Real-world evidence use is expanding. What’s behind the change?

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In the rapidly evolving landscape of drug development, real-world evidence (RWE) is making significant strides, finding its way into the early stages of the process. No longer confined to just the peri- and post-approval phases, RWE is now being tapped for external control arms (ECAs), aiding in health technology assessment (HTA), and informing payer discussions.

To maintain their competitive edge, biopharma executives need to develop a comprehensive early data strategy, noted executives from Evidera, part of the PPD clinical research business of Thermo Fisher Scientific, in a recent Q&A. This strategy should focus on carefully selecting and effectively harnessing real-world data (RWD) to support regulatory and HTA approvals.

The use of RWE, however, is not without challe…

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Artivion has positive heart valve data

The On-X aortic heart valve. [Image from the Artivion website]Artivion (NYSE:AORT) today announced positive outcomes from a post-market study of its On-X aortic heart valve.

The company shared five-year real-world safety and efficacy data demonstrating even better outcomes than predicted by a previous study. Other data highlighted positive aortic remodeling outcomes as well and zero distal anastomotic new entry (DANE) tears.

Artivion’s five-year study of 229 participants showed a significantly lower composite primary endpoint of thromboembolism, valve thrombosis and major bleeding (1.83%) compared to the pre-defined historic control rate of 5.39%. It included an 87% reduction in major bleeding and no increase in thromboembolism. The study compared subjects to a historic control group of standard-dose warfarin.

According to Artivion, its real-world interim results show safety and efficacy with low-dose warfarin.

“The long-term data continu…

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First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks

The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that’s unique within Medtronic’s PFA device portfolio.

The Medtronic Sphere-360 pulsed field ablation catheter is adjustable, allowing it to take different shapes inside a patient. [Illustration courtesy of Medtronic]

Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world’s largest device manufacturer.

In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac Ablation Solutions, discussed the Sphere-360’s design and features.

The large-lattice, over-the-wire PFA Sphere-360 catheter — which Medtronic purchased through its acquisition of Affera — is investigational in the EU …

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ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory

The ClearPoint Prism neuro laser therapy system. [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory.

It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January.

The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows.

ClearPoint Neuro designed its Prism bone anchor accessory for use with commercially available stereotactic systems. These systems work for intracranial and neurosurgical procedures. Such procedures require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain or nervous systems.…

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Sight Sciences to earn $34M from Alcon patent infringement suit

Sight Sciences (Nasdaq:SGHT) announced today that it received a jury trial verdict awarding it $34 million from a patent infringement case against Alcon.

The company filed the case on Sept. 16, 2021, against Alcon, Alcon Vision, Alcon Research and Ivantis (collectively Alcon) in the U.S. Menlo Park, California-based Sight Sciences asserted that Alcon’s sale of the Hydrus Microstent infringed three key patents.

Alcon developed the Hydrus Microstent as a microinvasive glaucoma surgery (MIGS) device. Roughly the size of an eyelash, the canal-based nitinol device treats open-angle glaucoma. Sight Sciences develops the Omni implant-free MIGS system.

Following a five-day trial, the jury found that Alcon willfully infringed on the three patents, according to a news release. The verdict, handed down on April 26, awarded monetary damages for the infringements. Damages include $5.5 million in lost profits and $28.5 million in royalty damages for sales of the…

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FDA issues warning letter to Cardinal Health for adulterated and misbranded medical devices

The FDA recently issued a warning letter to Cardinal Health (NYSE: CAH) + following an inspection at one of its facilities.

The inspection revealed unapproved device violations pertaining to the Monoject Leur-lock tip syringes and the Monoject Enteral Feeding Syringes, as well as quality system regulation violations.

Dublin, Ohio-based Cardinal Health was found to be marketing convenience kits containing certain piston syringes manufactured by Jiangsu Shenli Medical Production Co. without appropriate FDA approvals. The FDA deemed the device adulterated and misbranded under various Federal Food, Drug, and Cosmetic Act sections.

According to the warning letter, syringes with different technological characteristics in the kits posed risks to patient safety, including dosing and device leakage.

Quality system regulation violations led to a recall

Cardinal Health’s quality system regulation violations inc…

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BCI maker Blackrock Neurotech picks up $200M investment from cryptocurrency company

Neuralace visually looks like a piece of lace. It is thinner than an eyelash. It’s possible to engineer it with a variety of materials and patterns, and it can go on wide swaths of the brain’s surface. [Image courtesy of Blackrock Neurotech]Tether, a digital asset industry leader, announced today that it made a $200 million strategic investment in Blackrock Neurotech.

