Psilocybin analog leads to 79% of remission in mid-stage depression trial

After only two doses, nearly eight out of ten participants in a phase 2 trial experienced remission from major depressive disorder (MDD) at six weeks, highlighting the potential of Cybin’s deuterated psilocybin analog, CYB003.

In 2021, an estimated 21.0 million adults in the United States had at least one major depressive episode, representing 8.3% of all U.S. adults, according to NIH.

While estimates vary for remission rates with traditional antidepressants, one study found a remission rate of 37% after the first treatment and 31% after the second. Traditional antidepressants also have the disadvantage of being slow acting, often taking 6 to 8 weeks before a detectable effect is observable. Complicating matters further is that patient adherence to traditional antidepressant therapy often remains poor with one study showing that 50% or more of patients fail to take antidepressants as prescribed. Another review found that 28% of patients stop antidepressan…

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Johnson & Johnson MedTech enters LAA device space with acquisition of Laminar

Johnson & Johnson MedTech announced today that it completed the acquisition of left atrial appendage (LAA) device maker Laminar.

The deal, which includes a $400 million upfront payment, adds Johnson & Johnson MedTech to the crowded LAA device space. Established devices like Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman already exist within the market. Medtronic threw its hat in the ring with the launch of its Penditure LAA exclusion system this week.

However, unlike these technologies, which exclude or occlude the LAA, Laminar’s aims to completely eliminate it to treat AFib. Rather than use catheter-based devices to plug and occlude the LAA, Laminar’s approach utilizes rotational motion. The company recently received FDA approval to begin a U.S. pivotal study, earmarked to start enrollment in early 2024.

“For the millions of people living with AFib, stroke risk is a major concern. The team at Laminar is driven…

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Fast Five: FDA warns of thermal issues with Philips DreamStation 2 CPAP machines

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, November 30.

Fast Five by MassDevice · FDA warns of thermal issues with Philips DreamStation 2 CPAP machines

Zilia this week won an FDA 510(k) clearance for a retinal camera. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the retinal camera is designed for, how it works and what’s next for the company.

ReValve reported one of the first successful first-in-human implants for its next-gen transcatheter mitral valve replacement. Hear about the procedures and what doctors thought about using the valve replacement.

BiVacor received investigational device exemption from the FDA to begin feasibility studies of its artificial heart. Whooley details the technology that goes into the artificial heart and some of the plans behind the upcoming studies.

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Medtronic reports first patient treated with Symplicity Spyral renal denervation system

The Medtronic Symplicty Spyral renal denervation ablation catheter expands inside the renal arteries and ablates nerves in the vessel wall to treat hypertension. [Illustration courtesy of Medtronic]Medtronic (NYSE: MDT) + announced that doctors completed the first commercial case in the U.S. with its Symplicity Spyral renal denervation (RDN) system.

Also known as the Symplicity blood pressure procedure, Symplicity Spyral treats high blood pressure, or hypertension. The first procedure follows the landmark approval for the system earlier this month.

Approval made Medtronic the second company with such approval, following Recor Medical’s nod earlier this month. There had previously been question marks over whether the medtech giant would receive approval after an FDA panel voted that the Spyral system’s risks outweighed its benefits.

However, the now-approved system was used in the first procedure at Piedmont Atlanta…

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50 of the best-funded biotechs of 2023

[Adobe Stock]

As the year draws to a close, it is clear that molecular science and diagnostics is the hottest funding area in the biotech industry. In an analysis of 50 of the best-funded biotechs of 2023 focused on human health, molecular and science and diagnostics startups collectively attracting roughly $945 million, dwarfing the figures in other segments. The next popular two niches, gene therapies and oncology, had average funding levels of approximately $245 million and $170 million, respectively. While AI has received a significant amount of attention this year, biotechs specializing in that field garnered an average funding of only about $66 million. Outside of the life sciences, startups with a broader focus on AI raised a cumulative average of $202.47 million, based on an analysis of close to 1000 companies.

Caris Life Sciences has raised nearly $1.7B to date

In terms of best-funded companies overall,…

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Moticont releases 0.875-in. diameter linear voice coil servo motor

NEWS RELEASE: Linear Voice Coil Servo Motor Just 0.875 in. in Diameter Has High Force-to-Size High Acceleration, and a 0.25 in. Stroke!

The Moticont GVCM-022-013-01 Linear Voice Coil Servo Motor [Image courtesy of Monticot]

Van Nuys, CA – Moticont has released the GVCM-022-013-01 Linear Voice Coil Servo Motor. This compact .875 in. (22.2 mm) diameter high speed, high force-to-size linear motor features high accuracy and high repeatability when operated in a closed loop as a DC servo motor.  This brushless servo motor is clean, quiet and has long life, low mass and high acceleration/deceleration for high throughput.  This linear voice coil motor, also known as a moving coil motor or actuator is ideal for: Haptic feedback, medical devices, wafer handling, optical focusing, dynamic vibration absorption, work holding and clamping, assembly, testing, positioning, scanners, laser beam steering, laser speckle correctio…
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AWS expands collaborations with Amgen and Merck to advance AI in drug discovery and manufacturing

[Adobe Stock]

At its annual re:Invent event, Amazon Web Services (AWS) announced expanded alliances with two leading drug developers, Amgen and Merck, to create generative artificial intelligence (AI) technologies aimed at accelerating drug discovery and increasing efficiencies in manufacturing processes.

