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MedTech News
Data backs splanchnic ablation procedure from Axon Therapies
The Satera ablation cathether. [Image courtesy of Axon Therapies]Axon Therapies today announced positive six-month results from a trial for its proprietary splanchnic ablation for volume management (SAVM) therapy.
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Dr. Marat Fudim, advanced heart failure specialist at Duke University Medical Center, presented results at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. The data came from a roll-in cohort for the REBALANCE-HF investigational device exemption feasibility trial.
Santa Clara, California-based Axon Therapies said its data remains consistent with prior results for the SAVM therapy. The novel, frontline therapy uses an outpatient ablation procedure. It aims to rebalance volume distribution for heart failure patients with preserved ejection fraction (HFpEF).
In addition to the positive results, Axon Therapies said it expects its trial to reach full enrollment by the end of the month. The approximately 120-patient study should…
Medtronic reveals more details on surgical business consolidation
Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today confirmed its consolidation of its Surgical Robotics and Surgical Innovations operating units into a single Surgical operating unit and said it would not close its facilities in Colorado and Connecticut.
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MassDevice was first to report the operating unit consolidation and promotion of former Surgical Robotics President Mike Marinaro to lead the new group.
Medtronic said the consolidation took effect Feb. 1.
“By combining these businesses, Medtronic will capitalize on one of the most attractive markets in all of healthcare — a market that is forecasted to nearly double over the next 10 years,” Medtronic said in a statement to MassDevice. “Our offices and campuses around the globe foster collaboration, build connectivity and community, drive innovation, and enable us to engage with customers. Surgical robotics operations in Colorado and Conn…
Medtronic turns to third-party developers to boost GI Genius’ AI
The GI Genius module’s AI-based enhancements include green boxes that highlight areas that may need extra scrutiny during a colonoscopy. [Image courtesy of Medtronic]
Medtronic has turned to Nvidia to enable an AI Access platform to boost the GI Genius intelligent endoscopy module’s capabilities.Think of a software-based business model — an app marketplace — where third-party developers create new AI tools to boost early colorectal cancer detection during colonoscopies. It’s a type of product development strategy that may become more common among medical device companies, especially as they shift toward more innovation in the digital space.
The world’s largest medtech company points to GI Genius as the first FDA-cleared, AI-assisted colonoscopy tool that helps physicians detect polyps leading to colorectal cancer. Cosmo Pharmaceuticals, GI Genius’s developer and manufactur…
Could this 3D printing method create bone-like ortho implants?
Researchers published a method for 3D-printing an ink that contains calcium carbonate-producing bacteria. The 3D-printed mineralized bio-composite is unprecedently strong, light, and environmentally friendly, with a range of applications from art to biomedicine. [Image courtesy of EPFL]
Researchers in Switzerland developed an ink that could potentially 3D print virtually any shape and gradually mineralize in a few days.The researchers operate in the Soft Materials Laboratory in the School of Engineering at EPFL Lausanne. It’s also known as the Swiss Federal Institute of Technology Lausanne.
Their 3D printable ink contains Sporosarcina pasteurii:. This bacterium, when exposed to a urea-containing solution, triggers a mineralization process that produces calcium carbonate (CaCO3). The researchers say they can use their “BactoInk” to 3D print a shape that gradually mineralizes over a hand…
Know Labs establishes scientific advisory board to advance non-invasive glucose monitoring
[Image from Know Labs]Know Labs (NYSE:KNW) announced today that it established a scientific advisory board to accelerate development for its glucose monitoring devices.
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Seattle-based Know Labs expects the members to advise on algorithm refinement, device development, clinical trial design and research publication strategy. They’ll work alongside the company’s current medical and regulatory advisory board members.
The company develops its proprietary Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. This technology integrates into wearable, mobile or bench-top form factors. Know Labs developed the first application of Bio-RFID as a non-invasive glucose monitor.
Get the full story at our sister site, Drug Delivery Business News.
Boston Scientific cuts back former Preventice workforce in Houston
Boston Scientific (NYSE:BSX) is reducing operations at a Houston facility it acquired as part of its $1.225 billion purchase of Preventice Solutions.
