All MedTechStart Articles

Cell therapy is a promising, rapidly advancing field with the potential to transform treatment across disease areas with significant unmet needs.

Medical advances make pills to treat Alzheimer's disease viable, though challenges remain in sharing gains globally.

Women are still under-represented in medical research. Here's where the gender gap is most pronounced.

Artificial intelligence is accelerating drug discovery. If clinical development fails to keep pace, the benefits to patients will be delayed.

The EPA will review ethylene oxide emissions standards for medical device sterilizers. A potential two-year compliance exemption is under consideration.

Vivani Medical to spin off neurostimulation business as Cortigent, advancing brain implants for vision and movement recovery.

Vicarious Surgical appoints Sarah Romano as CFO, filling a key vacancy as it advances its single-port surgical robotics system.

The FDA warns of a hemodialysis bloodline shortage due to B. Braun’s supply disruption, urging providers to adopt conservation strategies and seek alternatives.

Philips recalls its Tack Endovascular System after 20 injuries, with the FDA issuing a Class I recall due to risks of arterial blockages and complications.

Boston Scientific leads a $175M investment in 4C Medical to fund a pivotal trial of its transcatheter mitral valve replacement device, supporting innovation in minimally invasive heart therapies.

The FTC is blocking GTCR’s $627M acquisition of Surmodics, citing antitrust concerns over hydrophilic coating market dominance. The agency argues the merger would stifle competition and innovation.

Dexcom received an FDA warning letter citing manufacturing issues at two facilities. While corrective actions are underway, the company does not expect a major impact on sales, manufacturing, or new product approvals.

Staar Surgical is laying off 115 employees in California due to weak demand in China, its largest market. The company cites economic and geopolitical challenges as factors behind the job cuts.

Quest Diagnostics is set to acquire kidney disease testing assets from Fresenius Medical Care, enhancing its dialysis-related services. The deal will optimize lab efficiency and streamline diagnostics for Fresenius dialysis centers across the U.S.

Thermo Fisher is acquiring Solventum’s purification and filtration business for $4.1 billion, strengthening its bioprocessing portfolio. The deal, expected to close by year-end, will enhance Thermo Fisher’s biologics development capabilities.

Medtronic’s BrainSense Adaptive DBS system, the first self-adjusting deep brain stimulation device for Parkinson’s, has received FDA approval. This brain-computer interface technology personalizes therapy in real time, enhancing symptom management and patient outcomes.

Navigating the FDA approval process? Learn the key differences between 510(k), PMA, and De Novo pathways to determine the best route for bringing your medical device to market efficiently and compliantly.

Boston Scientific has recalled Accolade pacemakers due to a malfunction that can trigger permanent safety mode, affecting 203,000 devices worldwide. Linked to 832 injuries and two deaths, the recall may require device replacements to ensure patient safety.

The FDA’s sudden firing of over 200 employees, including AI and digital health experts, is already delaying medical device approvals and raising concerns within the industry. Experts warn that the cuts could add months or years to regulatory timelines, prompting trade groups and legal advisors to explore ways to mitigate the impact.

Baxter is actively searching for a new CEO following a year of restructuring, divestitures, and operational recovery, positioning the company for renewed growth. With a stronger financial outlook and key manufacturing sites back online, leadership aims to drive innovation and stability in 2025.

VitalConnect raised $100 million to commercialize its AI-powered Vitalpatch, a real-time cardiac monitoring device that tracks arrhythmias and other vital signs. With strong investor backing and growing sales, the company is poised to expand its technology and compete with leading heart monitor brands like iRhythm and Bardy Diagnostics.

Siemens Healthineers is opening new logistics depots in California and New Jersey to expand inventory by 30% and improve same-day delivery capabilities. By enhancing its supply chain resilience and efficiency, the company aims to better serve healthcare providers while reducing logistical disruptions and environmental impact.

Vision-correcting surgeries have revolutionized the way people manage common vision problems like myopia (nearsightedness), hyperopia (farsightedness), and astigmatism.

A 510(k) is a marketing submission to the FDA made by a manufacturer to demonstrate that a new device is substantially equivalent to an existing "predicate device."