Merck has been working with AWS and Accenture for several years whereas Amgen and AWS have collaborated for more than a decade.

Reflecting on AWS’s presence in the life sciences, Dan Sheeran, general manager of healthcare and life sciences at AWS, noted the company works with thousands of global healthcare and life sciences customers, including nine of the top 10 pharma companies.

“Healthcare and life sciences organizations are increasingly turning to AWS and technology as a business differentiator—especially with the explosion of generative AI,” Sheeran said. “Our pharma c…

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Novo Nordisk to boost GLP-1 capacity with €2.1 billion investment in France

Novo Nordisk announced last week that it plans to invest approximately 16 billion Danish kroner €2.1 billion in GLP-1 drug production.

The company plans to expand its Chartres, France, production site for its current and future product portfolio within serious chronic diseases. This investment significantly increases the capacity of the manufacturing site. It adds aseptic production and finished production processes and extends its current quality control laboratory.

Denmark-based Novo Nordisk’s investment doubles the footprint of the existing plant. It began construction projects and expects finalization between 2026 and 2028, with more than 500 new jobs set to come along with it.

The company said its investment ups the capacity for GLP-1 products and will help it meet future demands for innovative medicine.

GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and weight loss. This therapeutic class, a glucagon-lik…

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Wearable developer Empatica aims to develop new digital biomarkers

Empatica Chief Medical Officer Dr. Marisa Cruz discusses advances in wearable technology and how new digital biomarkers could advance medtech.

Empatica Chief Medical Officer Dr. Marisa Cruz [Photo courtesy of Empatica]

Dr. Marisa Cruz envisions a future where unobtrusive wearable devices with advanced sensors will continuously measure and record actionable biodata without patients having to lift a finger.

Cruz is an endocrinologist and internist who serves as chief medical officer at Empatica, which develops wearable devices for monitoring patient physiology with the ultimate goal of improving clinical outcomes.

In 2011, Empatica spun out of an MIT lab focused on wearable sensors for continuous, passive patient monitoring. That technology is made possible by ever-shrinking sensors and batteries, gains in effective computing, and materials and manufacturing methods that result in comfortable and intuitive…

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Biden’s supply chain plans include made-in-America medicines

President Joe Biden [Image courtesy of the White House]

The Biden administration recently announced efforts to strengthen the pharmaceutical supply chain, mitigate shortages of essential medicines, and expand domestic manufacturing.

The new efforts are part of an overall package of initiatives to boost U.S. supply chains that the White Houe announced on Nov. 27. Securing the country’s supply of medicines and lowering prices have been an important priority for Biden since he took office nearly three years go. The goal is to increase access to essential medicines and medical products.

The latest round of actions include:

Invoking the Defense Production Act to broaden the Department of Health and Human Services’ (HHS) authorities to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that the president deems essential to the national def…
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ReValve reports successful first-in-human implant of next-gen TMVR

ReValve Solutions announced today that doctors successfully treated the first patient with its next-generation replacement heart valve.

Cardiologists at the Punta Pacifica Hospital, Panama City, Panama, performed the procedure. An 81-year-old male with a history of heart failure received the Palmetto transcatheter mitral valve replacement (TMVR). The patient also had a series of failed surgical bypass grafts and severe mitral regurgitation (MR) prior to the procedure.

ReValve completed the first implant of a previous iteration of the system back in 2021.

Dr. Charles Davidson of Northwestern Memorial Hospital and Dr. Temistocles Diaz of Punta Pacifica led the latest procedure. Dr. Douglas Boyd and Dr. Edris Aman assisted as well. They successfully completed the procedure in under an hour, reducing the patient’s MR to trace. At 30 days, the patient continues to present zero MR along with preserved ventricular function.

Davidson says the straig…

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Nordson Medical expands Pennsylvania operations

NEWS RELEASE: Nordson Medical expands Easton, Pennsylvania operations into an additional facility

Easton, Pennsylvania – November 29, 2023 – Nordson Medical, a global leader in the medical device components industry, is expanding its Easton, Pennsylvania operations into an additional facility less than two miles away. This expansion will allow an increased capacity of their fluorinated ethylene propylene (FEP) heat shrink tubing product line and potential additional manufacturing capabilities in the future.

Additional manufacturing capacity will allow Nordson Medical the ability to continue offering their innovative products, technologies, and solutions to their customers to assist them in bringing their complex medical devices to market.

“We are excited about how this expansion will benefit our customers and help increase our footprint of medical device components that are used to improve the lives of patients around the world,” said Todd Furman, director of o…

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