With the investment — made through a newly formed venture division called Tether Evo — Tether is now the majority stakeholder in Blackrock Neurotech, a maker of neurotechnology such as brain-computer interfaces (BCIs).

Blackrock Neurotech develops the NeuroPort Array neural interfacing system. The system, used in human BCIs since 2004, helped patients regain tactile function, movement of limbs and prosthetics and the ability to control digital devices. They can achieve this despite diagnoses of paralysis and other neurological disorders.

The company said next-generation BCIs could extend…

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FDA clears new patient monitor from GE HealthCare

The Portrait VSM vital signs monitor. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + announced today that it received FDA 510(k) clearance for its Portrait VSM vital signs monitor.

Portrait VSM provides clinicians with an accurate view of patient vital signs to support timely clinical decisions. It utilizes the SuperSTAT non-invasive blood pressure algorithm to provide precise and accurate measurement readings. Through wireless connectivity and seamless EMR integration, the monitor centers around workflow efficiency. It offers customized early warning scores (EWS) and enables care teams to focus on patient care by automating routine tasks.

The system builds on the GE HealthCare family of Portrait monitoring solutions. It can connect with the latest iteration of the Portrait Mobile wireless, wearable continuous monitoring system as well. Using a single click of a barcode scanner, Portrait VSM automatically…

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Philips stock skyrockets on positive outlook, $1.1B Respironics settlement in spite of Q1 misses

Philips (NYSE: PHG) + shares got a huge boost today despite first-quarter results that fell shy of the consensus forecast on Wall Street.

Investors appeared to react positively to recent updates on the company’s long-running Respironics recall. Shares of PHG rose more than 35% to $28.50 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 0.5%.

The company’s recent progress with its ongoing Respironics recall included agreeing to a consent decree in the U.S. and receiving a judge’s approval to settle lawsuits related to the economic losses involving millions of recalled CPAP machines. (The economic losses settlement — not to be confused with personal injury claims — was for at least $613 million. Here’s a full timeline of the recall going back to mid-2021.)

Philips said today that it settl…

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Abbott wins FDA approval for dissolving drug-eluting scaffold

The Esprit everolimus-eluting scaffold. [Image from the Abbott website]Abbott (NYSE: ABT) + announced today that the FDA approved its Esprit everolimus-eluting resorbable scaffold system.

The Esprit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving.

Abbott says that before this approval, there were no stents or drug-coated balloons to treat below-the-knee chronic limb-threatening ischemia in the U.S.

The current standard of care, balloon angioplasty, relies on a small balloon delivered via a catheter. It compresses against the arterial wall, opening the blood vessel and restoring flow.

However, Abbott said blockages treated only with this method have poor short- and long-term results. Many cases result in the vessels becoming blocked again, requiring additional…

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Navigating the intersection of technology and human expertise in life sciences

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In this age of rapidly evolving technologies that fundamentally shift the way businesses operate, such as large language models (LLMs) and natural language processing (NLP), organizations are quickly realizing that success extends beyond innovative technology solutions alone. While these technologies offer immense potential in terms of innovation, data insights and operational efficiency gains, constraints exist in areas such as meeting regulatory requirements, managing data availability/ date volume/ data congruence and, in some cases, ensuring commercial viability. These limitations must be addressed for successful adoption across the healthcare industry and for implementation of such tools into broad based quality management systems and product solutions.

True success hinges on the effective implementation and strategic utilization of technology, guided by human expertise and supported by well-designe…

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The 25 best-funded private healthcare and biotechnology companies of all time: From Altos to Theranos and beyond

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In early 2022, secretive Altos Labs stunned with a record $3 billion launch to pursue anti-aging “cellular rejuvenation” amid rumors of Jeff Bezos’ backing.

But a roundup of the 25 private healthcare and biotech companies that raised the most money in recent decades reveals a landscape of grand ambitions to disrupt healthcare. There are also some cautionary tales.

Included in the mix is scandal-plagued and now-liquidated Theranos, which raised a total of $1.4 billion in the early 2000s from prominent investors by fraudulently claiming to have game-changing blood testing technology.

Another company facing scrutiny is Devoted Health, a Medicare Advantage insurer that raised $1.9 billion aiming to reinvent senior care through technology and patient-centered approaches. STAT, however, noted that the company has yet to turn a profit after five years. And then there is Grail, wh…

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