Akeso, a ruggedized version of Bexson Biomedical’s wearable infusion device, utilizes Sevalent technology. Sevalent, Bexson’s proprietary formulation platform can work with small molecules across a broad range of drug classes. It enables subcutaneous intravenous (IV) therapy delivery.
Bexson management believes Akeso can provide rapid ketamine-based pain relief to soldiers in contested environments.
Get the full story at our sister site, Drug Delivery Business News.
Franklin MA, July 2023 – Eagle Stainless Tube & Fabrication, a leading small diameter stainless steel tubing supplier, is proud to announce the successful renewal of its ISO 13485:2016 and ISO 9001:2015 quality management certifications. Eagle has been maintaining ISO quality certifications since 1998, spanning 25 years! This achievement reflects the company’s unwavering commitment to maintaining the highest standards in quality management systems for medical devices and related services.
ISO 13485 and ISO 9001 are internationally recognized standards that set requirements for the development, production and distribution of medical devices. By adhering to this rigorous specification, Eagle Stainless ensures that its products and services consistently meet our customer’s …
Shares of RBOT fell 2.9% to $1.69 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even.
The company failed to beat Wall Street expectations but shared good news on the regulatory process for its surgical robot platform. Vicarious Surgical’s approach uses proprietary human-like surgical robots. It transports surgeons inside the patient to perform minimally invasive surgery.
In April, Vicarious completed a design freeze for its Version 1.0 (V1.0) system. Integration and the build of system units remain on track for fall 2023.
Having received some input from the FDA, Vicarious Surgical expects to begin first-in-human trials in mid-2024. The c…
The FDA issued a notice labeling the GE HealthCare (Nasdaq: GEHC) + SpO2 sensor recall as Class I, the most serious kind.
GE HealthCare initiated the recall of nine models of its TruSignal SpO2 sensor on May 19, 2023. The recall includes 7,559 devices distributed between Jan. 1, 2021, and March 4, 2023.
TruSignal sensors continuously monitor the amount of oxygen found in the blood flowing through the arteries and pulse rate. Placed on the skin, the sensors help to ensure that patients have enough oxygen in their blood to continue functioning. They also help care providers garner information necessary to make treatment decisions.
Why GE HealthCare recalled the sensorsGE HealthCare recalled malfunctioning TruSignal sensors that may reduce the amount of energy sent to the heart during defibrillation. This issue occurs without any notification to the care provider. Without notification, this could prevent the deliv…
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 28, 2023.
Fast Five by MassDevice · Boston Scientific invests $170M to expand operations, Baxter’s BPS divestiture faces uncertaintyPhilips’ collaboration with CoxHealth showcases the growing importance of virtual care solutions in the post-COVID era. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the aim of the collaboration and some of the feedback and reactions from clinical staff about the virtual care delivery program.
Asensus Surgical’s $10M offering indicates its efforts to secure financial resources for expanding its surgical robotics technology and bringing its innovative products to a broader market. Find out how Asensus plans to use the funds and what is included in the offering in today’s episode.
The positive data …
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The journey to developing a successful drug, theoretically, may appear linear: you discover the right drug, find the suitable patient and administer it at the right time. The reality, however, often deviates from this straightforward path. Aligning these three variables remains notoriously difficult, often leading to elongated timelines strewn with failures, sometimes extending over a decade with costs often in the billion-dollar range.In recent years, the use of AI in drug discovery and development has grown swiftly, marking a significant shift in how we understand, discover and develop new drugs. The technology promises to chip away at timelines and save the industry billions of dollars eventually. But those promises aren’t exactly new. Even before ChatGPT became popular, many drug developers were working with high-end algorithms to “try to really hone in on databases,” said Andrew…
Publicly traded medical device manufacturers such as Medtronic, Johnson & Johnson, Abbott and Stryker will need to publicly disclose significant cyberattacks under new rules approved by the Securities and Exchange Commission.
The SEC rules require all publicly traded companies — not just device makers — in the U.S. to release details of a cyberattack within four days of determining that it has a material impact. That determination comes down to whether “there is a substantial likelihood that a reasonable person would consider it important,” the SEC has said.
Related: The Medtech Big 100 ranks the world’s largest medical device companies
“Whether a company loses a factory in a fire — or millions of files in a cybersecurity incident — it may be material to investors,” SEC Chair Gary Gensler said in a statement. “Currently, many public companies provide cybersecurity disclosure to investors. I think companies and investors alike, howe…
Dexcom (Nasdaq:DXCM) shares ticked up after hours on second-quarter results that topped the consensus forecast.
Shares of DXCM rose 2.3% at $132.35 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.6%.
The San Diego-based continuous glucose monitor (CGM) maker posted profits of $115.9 million. That equals 28¢ per share on sales of $871.3 million for the three months ended June 30, 2023.
Dexcom more than doubled its profits on sales growth of 25.2%.
Get the full story at our sister site, Drug Delivery Business News.
Medtech contract manufacturing giant Integer (NYSE:ITGR) + saw its stock rise more than 7% today on Street-busting second-quarter results.
Plano, Texas–based Integer earned nearly $24 million, or 71¢ per share, off of $400 million in revenue for the quarter that ended June 30, 2023. The bottom line was up 15%, and the top line rose 14% compared with Q2 2022.
Adjusted to exclude on-time items, Integer had earnings per share of $1.14. The result was 14¢ ahead of the expectations of Wall Street analysts, who on average predicted adjusted EPS of $1 on sales of $367.06 million.
“Integer delivered another strong quarter of sales and profit growth supported by an improving supply chain and labor environment,” Joseph Dziedzic, Integer’s president and CEO, said in a news release. “As we continue to see strong customer demand across our product lines, we are increasing our full-year sales outlook to 12% growth at the midp…
According to a report in Europe, a Paris, France, court found that Medtrum’s latest insulin pumps infringe an Insulet (Nasdaq:PODD) patent.
JUVE Patent reported that earlier this month, the Judicial Court of Paris declared the infringement. The court found that Medtrum’s newest pump base and patch reservoir models violate the EP2438957B1 patent from Insulet.
In declaring the infringement, the court ordered Medtrum to recall its Nano TouchCare pumps sold in France. Patients already using the device received an exemption.
Get the full story at our sister site, Drug Delivery Business News.
The capital infusion aids the company’s commercialization efforts for its AI-driven surgical navigation platform in the U.S. and overseas.
Seattle-based Proprio designed its Paradigm surgical navigation platform to replace traditional surgical navigation technologies. Using an advanced approach, it avoids the pitfalls that pull attention away from the patient and disrupt workflows. FDA cleared Paradigm in April.
The system uses light field technology and AI to generate a real-time, 3D visualization of surgery. It provides surgeons with the Proprio Volumetric Intelligence, which combines medical images with live data from Paradigm’s sensor suite.
Proprio says its Paradigm system eliminates the need for intraoperative scans, reducing radiation exposur…
The FDA today released draft guidance for developers of devices meant to treat opioid-use disorder.
The agency cited the specific challenges of designing clinical studies to evaluate these devices, including inaccurate self-reporting of drug use, missing data, the confounding effects of related drug treatments and the lengthy observation periods needed to demonstrate therapeutic.durability.
For example, the FDA said pivotal device studies to support marketing submissions “should have a well-defined study population, appropriately monitor drug use, control for bias and include an appropriate follow-up period, study participant retention plans and data analysis plans.”
Related: Could minimally invasive neuromod tackle the opioid epidemic?
The FDA wants feedback on the draft guidance to review before finalization. The agency said the guidance doesn’t apply to diagnostics for opioid use or opioid use disorder, combination products, o…