ahead of projections on Wall Street. Sales posted a beat, too, as analysts expected $958.8 in revenues.

Excluding COVID-19 sales, diagnostic revenues ticked up…

Masimo launches Stork at-home baby monitoring system

The Stork boot on a baby next to an image of the components of Stork. [Image courtesy of Masimo]Masimo (Nasdaq:MASI) announced today that it launched its Stork at-home monitoring system for babies.

Irvine, California-based Masimo designed Stork to offer parents insights into their baby’s health data. It could help them learn more about and be better connected with their baby, Masimo says.

“When we set out in 1989 to reinvent pulse oximetry, we named the project ‘Stork’ because our hope was that this technology would help reliably bring healthy babies home to their parents,” said Joe Kiani, founder and CEO of Masimo. “With Stork’s introduction today, we’ve taken our passion for newborn care and our innovative and groundbreaking technologies to craft a solution that we hope will give parents greater insights into their babies and help them live healthier lives. Parenting is the hardest thing one loves to do.

“With Stork, our goal is to improve the…

The growing influence of digital pathology in preclinical R&D: Spotlight on Proscia’s Concentriq

Proscia’s Concentriq for Research is an example of an advanced digital pathology platform.

As drug discovery evolves, digital pathology platforms are playing a vital role in streamlining preclinical R&D processes and accelerating drug discovery. Proscia‘s Concentriq for Research reflects this trend.

Earlier this year, we profiled PathAI’s AISight, a digital pathology platform designed to support AI-driven research. To learn more about Proscia’s digital pathology technology, we caught up with Nathan Buchbinder, co-founder and chief product officer at Proscia, who discussed how the Concentriq for Research digital pathology platform streamlines the preclinical R&D process and accelerates studies. In the following Q&A, he highlights the benefits of Good Laboratory Practice (GLP) compliance, the role of AI in unlocking new insights and how the platform facilitates collaboration…

May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons

Endolumik’s illuminated device takes a big step for safety

The top orthopedic device news out of AAOS 2023

SaMD development lessons from Cordio’s voice AI heart failure app

Orthopedic device tech advances

High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago.

Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay.

They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas.

In this edition of Medical Design & Outsourcing, Executive E…