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Medtech Articles
50 articles found
Medtech Magazine: MDR Certification Success Hinges on Efficient Processing
RISE MNB's article highlights strategies for manufacturers to expedite MDR certification, achieving it in 6-9 months compared to the 12-18 month average. They attribute faster certification to proactive strategies like integrating regulatory compliance early in product development and actively engaging in open communication with notified bodies throughout the process.
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Careium Appoints Tove Christiansson as CEO; Walén Departs
Tove Christiansson, the current Chair of Swedish Medtech, will become Careium's CEO in Q2 2026, succeeding the interim CEO in place since August. Christiansson brings experience from Medcap, including her role as Head of Aids and CEO of Abilia, and is recognized by Careium's Chairman as a commercially-driven leader with expertise in the welfare technology sector and M&A-driven growth.
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PR Insights for Nordic Scaleups
Survey of PR challenges among 314 Nordic startup and scaleup companies.
Read the report
Medtech firms face EU digital regulation challenges, warns Medtech Magazine
Pernilla Norman writes in Medtech Magazine that the EU's "digital decade" legislation, including the "omnibus package" intended to simplify administrative processes, could paradoxically increase complexity for medtech companies through revisions to the GDPR and the AI Act. Multiple acts like the Digital Markets Act, Digital Services Act, NIS2 Directive, Data Act, and Cyber Resilience Act may create an increasingly complex regulatory environment, which could undermine the EU's simplification goal.
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Addlife Expands Labtech Division with Acquisition of Two Danish Companies
Addlife, through its Labtech business, acquired Danish companies Pharmacold A/S and Opitek International ApS, according to Medtech Magazine. Pharmacold, specializing in temperature-controlled storage, will be integrated into Addlife's Holm & Halby subsidiary to broaden their product portfolio and offerings. Addlife, a company known for strategic acquisitions, has further expanded its Labtech business area with the acquisition of Danish companies Pharmacold A/S and Opitek International ApS, according to Medtech Magazine. The acquisition of Pharmacold A/S, a specialist in temperature-controlled storage solutions for the pharmaceutical and healthcare industries, represents a key strategic.
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Magloy Tech: Singapore Medtech Startup Founded by Manakari and Parande
Magloy Tech, a Singaporean medtech startup founded by Manakari, Parande, and Professor Gupta, created OrthoMag, a biocompatible magnesium alloy bone implant. Designed to dissolve over time, OrthoMag eliminates the need for a second surgery to remove it, leading to reduced patient risk, with Magloy Tech also receiving funding from firms such as Origgin Ventures and Startup SG Tech.
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Medtech industry faces challenges due to new tariffs, currency effects
TL;DR: Getinge CEO Mattias Perjos stated in Medtech Magazine that Liberation Day's new tariffs and currency fluctuations are challenging the medtech industry, potentially threatening patient access to crucial healthcare solutions. Simultaneously, artificial intelligence and digitalization are rapidly transforming operational practices in both healthcare and medtech.
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Medtech Magazine: Proposed Law Changes to Increase Accessibility Requirements
Sweden proposes amending the Freedom of the Press Act and the Fundamental Law on Freedom of Expression to comply with the EU's accessibility directive. This will broaden accessibility requirements for products and services protected under media constitutional laws, including e-books and e-commerce, with an effective date of January 1, 2027.
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Medtech Magazine:
Swedish healthcare faces persistent inefficiencies, as reported by Catharina Barkman in Medtech Magazine. Reviews confirm issues with managing medical referrals, leading to misplacement, delays, redundant testing, and increased costs. Barkman highlights the lack of tracking for referrals, akin to package delivery, revealing communication breakdowns that impede timely patient care.
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Surgical Science Stock Plummets After Intuitive Terminates Da Vinci Agreement
Surgical Science's stock plummeted by over 60% after Intuitive Surgical ended an agreement to integrate their simulation software into all new Da Vinci 5 robots. Intuitive Surgical now intends to offer Surgical Science's software to select clients only and include their own simulation package in the remaining Da Vinci 5 systems, impacting the market's perception of Surgical Science.
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Elekta to cut 450 global positions during company reorganization
Elekta, a medical tech firm, will cut around 450 jobs globally, as revealed in their report on Wednesday, November 26, 2025. This restructuring follows underperformance despite market advantages and a relevant product line, impacting management positions. According to a report in Medtech Magazine, Elekta, a medical technology company, is implementing a restructuring plan that will eliminate approximately 450 positions worldwide. The announcement, included in the company's quarterly report released on Wednesday, November 26, 2025, cited underperformance relative to its potential despite operating within a favorable market and possessing a pertinent.
