The company’s notice said it decided to proactively recall a batch combination of the syringes. B. Braun identified a number of batches of its Exadoral, Henke-JECT, Norm-Ject and Injekt devices.
In the course of postmarket surveillance and internal quality checks, the company identified the reason for the recall. For a subset of the batch combinations, the sterile packaging barrier may be damaged.
Get the full story at our sister site, Drug Delivery Business News.
Access Vascular this week announced positive results from a study of its HydroPICC catheter.
Billerica, Massachusetts-based Access Vascular designed the device to help reduce the most common and costly complications that are associated with vascular access procedures, including infection, thrombosis and phlebitis. The HydroPICC is constructed of a hydrophilic biomaterial with Mimix technology.
A peer-reviewed study of the HydroPICC peripherally inserted central catheter (PICC) demonstrated positive results that showcased the benefits of the catheter in reducing clot formation and failures when compared to conventional polyurethane PICCs.
As part of the study, 121 patients received a PICC as part of their medical care. The study demonstrated no occlusions or replacements in the 60 HydroPICC insertions, while 13 catheter occlusions were reported in the 61 polyurethane insertions catheter group and eight outright PICC replacements (13%).
“Reducing cl…
DarioHealth (Nasdaq:DRIO) announced today that a new analysis demonstrated a significant cost reduction for users of its digital therapeutic platform.
Sanofi U.S. conducted the analysis, which showed lower costs of care for DarioHealth users compared to non-users with type 2 diabetes. The study used matched claims to show an estimated $5,077 in medical cost savings for the DarioHealth users.
Get the full story at our sister site, Drug Delivery Business News.
Launched in the U.S. in April 2022, the Amplatzer sheath delivers Abbott’s Amplatzer Amulet left atrial appendage occluder. Competing against Boston Scientific’s Watchman, Amplatzer Amulet provides complete occlusion in order to reduce the risk of ischemic stroke among people with atrial fibrillation.
Abbott, in June, initiated a recall of model No. ASDS-14F-075 of the sheath — 672 devices distributed in the U.S. between Oct. 4, 2022, and Feb. 22, 2023 — because there is an increased risk for the introduction of air bubbles (air emboli) into patients who have procedures with this device, according to the FDA.
The company reports 26 incidents, 16 injuries, and no deaths related to this issue.
Abbott is asking health providers to return any remaining unuse…
Medtech supplier TE Connectivity (NYSE: TEL) today released financial results for its fiscal Q3, falling short of analysts’ sales expectations but exceeding expected earnings.
Schaffhausen, Switzerland-based TE Connectivity said medical market performance in its industrial segment continues to improve. The company provides connectivity and sensor solutions for medical applications and a broad range of other industries.
“We delivered earnings above guidance, along with year-over-year sales growth in our Transportation and Industrial segments, as we continue to benefit from the strategic positioning of our portfolio around key growth and sustainability trends,” TE Connectivity CEO Terrence Curtin said in a news release. “Our leading global position in electric vehicles once again allowed us to deliver a strong performance in Transportation, and we continued to capitalize on growth momentum in renewable energy applications as well as ongoing market rec…
AtriCure (Nasdaq:ATRC) shares rose today on second-quarter financial results that came in ahead of the consensus forecast.
Shares of ATRC ticked up 5.2% at $55.94 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — increased slightly.
The Mason, Ohio-based cardiovascular care company posted losses of $5.1 million. That equals 11¢ per share with sales of $100.9 million for the three months ended June 30, 2023.
AtriCure reported a 65.5% bottom-line gain closer to breakeven on sales growth of 19.4%.
Adjusted to exclude one-time items, losses per share came in at 12¢. That put AtriCure 17¢ ahead of projections on Wall Street, where analysts expected sales of $97.5 million.
The company attributed its revenue growth to U.S. sales in all key product lines. That includes the EnCompass clamp for open ablation, cryoSPHERE probe for post-operative pain man…
LivaNova (Nasdaq: LIVN) + shares are on the rise today on second-quarter results that came in ahead of the consensus forecast.
Shares of LIVN ticked up 8.3% at $58.04 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even.
The London-based medtech company posted profits of $1.2 million in the quarter. That equals 2¢ per share on sales of $293.9 million for the three months ended June 30, 2023.