A layoff notice filed with the Texas state government in February says 120 jobs are affected, with the reductions starting on April 23 and continuing through June 25.
In a statement shared with MassDevice, the company said it is moving some of the work performed in Houston to its facility in Arden Hills, Minnesota. The transferred operations support the company’s mobile cardiac health tech.
The statement continued:
“This change will help us meet anticipated market demand for the products. Transferring work among our facilities helps us align our products, capabilities, technologies and resources to support our business strategies, and deliver value to our customers as well as life-changing medical solutions to patients. We initially informed employees of the intent to transfer this work i…
Vaccine patch maker Vaxess names former Sanofi exec as chief strategy officer
[Image from Vaxess]Vaxess Technologies, developer of a shelf-stable vaccine patch, announced today that it named Steve Bende as its new chief strategy officer.
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Bende previously served as global head of new products at Sanofi Pasteur. He led international, multifunctional teams at the pharmaceutical giant. That included assessing the commercial viability of potential new products.
Prior to Sanofi, Bende held the role of senior policy advisor for the HHS National Vaccine Program Office. Before that, his roles included president and CEO of Bacilligen, consultant for Science & Policy Strategies and The Livingston Group. He also served as VP of scientific affairs for Generic Pharmaceutical Association and as a researcher and administrator at NIAID.
Get the full story at our sister site, Drug Delivery Business News.
Cognito Therapeutics raises $73M Series B for non-invasive neuromod tech
This non-invasive neuromodulation device could become a new therapy for Alzheimer’s disease. [Image courtesy of Cognito Therapeutics]Cognito Therapeutics announced today that it raised $73 million in a Series B financing round to support its neuromodulation technology.
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Cambridge, Massachusetts-based Cognito Therapeutics develops its neurotechnology to treat central nervous system (CNS) diseases. It designed its non-invasive neuromodulation device to deliver proprietary gamma frequency light and sound stimulation. The investigational device is intended to treat Alzheimer’s Disease.
FoundersX Ventures led the funding round with participation from all existing investors. New investors Alzheimer’s Drug Discovery Foundation (ADDF), Starbloom Capital, IAG Capital and WS Investment Company (Wilson Sonsini’s venture arm) joined the round. Cognito Therapeutics said the Series B brings its total funds raised since inception to $93 million.
In addition to the fi…
First UK hospital to use Versius surgical robot from CMR Surgical
[Image courtesy of CMR Surgical]CMR Surgical announced that Royal Papworth Hospital NHS Foundation Trust, a leading UK hospital, introduced its Versius surgical robotic system.
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Cambridge, UK-based CMR Surgical called Royal Papworth “one of the world’s leading cardiothoracic hospitals.” It also serves as the UK’s main heart and lung transplant center. It’s now set to become the first hospital in the UK to use Versius for thoracic procedures.
CMR Surgical designed Versius to enable surgeons to perform more minimal access surgery. The company says this offers patients “access to the highest quality of surgical care.” Its minimally invasive approach assists surgeons accessing the lungs, thymus and esophagus.
Through small incisions in patients’ ribs, thoracic surgeons can work precisely and accurately in the chest cavity with Versius. It features small, fully wristed instruments and 3D vision. The surgical robot’s smal…
AccuCinch ventricular restoration system from Ancora Heart improves heart failure outcomes
The AccuCinch system. [Image courtesy of Ancora Heart]Ancora Heart announced today that its AccuCinch system demonstrated improvement in heart failure patient outcomes in an analysis.
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Patients treated with the investigational device also saw beneficial changes in the structure of the heart. Twelve-month data were presented at the Technology and Heart Failure Therapeutics conference (THT 2023) and simultaneously published in the Journal of Cardiac Failure.
Dr. Nadira Hamid, an interventional echocardiographic and cardiologist at Allina Health Minneapolis Heart Institute and assistant director of the echocardiographic core lab at CRF, presented the data at the conference in Boston. Hamid also co-authored the corresponding manuscript, “Transcatheter Left Ventricular Restoration in Patients with Heart Failure.”
