All MedTechStart Articles

Abbott is set to launch its first Pulsed Field Ablation (PFA) device outside of the U.S. in 2025, with hopes of gaining CE Mark approval in the first half of the year. The company also sees growth opportunities in its diabetes care business and plans to expand sales of its over-the-counter glucose sensors.

Medtronic's Inceptiv closed-loop spinal cord stimulation device has shown lasting improvements for patients, including reduced overstimulation and lower opioid use, leading to double-digit sales growth in the company's pain stimulation unit. The device, which adjusts stimulation levels based on body signals, is positioned to help Medtronic regain market share in the competitive pain stimulation sector.

Intuitive Surgical is acquiring businesses in Italy, Spain, Portugal, Malta, and San Marino to establish a direct presence and better address local customer needs. The acquisition comes as Intuitive prepares for the European launch of its da Vinci 5 robot amidst challenges in the region's healthcare capital market.

Beta Bionics aims to raise $114.4 million through an IPO to fund the development of its iLet insulin delivery system and bihormonal version that delivers both insulin and glucagon. With a growing patient base and plans to introduce a patch pump by 2027, the company is positioning itself to expand its presence in the Type 1 diabetes market, especially by converting patients from insulin injections to automated insulin pumps.

In the medical device industry, ensuring product safety, effectiveness, and compliance with regulatory standards is paramount. A robust Quality Management System (QMS) serves as the cornerstone for achieving these goals, while also facilitating consistent quality and compliance and fostering trust among stakeholders, including patients, healthcare providers, and regulatory authorities.

When bringing a new medical device to market in the United States, one of the first—and most critical—steps is determining its classification. This step is crucial because it dictates the regulatory pathway for FDA approval, as well as the level of regulatory oversight your device will require.

Illumina is partnering with Nvidia to integrate AI into multiomic data analysis, enhancing genome research and drug discovery by combining sequencing technology with advanced computing power. The collaboration will provide researchers and pharmaceutical companies with more efficient tools to analyze complex biological data and improve therapeutic development.

BD is expanding its syringe, needle, and IV catheter production capacity in Nebraska and Connecticut, creating over 215 jobs after a $10 million investment. Despite recent layoffs, the company continues to focus on growth, with plans to invest an additional $30 million in 2025 to increase IV catheter production in Utah.

Hologic has stopped manufacturing and distributing its Biozorb implantable radiographic markers after an FDA warning letter highlighted design flaws and unresolved safety concerns. Although the product is no longer on the market, the FDA remains concerned about adverse events in patients already implanted with the device and is urging Hologic to take further action.

Philips has recalled its heart monitor software after a data routing failure resulted in 109 injuries and two deaths by preventing healthcare professionals from reviewing critical ECG events over a two-year period. The FDA classified the recall as a Class I event, urging healthcare providers to reprocess affected patient data and inform patients of potential risks.

Boston Scientific will acquire the remaining 74% of Bolt Medical, developer of an intravascular lithotripsy (IVL) platform for coronary and peripheral artery disease, for up to $664 million.

Johnson & Johnson has temporarily halted the U.S. rollout of its Varipulse pulsed field ablation (PFA) system to investigate neurovascular events reported in four cases during an external evaluation.

Medtronic has entered a five-year exclusive sales agreement with Kuros Biosciences to distribute the MagnetOs bone graft technology for spine procedures in specific U.S. regions.

Fire1 has secured $120 million in funding, with support from investors like Medtronic and Novo Holdings, to advance its Norm heart failure management system through pivotal clinical trials.

The HHS has proposed its first HIPAA security rule update since 2013 to combat increasing cyberattacks in the healthcare sector by introducing detailed requirements for risk analysis, technology inventories, multi-factor authentication, and vulnerability testing.

An FDA-commissioned review found no evidence of safety concerns linked to tampons, despite a recent study suggesting potential metal exposure, though further research is recommended to address evidence limitations.

The FDA has issued an early alert regarding Medline's fluid delivery sets with incorrect drip chambers, warning of potential safety risks including fluid over-administration, as part of a pilot program to enhance recall communication timeliness.