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Intellego CEO Detained for Fraud; Nasdaq Delisting Sought, Reports Medtech Magazine
Claes Lindahl, Intellego Technologies' ex-CEO, has been detained due to heightened suspicion of aggravated fraud, according to a Stockholm District Court ruling. The investigation, led by State Prosecutor Thomas Hertz, is scrutinizing Intellego's public communications since 2025 to ascertain if investors were intentionally misled regarding the company's market value. Nasdaq is also in the process of delisting Intellego Technologies from the First North exchange.
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Paradromics' Brain Implant Receives FDA Approval for Speech Restoration Trials
Paradromics received FDA approval for clinical trials of their Connexus brain chip, designed to restore speech for individuals with severe communication disabilities. The Investigational Device Exemption allows Paradromics to begin early-stage human trials of their brain-computer interface, positioning them as a competitor with Neuralink and Synchron in the neurotechnology industry.
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Veronica Arthurson Appointed Health Director for Region Norrbotten in Sweden
Veronica Arthurson, currently a Director at the Swedish Medical Products Agency, has been appointed Health and Medical Care Director for Region Norrbotten, Sweden, no later than May 2026. Region Director Ulrika Sundquist cited Arthurson’s background in pharmaceutical matters and emergency preparedness as key reasons for her selection, with Arthurson noting the unique challenges of providing healthcare in the region.
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Philips and Edwards Lifesciences Develop AI Tool for Heart Valve Repair
Philips and Edwards Lifesciences have launched Device Guide AI, an advancement built on Philips' Echo Navigator platform. Medtech Magazine reports the AI offers cardiologists a virtual 3D model of the heart to provide real-time visualization and guidance, improving precision during mitral and tricuspid valve procedures by enhancing device tracking and support during surgery.
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Intellego Technologies CEO Arrested, $9.2M in Assets Seized in Fraud Probe
Intellego Technologies CEO Claes Lindahl was arrested November 18, 2025, by Swedish authorities investigating suspected gross fraud. Simultaneously, the company's offices were raided, and a "kvarstad" seizure order was imposed, freezing 100 million Swedish kronor of their assets. Claes Lindahl, CEO of Intellego Technologies, was arrested on November 18, 2025, by the Swedish Economic Crime Authority as part of a preliminary investigation into suspected gross fraud. Medtech Magazine reported that authorities also raided the company's premises on the same day. In addition to the arrest, investigators executed search warrants and.
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Elektachef's Former CEO Gustaf Salford Appointed as Ratos' New CEO
Gustaf Salford, previously CEO of Elekta, is now CEO of Ratos, an industrial group. He left Elekta in March after five years due to performance not meeting expectations and is now transitioning out of medtech, as Ratos possesses a diverse portfolio employing around 11,000 people in sectors like construction, technology, and infrastructure.
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Cochlear Announces Employee Notifications in Sweden Regarding Organizational Changes
Cochlear's Mölnlycke headquarters in Sweden is reorganizing, leading to job cuts. Between 20 and 30 positions are expected to be eliminated following internal communication in October, impacting the workforce of 219 Swedish employees, though the specific number is still under negotiation.
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Cochlear Announces Employee Changes in Sweden; Union Negotiations Underway
Cochlear's Swedish headquarters in Mölnlycke is undergoing reorganization, confirmed by CEO Adi Nilsson, involving union negotiations. While Cochlear has not disclosed specific numbers, an earlier report estimates 20 to 30 positions may be affected, although the company has not confirmed this.
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Essity Expands in North America with Edgewell's Women's Health Acquisition
Essity is acquiring Edgewell Personal Care's women's health business for $1 billion, which includes the Carefree, Stayfree, and o.b. brands in the U.S., the Playtex brand globally, and a Delaware production facility. The deal brings 500 employees to Essity and strengthens the company's position in the North American hygiene and health market.
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Jakob Forssmed Receives Award for Health Data Initiatives
Social Minister Jakob Forssmed is being awarded Forska Sverige's politician prize for his work in improving health data usage. Secretary-General Anna Nilsson Vindefjärd credits Forssmed and the government for starting important national strategies for health data, acknowledging the challenges involved in this area.
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Siemens to spin off 30 percent of Healthineers to shareholders
Siemens will spin off 30% of its Siemens Healthineers division to existing shareholders, relinquishing its controlling stake. Siemens will retain a significant minority ownership position in Healthineers after the transaction, which confirms earlier speculation about the strategic move. Siemens AG has officially announced the planned spin-off of a substantial portion of its Siemens Healthineers division. According to the company's press release, Siemens will distribute 30% of its Healthineers shares to existing Siemens shareholders. This transaction will result in Siemens relinquishing its controlling stake in Healthineers while retaining a significant minority.
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Post-Market Surveillance:
Post-market surveillance is a critical tool for patient safety, regulatory compliance, and continuous improvement, extending beyond simple complaint handling. The EU MDR mandates a proactive PMS approach, requiring integration with risk management and communication with regulators for safeguarding patients and company viability.
