News and Resources from the WTWH Media Life Science Network - Page 5 of 977

Dexcom stock slides despite Q1 beats, sales guidance increase

Dexcom (Nasdaq: DXCM) + shares took a hit after hours today on first-quarter results that came in ahead of the consensus forecast on Wall Street.

Shares of DXCM dipped about 7% to $128.40 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 1%.

The San Diego-based continuous glucose monitor maker reported profits of $146.4 million. That equals 36¢ per share on sales of $921 million for the quarter ended March 31, 2024. Dexcom more than tripled its bottom line on a sales uptick of 24.2%.

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

ResMed sees increased sleep device demand, stock rises on Q3 beats

ResMed (NYSE: RMD) + shares ticked up after hours on third-quarter results that came in ahead of the consensus forecast.

Shares of RMD rose more than 4% to $191 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 1%.

The San Diego-based respiratory device maker reported profits of $300.5 million. That equals $2.04 per share on sales of $1.197 billion for the quarter ended March 31, 2024.

ResMed recorded a 29.2% bottom-line gain on a sales increase of 7.2%.

Adjusted to exclude one-time items, earnings per share came in at $2.13. That landed 22¢ ahead of expectations on Wall Street. Sales also topped the forecast as experts estimated $1.17 billion in revenue.

The company attributed growth to increased demand for its sleep devices and growth acros…

Integer stock sinks despite Q1 beat as full-year forecast disappoints

Integer (NYSE: ITGR) + stock declined by 10% today despite posting Street-beating first-quarter earnings.

Investors were likely reacting to the medtech contract manufacturing giant’s full-year guidance, which was less than the analyst consensus.

Plano, Texas–based Integer earned $20.5 million, or 59¢ per share, off of $414.8 million in sales for the quarter ended March 29, 2024. Compared to Q1 2023, net income grew 57% and sales grew 9.5%.

Adjusted to exclude one-time items, Integer’s EPS was $1.14. The result was 3¢ ahead of The Street, where analysts on average expected EPS of $1.11 and revenue of $412.8 million.

“Integer started the year strong with first quarter 2024 sales growing 10% versus a year ago and adjusted operating income growing 26%, more than two and a half times the rate of sales growth,” Integer CEO Joseph Dziedzic said in a news release.

Integer said Card…

BCI maker Science acquires retinal implant from Pixium Vision

A rendering of the Prima System’s features, now acquired by Science. [Image from Pixium Vision]Brain-computer interface developer Science Corporation announced today that it acquired the IP and related assets for the Pixium Vision Prima implant.

Neuralink co-founder Max Hodak founded Science, which unveiled its Science Eye brain-computer platform in 2022. The Science Eye is a visual prosthesis. It targets retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), two forms of serious blindness.

The company now owns the retinal implant technology developed by Pixium Vision as well. France-based Pixium Vision said last fall that it was looking for a potential buyer.

The Prima System, a photovoltaic substitute of photoreceptors, already has FDA breakthrough device designation. It provides simultaneous use of the central prosthetic and peripheral natural vision. The company designed the implant for patients with atrophic dry age-related mac…

Demystifying deep learning: An accessible introduction to neural networks in health research and epidemiology

[Adobe Stock]

As machine learning and deep learning technologies advance thanks to advances in computation, algorithms and data availability, the possibilities of the technology continue to expand in medicine. While these AI-driven approaches have real potential, such systems demand large volumes of representative data, careful privacy and security scrutiny and thoughtful long-term strategic planning. In this Q&A, Kathryn Rough, associate director of the Center for Advanced Evidence Generation at IQVIA, discusses the impact of deep learning on healthcare delivery and recommends steps to take during the design, training, evaluation and deployment phases to increase the likelihood that these models will be safe, effective and ethical when trained on real-world health data. Rough also explores the role of epidemiologists in evaluating these technologies as part of multidisciplinary teams and provides advice for health…

Philips receives FDA warning letter over imaging systems manufactured in China

The FDA published a warning letter that it sent to Philips (NYSE: PHG) + that outlines issues around imaging technology manufacturing practices.

During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations in the manufacturing of the computed tomography (CT) systems on Feb. 23, 2024.