A collaboration between Children’s National Hospital and the FDA aims to address the challenges of developing pediatric medical devices using advanced regulatory science tools and in silico trials to improve safety, efficacy, and market accessibility.

In 2024, medical device recalls, including high-profile cases like Philips’ respiratory devices and Abbott’s Heartmate pumps, prompted increased scrutiny and regulatory action aimed at improving recall transparency and patient safety.

In 2024, the medtech industry engaged in key discussions about new technologies like AI, robotics, and pulsed field ablation, alongside the challenges of competition, cybersecurity, and regulatory oversight.

The medtech industry saw significant layoffs throughout 2024, with companies like Masimo, Smith & Nephew, Boston Scientific, and Edwards Lifesciences announcing job cuts as part of cost-saving measures, facility closures, and restructuring initiatives.

Medtech companies like Johnson & Johnson and Boston Scientific led 2024's M&A activity with large acquisitions, while the industry saw a broader trend of smaller, targeted deals focused on growth areas like AI, cancer treatment, and surgical technologies.

Boston Scientific has revised the instructions for its Polarx and Polarx FIT cryoablation balloon catheters following an unexpected number of esophageal injury reports during atrial fibrillation treatments, the FDA announced.

Anteris Technologies, a heart valve developer, debuted on the U.S. stock market under the Nasdaq ticker symbol “AVR,” raising approximately $88.8 million at $6 per share.

Onward Medical's FDA-approved ARC-EX system delivers groundbreaking, non-invasive spinal cord stimulation, offering a new lease on life for spinal cord injury patients. Backed by clinical success and a robust development pipeline, the company is poised to transform neuromodulation therapies worldwide.

Sotelix Endoscopy has raised $1.7 million to develop incision-free therapeutic tools that transform gastrointestinal care. Backed by a stellar team and growing market momentum, the startup aims to lead the future of minimally invasive endoscopic innovations.

Patterson Companies’ $4.1B sale to Patient Square Capital marks a strategic shift as the dental and veterinary supplier addresses financial struggles and declining profits. Backed by a 49% stock premium, this acquisition paves the way for a fresh start under the stewardship of a seasoned healthcare investor.

The FDA's new early alert system sprang into action with a recall of Fresenius Kabi’s Ivenix infusion pumps, spotlighting faulty valves that could disrupt life-saving treatments. With over 1,500 devices impacted, healthcare providers are racing to prevent dangerous interruptions in patient care.

Capstan Medical is transforming heart valve treatment with a groundbreaking robotic-assisted platform, tackling mitral and tricuspid valve diseases with precision and innovation. Backed by $110M in new funding, Capstan is ready to challenge industry giants and redefine cardiac care.

Endoquest Robotics is revolutionizing colorectal surgery with a groundbreaking robotic system designed for minimally invasive procedures via natural orifices. Backed by FDA approval for clinical trials, this technology could transform patient care with fewer scars, faster recoveries, and less invasive alternatives to major surgeries.

Gerardo Hernandez steps in as Transmedics’ new CFO to spearhead growth as the company faces intensifying competition. The appointment comes with a revised financial outlook for 2024, signaling the challenges ahead.

GE Healthcare is taking full control of Nihon Medi-Physics, a Tokyo-based firm specializing in life-saving radiopharmaceuticals, solidifying its strategy for growth in precision care.

Edwards Lifesciences is preparing for a major sales boost with the 2025 approval of its TAVR system for asymptomatic patients, which promises to redefine treatment guidelines for aortic stenosis.

Insulet has secured a major legal victory with a $452 million verdict against EOFlow, underscoring the critical importance of protecting intellectual property in the medtech industry.

Boston Scientific announced its intention to acquire Intera Oncology, the developer of the Intera 3000 hepatic artery infusion (HAI) pump and the chemotherapy drug floxuridine.

Medtronic has announced a three-year contract with the Department of Veterans Affairs (VA) to install nearly 100 additional GI Genius endoscopy units, building on a 2022 agreement that initially covered 115 units.