Edwards Lifesciences anticipates a boost in transcatheter aortic valve replacement (TAVR) sales in the second half of 2025, driven by an expected FDA approval for an expanded Sapien valve indication. Despite ongoing hospital capacity challenges, executives remain optimistic about long-term growth fueled by new technologies and increasing patient demand.

The European Medicines Agency (EMA) has introduced a portal allowing manufacturers of high-risk medical devices to seek expert scientific advice on clinical development and investigation strategies. This initiative, initially tested in a pilot program, aims to accelerate access to innovative medical technologies by providing structured guidance from expert panels.

Former FDA Commissioner Scott Gottlieb is advocating for reduced regulatory oversight of certain AI-driven clinical decision support tools, arguing that recent FDA policies have created uncertainty and hindered innovation. He calls for a return to an earlier interpretation of the 21st Century Cures Act, which exempted more AI tools from premarket review.

Medtronic has acquired Nanovis’ nano surface technology to enhance its PEEK interbody spine fusion implants, aiming to improve bone growth and implant fixation. The deal aligns with Medtronic’s broader strategy to expand its spine portfolio, leveraging advanced technology and market scale.

Medical devices, enhanced by AI and IoT, are transforming telemedicine by enabling remote diagnosis, monitoring, and treatment. These innovations improve patient outcomes, enhance efficiency, and make healthcare more accessible and cost-effective.

GE Healthcare is investing $138 million to expand its contrast media manufacturing facility in Cork, Ireland, increasing production capacity by 25 million patient doses per year by 2027. This move strengthens its supply chain, addressing the rising global demand for contrast-enhanced imaging and reinforcing its position in a $7 billion market.

The FDA has designated Olympus’ recall of the MAJ-891 forceps/irrigation plug as Class I, citing serious infection risks linked to improper reprocessing of the discontinued device. Affecting over 30,000 units, the recall highlights ongoing safety concerns with reusable endoscopes, pushing the industry further toward single-use alternatives.

The FDA's 510(k) review process consists of four main stages: acknowledgment, acceptance, substantive review, and decision-making, with key checkpoints for submission completeness and regulatory compliance. Applicants should respond promptly to any deficiencies, as delays can lead to withdrawal, while the FDA aims to issue a clearance decision within 90 days, barring hold periods.

Medtronic has recalled its Becker and Exacta external drainage systems due to potential cracks and leaks that could cause cerebrospinal fluid loss, infections, or death. While the devices remain on the market, the FDA has classified the recall as Class I, urging providers to inspect and return defective units to prevent serious patient harm.

Pulse Biosciences has appointed Jon Skinner as CFO amid ongoing leadership changes, positioning the company for the commercialization of its pulsed field ablation (PFA) technology. With multiple clinical trials on the horizon and strong investor interest, Pulse is aiming to challenge industry giants like Medtronic and Boston Scientific in the rapidly growing PFA market.

Stryker is selling its U.S. spinal implants business to Viscogliosi Brothers, forming VB Spine, and plans to divest other international spine assets. Meanwhile, the company is moving forward with its $4.9 billion acquisition of Inari Medical, strengthening its position in the growing vascular disease treatment 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.

Zimmer Biomet is acquiring Paragon 28 for $1.1 billion, strengthening its position in the fast-growing foot and ankle implant market. Analysts view the deal as a strategic move, with expectations that Zimmer may continue expanding through further acquisitions beyond orthopedics.

The FDA has issued a warning about cybersecurity vulnerabilities in Contec and Epsimed patient monitors, which could allow unauthorized users to manipulate the devices and access sensitive patient data. With no available software patch to mitigate the risk, healthcare providers are advised to disconnect the devices from the internet or cease their use entirely if remote monitoring is required.

Advancements in medical devices for pets, such as wearable monitors, prosthetics, and advanced imaging, are revolutionizing veterinary care by improving diagnostics, treatment, and overall quality of life. As technology continues to evolve, these innovations are helping pets live longer, healthier lives while giving owners greater peace of mind.

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.

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.