Data included complete 12-month clinical outcomes from an analysis of 51 symptomatic heart failure patients. These patients, treated with AccuCinch, had…
Nvidia launches BioNeMo Cloud as a breakthrough AI service for drug discovery research
[Image courtesy of Nvidia]
During Nvidia’s (Nasdaq:NVDA) GTC event, the company introduced BioNeMo Cloud, a new component to their AI Foundations suite. This service, designed to streamline life sciences research, drug discovery and protein engineering, provides researchers with access to pretrained AI models, allowing for customization with proprietary data. Offered as a cloud service, BioNeMo Cloud enables accelerated drug discovery workflows, with multinational biotech company Amgen (Nasdaq:AMGN) and several startups already utilizing the platform.BioNeMo Cloud features pretrained AI models for molecular biology, chemistry and molecular dynamics. The platform allows researchers to fine-tune models with proprietary data, executing AI model inference via web browsers or new cloud APIs. This accelerates drug discovery, molecular identification and protein 3D structure prediction.
Featured models in…
David Schnur Associates partners with ERI Group
NEWS RELEASE: David Schnur Associates Welcomes ERI Group to its Global Network of Partners
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In-house electromechanical and fluidic ‘box build’ expertise complements DSA’s offering for medical device and life science customers
David Schnur Associates (DSA), a global supplier of outsourced technical sales and marketing services, recently announced an exclusive, multi-year strategic agreement to add ERI Group (formerly Evergreen Research) to its network of partner companies.
Based in Golden, Colorado, ERI Group provides services that span the entire process of bringing a medical innovation to market. The agreement with DSA focuses on “box builds,” bringing electromechanical and fluidic medical devices to market. Examples of ERI Group projects include home dialysis equipment, a battery-operated ultrasonic nebulizer and a computerized perfusion controller.
“ERI Group is an undiscovered gem that’s a perfect fit for our medical device and life science customers…
Study says heart failure survival improves with Abbott CardioMEMS monitoring tech
Implanted in a catheter-based procedure, the CardioMEMS HF system remotely monitors pulmonary artery (PA) pressure changes to provide an early warning of worsening heart failure. [Image courtesy of Abbott]Abbott (NYSE:ABT) today announced new data supporting hemodynamic pressure sensing with its CardioMEMS HF system.
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The data comes from an analysis evaluating CardioMEMS HF in heart failure patients with reduced ejection fraction (HFrEF). It aims to give doctors specific insight into how remote monitoring can provide early warnings for worsening heart failure. Abbott said it could demonstrate significantly reduced mortality risk (by 25%) at two years for HFrEF patients.
Abbott presented the meta-analysis of three randomized, controlled trials at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. Data came from the Champion, Guide-HF and Laptop-HF trials. Abbott said it reinforces that remote monitoring technology, like CardioMEMS, can help do…
Aortix circulatory support device from Procyrion produces positive study results
The Aortix pump therapy device. [Image courtesy of Procyrion]Procyrion today announced study results demonstrating that use of its Aortix device led to rapid decongestion in a pilot study.
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Houston-based Procyrion evaluated Aortix percutaneous mechanical circulatory support (pMCS) pump in patients with acute decompensated heart failure (ADHF) and worsening renal function. This is known as cardiorenal syndrome (CRS).
The pump patients — unresponsive to available medical therapy — demonstrated significant improvements across a range of functions. These include kidney function, cardiac function and patient-reported assessment of shortness of breath at 30 days.
Procyrion presented results today at the Technology and Heart Failure Therapeutics (THT) conference in Boston.