Johnson & Johnson has named Shawn Millerick as the president of its vision care unit for North and Latin America, where he will define strategy and drive growth for products like Acuvue contact lenses.

Zimmer Biomet announced FDA approval for its Oxford Cementless Partial Knee implant, a device that has been established in Europe since its 2004 launch, where it holds a 60% market share.

Align Technology has achieved a CE mark under MDR for its groundbreaking Invisalign palatal expander system, the first direct 3D-printed orthodontic device in its portfolio.

Medtronic has acquired Fortimedix Surgical, a Dutch innovator known for developing highly responsive, flexible instruments enabling minimally invasive and endoscopic procedures.

The FDA's Center for Devices and Radiological Health (CDRH) has introduced a pilot program to notify the public more quickly about potentially high-risk medical device recalls.

GE HealthCare has unveiled new clinical applications for its OEC 3D mobile CBCT C-arm portfolio, enhancing imaging precision for complex pulmonary and thoracic procedures.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

Explore 510k Consulting for FDA Clearance: Your Guide to Medical Device Submission Discover the intricacies of 510k consulting for FDA clearance. Learn about medical device classifications, submission steps, and the Refuse to Accept (RTA) process. Ensure your device's substantial equivalence with expert insights.

Discussing the impact of CTEs and post-traumatic amnesia is NFL players. What causes it, is it clinically proven, and how it can best be detected and treated.

When it comes to recruitment, you want to hire the best professionals, fast. Choosing the right hiring platform is crucial to sourcing talent, but each platform has its own set of advantages and disadvantages. As an employer seeking to optimize hiring processes, it is essential to weigh the pros and cons of popular platforms like Indeed, LinkedIn, and ZipRecruiter.

It's crucial to operate your quality system as if the FDA could audit you at any given moment: focus on what you need, and not just bigger quality systems.

The staff of Prime Path Medtech discuss their picks for best travel suitcases - tested and approved by medical device consultants who do their share of travel.

According to a publication in the journal Technology in Society, the COVID-19 pandemic has led to remote work commonplace, like traditional in-person work.

The emergence of digital health technologies has marked a transformative era in the medical and healthcare industries. These tools, systems, and devices promise to make patient care more personalized, accessible, and efficient.
This fast-growing sector represents a lucrative frontier for entrepreneurs interested in leveraging technology to solve complex health challenges.

Corporate social responsibility (CSR) can take many different forms, depending on the mission of the company and the type of impact it wishes to have on the world.

With fractional staffing, medical device companies
can tap into a pool of professionals
who possess expertise in areas such as regulatory
affairs and clinical trials

The FDA's medical device design controls are a set of regulations and guidelines aimed at ensuring the safety and effectiveness of medical devices. These controls are outlined in the Quality System Regulation, which is part of the Code of Federal Regulations (CFR) Title 21.

While SSRIs and therapy have long been considered the first line of defense against anxiety, there is much to be said for a gentler, more physical approach.

What does it mean if you are someone with a messy desk? Does it speak to your own personality, or does it mostly signal to others what you might be like to them?

Synergia Medical’s innovative epilepsy treatment device, NAO.VNS, has been successfully implanted in its first human trial.

A well-crafted brand story can do more than just inform; it can inspire,and ultimately drive loyalty. How can storytelling can transform your brand-building journey?

About how dental clinics can manage the fear of their patients, addressing increasing anxiety disorders using soft and hard methods, and determing the root causes.

When in an office, on-site, or travelling, self-care is often easily overlooked and nutrition waylaid in favor of quick fixes and snacks - how can we fix this?

Core product/service offering and your company name, your product name(s), logos, and maybe even a slogan/tagline are intellectual property, and can be protected.

At first glance, mindfulness and work seem like they wouldn’t go together. Mindfulness is the idea of enjoying and focusing on the very moment in which we are.

These substances, such as LSD (lysergic acid diethylamide) and psilocybin (found in certain mushrooms), are being creatively studied for medical effectiveness.

