- Medical Design Sourcing

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…

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…

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…

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,…

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…

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…

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…

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…

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…

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…

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…

Nordson Medical unveils Pharma+ tubing retainers

Pharma+ tubing retainers [Image courtesy of Nordson Medical]

NEWS RELEASE: Nordson Medical unveils Pharma+ tubing retainers: a breakthrough in fluid transfer efficiency

Loveland, Colorado – November 29, 2023 – Nordson Medical, a Nordson company (Nasdaq: NDSN), is proud to announce the launch of Pharma+ tubing retainers, a revolutionary addition to their product portfolio that promises to redefine excellence in fluid transfer applications. These advanced tubing retainers have been meticulously engineered to address the critical challenges faced by professionals in the biopharmaceutical and high-pressure medical sectors, offering a comprehensive solution for leak-free fluid transfer.

The Pharma+ tubing retainers introduce a groundbreaking feature — a patent-pending lead-in ramp that creates complete 360° compression, ensuring a secure fit over hose barbs. This cutting-edge design eliminates potential leak poin…

Zilia earns FDA clearance for retinal camera

Co-founders Patrick Sauvageau and Dominic Sauvageau with the Ocular FC. [Image courtesy of Zilia]Zilia announced today that it received FDA 510(k) clearance for its Ocular FC retinal camera for non-invasive ocular assessments.

Quebec City, Canada-based Zilia designed the Ocular FC system for assessing ocular biomarkers. The company believes it could “transform the diagnosis and management of ocular diseases,” according to a news release. It said the FDA clearance marks a “pivotal moment” in the company’s growth.

The first-of-its-kind technology integrates advanced photonics and artificial intelligence (AI). This aims to leverage the eye’s optical properties and direct connections to the vascular system and the brain. According to Zilia, this could help to capture critical information both on ocular and overall health.

This technology harnesses imaging, spectrometry, and artificial intelligence to detect and measure biomar…

BiVacor wins FDA IDE for first-in-human artificial heart study

The BiVacor Total Artificial Heart (TAH) [Image courtesy of BiVacor]BiVacor announced today that the FDA granted investigational device exemption (IDE) for its total artificial heart (BTAH).

IDE approval allows BiVacor to begin its first-in-human early feasibility study (EFS) for the BTAH system. The Houston-based company aims to evaluate BTAH’s safety and feasibility as a bridge to a heart transplant for patients with biventricular heart failure.

BiVacor tapped 10 hospital locations for the study, for which it plans to initially enroll three patients. The company expects to begin the study in 2024 and to use its findings to lead into a subsequent pivotal study. This falls in line with the company’s timeline shared in March when it raised $18 million to support the BTAH’s development.

“I am eager to begin the BiVacor Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” said Dr. Josep…

FDA clears oral device for sleep apnea from Vivos Therapeutics

The mRNA oral appliance for treating obstructive sleep apnea. [Image courtesy of Vivos Therapeutics]Vivos Therapeutics (Nasdaq:VVOS) announced today that the FDA cleared its removable CARE oral devices for treating obstructive sleep apnea (OSA).

The CARE (complete airway repositioning and/or expansion) line includes the flagship DNA, mRNA and mmRNA oral appliances. Littleton, Colorado-based Vivos says its clearance makes it the first company bringing a clear alternative to CPAP or neurostimulation implants to market to treat OSA.

The state of the sleep apnea treatment space remains up in the air amid the major device recall at Philips. A new wrinkle was added to the mix yesterday when the FDA warned of thermal issues with certain Philips CPAP devices.

ResMed took hold of the sleep respiratory market as Philips still works through the recall. However, the company had its own struggles, leading to layoffs and an overall operating model shift. Inspire Medical,…

Fast Five: Henry Schein has more cybersecurity disruptions, Orthofix has a new CEO

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 29, 2023.

Fast Five by MassDevice · Fast Five: Henry Schein has more cybersecurity disruptions, Orthofix has a new CEO

Scottish startup 1nhaler raised $2.5 million as it looks to advance its sustainable single-use dry powder inhaler technology. Fast Five hosts Sean Whooley and Danielle Kirsh break down the plans for the company attempting to disrupt the drug delivery space.

The good news continues to come for ReWalk Robotics, which announced that it demonstrated proof-of-concept for its next-generation, AI-powered exoskeleton technology. The hosts look into the importance of this milestone, which follows a major reimbursement win.

GE HealthCare received FDA clearance for a new critical care algorithm that helps detect, notify and triage the diagnosis of pne…

FDA warns of thermal issues with Philips DreamStation 2 CPAP machines

The Philips DreamStation 2 continuous positive airway pressure (CPAP) device [Photo courtesy of Philips]The FDA is warning patients and health care providers to watch Philips (NYSE: PHG) + DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.

The medical device safety agency said it recently received an influx of medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while patients were using the devices.

It’s the latest safety warning for Philips respiratory devices, of which more than 5 million have been recalled for dangerous degradation of sound abatement foam. At least 385 deaths have been reported in connection with the foam-related recall.

“Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines,” the FDA said.…

First patient enrolled in Penumbra study of computer-assisted vacuum thrombectomy

The Lightning Flash system. [Image courtesy of Penumbra]Penumbra (NYSE:PEN) today announced the first patient enrolled in STORM-PE, a trial of its Lightning Flash thrombectomy system.

Lightning Flash, a mechanical thrombectomy system, received FDA clearance in January. The system features Penumbra’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove large blood clots, including venous thrombus and pulmonary emboli (PE).

This combination can differentiate between clot and blood. Its design, which helps reduce blood loss and the need for clot-dissolving drugs, may lower the risk of bleeding complications.

The trial evaluates anticoagulation alone against anticoagulation plus Lightning Flash for the treatment of PE. STORM-PE, a first-of-its-kind, multi-center, randomized controlled trial, aims to advance the understan…

NVIDIA and AWS collaborate to bring BioNeMo AI platform to the cloud

3D protein structure prediction with AlphaFold2, OpenFold, and ESMFold in NVIDIA’s BioNeMo. [NVIDIA]

Chipmaker NVIDIA and cloud behemoth AWS have been partnering for years, and now the two companies are announcing that NVIDIA’s drug discovery generative AI platform, BioNeMo, is now available on AWS. Additionally, plans are underway for BioNeMo to be offered on AWS on NVIDIA DGX Cloud.

The alliance was announced at the AWS re:Invent event. Startups including Evozyne, Etcembly and Alchemab are early AWS users using BioNeMo for generative AI-accelerated drug discovery and development.

Evozyne focuses on creating novel proteins for therapeutic development, Etcembly is building a large machine learning database for immunology and TCR immunotherapies, and Alchemab specializes in identifying protective antibodies for hard-to-treat diseases.

Last week, NVIDIA announced a collaboration with Genentech with BioNeMo also playing a ke…

FDA clears on-device triage algorithms for critical care from GE HealthCare

The Critical Care Suite 2.1 showing PTX overlay and confidence level. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + announced today that the FDA granted 510(k) clearance to its Critical Care Suite 2.1 with a pneumothorax (PTX) algorithm.

The industry-first clearance allows the suite to detect, notify and triage the diagnosis of PTX. Chicago-based GE HealthCare’s updated algorithm expands the suite’s on-device triage capabilities, according to a news release. It provides immediate notification of the presence or absence of PTX, plus an overlay display both on-device and in PACS.

GE HealthCare said its latest update displays an overlay in the area where the suite locates a PTX when detected. It assists with PTX localization and improves the speed and accuracy of PTX diagnosis. By hosting the Critical Care Suite on-device, GE HealthCare makes critical insights available at the point of care acro…

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