LivaNova recorded a 92.7% bottom-line slide while achieving sales growth of 15.6%.
Adjusted to exclude one-time items, earnings per share came in at 78¢, landing 24¢ ahead of Wall Street projections. Sales also beat expectations, with analysts forecasting $265.5 million in revenue.
LivaNova saw the largest revenue growth in its cardiopulmonary business, which rose by 19.7% year-over-year. That also r…
Teleflex (NYSE: TFX) + announced today that it entered into a definitive agreement to acquire Palette Life Sciences.
The deal to acquire the privately-held urology technology developer includes an upfront cash payment of $600 million at closing. It also includes up to an additional $50 million upon the achievement of certain commercial milestones.
Wayne, Pennsylvania-based Teleflex said in a news release that it expects to complete the acquisition in the fourth quarter of 2023. The company believes Palette’s offerings expand its interventional urology portfolio, which includes the UroLift system.
Palette develops a non-animalized stabilized hyaluronic acid (NASHA) spacer and tissue bulking products. The company estimates standalone revenues of approximately $56 million in 2023. Assuming a Dec. 1, 2023, closing, Teleflex does not expect the acquisition to significantly impact its revenue for the year.
<…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, July 26, 2023.
Fast Five by MassDevice · 3M to name CEO for Health Care spinoff, Baxter names its proposed kidney care spinoffGE HealthCare’s strong Q2 performance and raised guidance signal a positive outlook for the company. The standalone GEHC should benefit from a number of underlying growth drivers in the future as well. Fast Five hosts Sean Whooley and Danielle Kirsh explain what factors contributed to the company’s growth and how analysts view performance and prospects.
NeuroOne Medical Technologies recently announced it priced an underwritten registered public offering. The proceeds from the offering may accelerate NeuroOne’s research and development efforts. Find out the size of the offering and how NeuroOne plans to use the funds in today’…
This rendering shows Lura Health’s saliva sensor in a retainer [Image courtesy of Lura Health]
Being in China when COVID-19 hit might not seem like a stroke of good luck, but it paid off for Lura Health’s sensor miniaturization efforts.Without a physical presence in Shenzhen, the minature sensor startup might not have been able to line up a battery supplier willing to take on the demanding needs of Lura Health’s saliva sensor, said co-founder and CEO Daniel Weinstein.
“Supply chain right now is super difficult. Vendor agreements are pretty crazy. [Just about] every PCBA house in the country is backed up with a huge backlog,” Weinstein said in an interview with Medical Design & Outsourcing.
“Our strength as a company is trying to find ways to beat the odds that are against companies — especially startups — in this industry,” he continued. “WeR…
A rendering of Lura Health’s saliva sensor with a U.S. penny for scale [Image courtesy of Lura Health]
Lura Health has developed a tiny, wireless oral sensor for saliva monitoring to track acidity and much more in the years ahead.The company aims to start by noninvasively measuring saliva acidity to help prevent tooth decay, which is the most prevalent health condition globally and the most common chronic disease in children and young adults.
“It affects at some point around 90% of Americans,” Lura Health co-founder and CEO Daniel Weinstein said in an interview with Medical Design & Outsourcing. “There’s a population set for which it imposes a huge burden. And dental expenditures are $162 billion or more in the U.S. alone, so it’s a big economic and health toll.”
Weinstein founded the company in 2017 with Chief Medical Officer Dr. Saam Bozorg and Chie…
As the number and types of connected medical devices rises, so does the risk to their safety. Constant threats from a widening collection of contributors have compelled manufacturers to view security as a core product attribute, including:
Protecting devices from external attacks such as viruses, worms and ransomware Protecting confidential patient data Updating devices securely when issues are found post-releaseIn addition, technology trends such as the adoption of Linux and complex innovations like AI and machine learning, advanced graphics, voice control and multicore architectures are quickly driving evolution throughout the life-sciences industry.
Siemens Connected Care software reliability tools cover open-source Linux and Android, and proprietary real-time operating systems (RTOS) complemented by a complete development tool suite and large partner ecosystem.
Download the whitepaper from Siemens Digital Industries Software to learn more
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