Medical procedures and knowledge have gone through many levels of understanding and implementation for civilization to arrive at its modern medical practices.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

You may have heard of Jack Eichel Surgery? In the National Hockey League (NHL), the choice for Cervical Intervention has always been Cervical Spinal Fusion.

Discusses nine simple ways to cut business expeneses, focusing on the small to medium business segments and the medical device industry, from experts in the field.

Intellectual Property (IP) is arguably one of the most important assets a company owns. Having a strategy in place for protecting and preserving your IP is vital.

AI Chat has exploded, leaving many people confused about what they are and how to use them. Here, we walk through some of their best uses and some potential pitfalls

Since 2012, Utah has become home to over 1,000 life science companies add $13 Billion to the state’s GDP, while providing employment for over 50,000 employees.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

This article will take you thru multi-channel marketing, where to start, and how to grow your marketing skillset consistently, along with your business outreach.

Discusses the health benefits and impact of listening to music while running. Its impact on the brain, mood, and performance, as well as habit-forming power.

Discusses the medical applications of laser technological advancements in the last decade, from famous and elective examples to life-saving advancements in care.

Discusses Viedoc, its recent headwinds, and why it may be the right fit for your business or practice. Cites recent studies and interviews for justification.

Let’s face it, artificial intelligence (AI) is everywhere these days. Every company is fixated on AI's “greatest tool of all time” to save money, effort, and time.

The unique challenges of this sector in MedTech, including strict regulatory requirements and specialized product demands make SCM a vital component of success.

Prime Path MedTech discusses how to effectively promote diversity in clinical trials, ensuring medical devices and medicines are effectively tested without bias.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

Since early 2020, working from home, also known as remote work, has been on the rise. Is it healthier, from a medical perspective? Is it as efficient as office work?

The pancreas is a tadpole shaped organ that resides in the upper abdomen behind the stomach, but in front of the spine. It secretes insulin, a critical hormone that helps regulate blood sugar. But what happens when it isn’t functioning correctly, or the insulin it secretes isn’t being accepted by the body?

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

GE HealthCare’s new FDA-approved brain imaging tool promises to revolutionize Alzheimer’s diagnosis by providing clinicians with a more accurate method to measure amyloid plaque density, just as new treatments enter the market.

MDSAP, or the Medical Device Single Audit Program, stands as an acronym that resonates across the medical device industry: a pioneering international endeavor.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

As a small business owner, it can be difficult to judge how much paid time off is appropriate for both you and your employees. So, what does the science say?

Chronic procrastination can be a bigger problem, however. Some of the signs that you might be a chronic procrastinator are... I'll get to it later. Maybe tomorrow.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

A study published in the Journal of Occupational and Environmental Medicine in 2018 found that business travelers who spent more than 14 nights per month away from home had higher body mass indexes and reported more health problems such as depression, anxiety, alcohol abuse, difficulty sleeping, lack of physical exercise, and smoking than those who traveled less. Is there any way to stay healthy and productive while on the road for work? Here are some strategies to help you beat the odds.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

A Comprehensive Guide to Achieving Medical Device Approval in the EU. Compares to US regulations from the FDA, and how the MDR judges and categorizes medical devices

A new amendment to EU 2017/745 (EU MDR) has been published in the Official Journal of the European Union. The release of Regulation 2023/607 on March 15, 2023.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

If you’re like me, your secret indulgence late at night, after everything has settled down and you’ve gathered a few snacks from the kitchen, maybe a blanket to hide behind for when you’re scared, is a good crime documentary.

Maybe you like the challenge of guessing who the killer is, or feel like you could have been a detective in another life. Or maybe you just like things that are scary and go bump in the night.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.

This article will guide startup companies through essential aspects of using LinkedIn to improve their brand image. LinkedIn is a goldmine for brand presence.

Aditxt and Evofem are set to revolutionize endometriosis diagnosis with a first-of-its-kind blood test, aiming for a 2025 US launch. This non-invasive test could transform care for millions affected by this underdiagnosed condition.