Dr. Jennifer A. Cowger, section head of heart transplantation and mechanical circulatory support, Henry Ford Hospital in Detroit, said patients with CRS often end up the most difficult to …
Vick’s Nyquil FDA compliance issues explained
[Dextromethorphan is an active ingredient in NyQuil. Image from raimund14/Adobe Stock]
Procter & Gamble (NYSE:PG) recently received a warning letter from FDA for failing to meet the agency’s requirements in the drug listing. The warning related to Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (National Drug Code (NDC): 58933-541), a powdered medicine intended to be dissolved in hot water before use.The FDA’s drug listing process requires submitting information related to a drug product, including its name, active ingredients, dosage form, strength and labeling information. The agency asks that the information be submitted to its electronic Drug Registration and Listing System (eDRLS), an online application.
In its warning letter to Procter & Gamble, FDA noted that it sent a letter dated October 31, 2022 to the manufacturer with a list of deficiencies related to a type of Vicks Ny…
Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance
A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]
The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…
Endolumik’s illuminated device takes a big step for safety
The Endolumik Gastric Calibration Tube emits near-infrared light for enhanced visibility during bariatric procedures.
Endolumik’s story started a few years ago as the FDA sounded the alarm over the risks of internal surgical staplers.
In 2019, the federal agency warned healthcare providers that it had received more than 41,000 medical device reports (MDRs) related to surgical staplers and staples for internal use from 2011 to 2018. Those MDRs tallied more than 32,000 malfunctions, at least 9,000 serious injuries and 366 deaths.
Two years later, the FDA increased the risk level associated with the staplers, reclassifying the devices from Class I to Class II and subjecting them to premarket review and special controls.
Bariatric surgeon Dr. Nova Szoka had already been working on a device that could prevent some of those injuries. She envisioned an illuminated gastric calibration tube that …
Medtronic combines surgical robotics and surgical innovations units
Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]A senior Medtronic executive’s promotion is the latest piece of the puzzle as the world’s largest medical device company seeks significant expense reductions.
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Mike Marinaro, who became president of Medtronic’s Surgical Robotics operating unit one year ago, is now EVP and president of Medtronic’s Surgical operating unit.
Fridley, Minnesota-based Medtronic (NYSE:MDT) didn’t announce the changes in a press release or a regulatory filing.
Instead, the medtech manufacturer quietly updated its website to reflect Marinaro’s new title and the “newly created” operating unit, “bringing together a legacy of surgical devices and the new robotic-assisted surgery technology to redefine the future of surgery.”
It’s not clear exactly when Medtronic updated the website, which said Marinaro was “recently appointed” t…
Study backs CVRx Barostim neuromod for patients with heart failure
CVRx’s Barostim Neo [Image courtesy of CVRx]Data presented today supported the use of the Barostim neuromodulation device from CVRx (Nasdaq:CVRX) in patients with cardiovascular diseases.
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The BeAT-HF trial evaluated the Barostim extravascular, implantable neuromodulation device. Dr. Robert Zile, professor of cardiology at the Medical University of South Carolina, presented findings at the second annual Technology and Heart Failure (HF) Therapeutics (THT) conference in Boston.
Trial detailsZile said that the trial evaluated 323 randomized patients with a median follow-up of 3.6 years. The study of the FDA breakthrough device spanned 103 U.S. centers and five UK centers.
Findings included 97% freedom from major adverse neurological or cardiovascular (MANCE) system or procedure-related events. Long-term symptom improvement compared to control included a 44-meter improvement in a six-minute hall walk at 12 months. Quality of Life improved by 10 points on…
NuVasive expands indications of limb lengthening system to include pediatrics
NuVasive this week announced it received FDA 510(k) clearance for the use of its Precice all-internal limb lengthening solution for pediatric patients.
Precice is a magnetically adjustable technology that uses an external remote to non-invasively lengthen implants. The system’s nail has been implanted more than 15,000 times by more than 2,000 surgeons.
“Precice has over a decade’s worth of clinical data and has truly changed the standard of care for my patients,” said Dr. John Herzenberg, director of pediatric orthopedics at Sinai Hospital. “This new indication is significant for my practice as the majority of my patients are under the age of 18, and it provides me with the assurance I need to offer Precice as a pediatric LLD solution.”
The company plans to further its ability to treat the full continuum of care with intelligent surgery.
“Everyone faced with limb length discrepancy (LLD), especially pediat…