The devices are adultered in that the methods used in, or the facilities or controls used for their manufacture, storage or installation are not in conformity with current good manufacturing practices, the FDA said.

According to the FDA, Philips Head of Quality for the plant, Xin Li, responded to the inspection’s findings on Nov. 17, 2023, and Dec. 18, 2023.

This latest regulatory setback for Philips follows the long-running saga arou…

Boston Scientific warns on some Vercise Genus implantable pulse generators

The Vercise Genus DBS system [Image from Boston Scientific]Boston Scientific (NYSE: BSX) + recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators.

In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. Boston Scientific said the reset behavior occurs in response to the presence of potential interference during IPG charging. The IPG reset behavior is random and remote. Patients with devices exhibiting this reset behavior may not report any discernible impact.

Boston Scientific received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Upon investig…

Fresenius Medical Care recalls more than 2 million catheter components

The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind.

Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March 5, 2003, and Jan. 25, 2024. To date, the company reports no injuries or deaths related to the recall.

The sets and adapters connect peritoneal dialysis catheters to peritoneal dialysis systems. They are indicated for patients with acute and chronic end-stage kidney (renal) disease. These patients undergo peritoneal dialysis at health care facilities or in home settings.

Fresenius Medical Care issued the recall to correct the instructions for use. The company found non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching in the peroxide-cross linked silicone tubing. These compounds can enter a patient’s peritoneal…

BD warns on some neXus V700 infusion pumps outside the U.S.

BD (NYSE: BDX) + issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system.

According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The issue does not affect to Alaris systems in the U.S.

Free flow as a result of this issue may result in over-infusion. Damage to the pump-based free flow mechanism may not be apparent to the user. Depending on the medication in progress at the time of the free flow, BD says it’s reasonable to expect that an imminently life-threatening situation may arise as a result of the issue.

To date, the company reports one adverse event related to the issue with its neXus V700 infusion pump.

BD reported the issue and advises that clinicians remove the infusion pumps from clinical use with immedia…

May 2024 edition: Intuitive’s DV5, pediatric device design and diabetes tech

The Intuitive da Vinci 5’s top design changes: ‘This is groundbreaking for robotic surgery’ Small patients, big design challenges: Pediatric device experts guide engineers on solutions The biggest diabetes tech news out of ATTD 2024 5 things that will shape surgical robotics over the next decade All eyes on Intuitive’s da Vinci 5

It’s hard to think of a product update with higher stakes for a device developer — and the medtech industry — than Intuitive Surgical’s da Vinci 5 robotic-assisted surgery system.

All eyes are on the world’s leading surgical robotics developer as it rolls out the next generation of its flagship system after winning FDA clearance. Will the new features and long list of design changes put even more distance between surgical robotics and conventional laparoscopy? Is Intuitive advancing its technology rapidly enough to maintain or expand its lead ahead of larger device manufacturers, maturing surgical robotics developers and fas…

FDA says InfuTronix infusion pump recall includes 1 death

The Nimbus infusion system. [Image from InfuTronix]The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death.

Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues with the Nimbus infusion pump systems was related to one user death.

InfuTronix said it found multiple potential failure modes that may include battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate or damaged housing. The company also reports 3,698 complaints as a result of the issues and six serious injuries. InfuTronix won’t offer or support the devices after June 20, 2024.

Using affected pumps could cause infection from microbial contamination after loss of the sterile barrier (leakage). It could also lead to interruptions or delays …

FDA labels Outset Medical recall of Tablo hemodialysis system as Class I

[Image from Outset Medical]The FDA today labeled Outset Medical’s recall of some Tablo hemodialysis devices as Class I, the most serious kind.

The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA.

Outset Medical (Nasdaq: OM) + recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching was identified at levels above allowable safety limits. Peroxide-cured silicone tubing in the machines’ hydraulics and dialysate lines caused the unsafe NDL-PCBAs levels.

The dialysate solution may expose patients to higher than allowable limits. According to the FDA, Outset Medical determined that leaching NDL-PCBAs decreases over time and will reduce to an acceptable safety level after 336 hours of console operational use.

Exposure to NDL-PCBAs and NDL-PCBA-related comp…