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Physiotherapist Develops App to Fix Medical Device Regulation Compliance Failures
Physiotherapist Kajsa Undin created a digital support application to solve widespread issues regarding Medical Device Regulation (MDR) compliance within healthcare facilities. Undin, as Medically Responsible for Rehabilitation, noticed significant failures in tracking and controlling medical devices over three years in both private and municipal care settings, leading her to develop the innovative application.
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Synchron Secures $200 Million to Advance Brain-Computer Interface
Synchron secured $200 million to commercialize its Stentrode brain-computer interface, a less invasive technology designed to allow paralyzed individuals to control digital devices with their thoughts. The Stentrode, currently undergoing clinical trials in the U.S. and Australia with ten patients, aims to offer a safer alternative to open-brain surgery.
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Permobil Appoints Mark Elliott as EVP of Quality & Regulatory
Mark Elliott has been appointed Permobil's Executive Vice President of Quality & Regulatory, leading global operations and joining the executive management team as part of a company reorganization. This promotion from VP of Quality for the Americas aims to improve product development and manufacturing, following a recent report of Permobil eliminating 30 positions in Sweden.
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Permobil to lay off 30 amid AI, production reorganization
Permobil announced a restructuring on November 3, 2025, resulting in up to 30 job losses in Sweden, with 25 in Sundsvall and 5 in Stockholm. The changes aim to boost innovation and streamline production by shifting resources to areas like AI, creating a flatter organization with fewer decision-making layers to remain competitive.
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Mölnlycke Partners in Medical Plastic Waste Recycling Project with Sabic
SABIC and Zuyderland Medical Center, in partnership with several other companies, conducted a successful pilot recycling non-contaminated medical plastic waste. The program collected plastic waste from the medical center starting in June 2024, which SABIC then converted into certified circular polyethylene, used to produce new medical packaging.
Photo by Teslariu Mihai on Unsplash
Olympus Restructures, Cutting 2,000 Jobs to Streamline Operations
Olympus announced on November 7, 2025, that it will restructure its organization, moving from a region-led to a division-based model. As part of this reorganization, the global medical technology company will reduce its workforce by approximately 2,000 positions. On November 7, 2025, Olympus, a global medical technology company, announced a significant restructuring initiative. The company will reduce its workforce by approximately 2,000 positions as part of the reorganization. This restructuring shifts Olympus from a region-led organizational model to a division-based structure. The company anticipates this change will enhance operational efficiency.
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Mölnlycke Establishes Wound Care Factory in China for Growth
Mölnlycke Health Care is building its first wound care factory in China. The 10,000-square-meter facility in Changshu will produce Mepilex wound care products, with production starting in late 2026 or early 2027. Mölnlycke Health Care is establishing its inaugural wound care product manufacturing facility in China, according to Medtech Magazine. The 10,000-square-meter facility, located in Changshu, eastern China, aligns with the company’s strategy to localize production for key markets. The factory will produce wound care solutions from the Mepilex series. Production is slated to commence in late 2026 or.
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Olympus Bronchoscope Safety Guidelines Updated After Burn Incident Reports
Olympus has issued new global safety guidelines for its bronchoscopes after reports of injuries and one death. This action is separate from their recent cleaning instruction updates for duodenoscopes, which were made in response to different serious incidents. Olympus, a Japanese medical technology company, has released updated global safety guidelines for its bronchoscopes. This action follows reports of serious injuries, including airway burns and one fatality, associated with the devices. The new guidelines are distinct from the company's recent update to the cleaning instructions for its duodenoscopes, which was implemented.
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Medtech Magazine: Virtual Healthcare Could Eliminate Need for Sore Throat Doctors
TL;DR: Dr. Michael Maniaci, a physician and medical director for virtual care, stated in Medtech Magazine that healthcare accessibility has become easier for providers in the last 100 years, but more difficult for patients. Details about Dr. Maniaci's reasoning or potential remedies were not included.
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Forbes' David Chou Covers Healthcare Technology Trends, CIO Strategies
David Chou's publications provide strategic insights for healthcare CIOs on technology and industry transformations. His analysis includes AI implementation, talent alignment, event takeaways like Epic UGM 2025, and the impact of technologies such as ambient AI and Doximity's tool. He also examines IT infrastructure management, focusing on auto-update strategies after events like the 2024 CrowdStrike outage.
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WSJ reports women seek alternatives to hormonal birth control
Many women in their twenties and thirties are looking beyond traditional birth control like oral contraceptives to manage hormonal imbalances. They are proactively exploring alternative, potentially more self-directed, solutions to address their health concerns, as reported by The Wall Street Journal.
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Profundus Appoints Neven Zoric as CEO for Eye Camera Launch
Neven Zoric will become CEO of eye diagnostics company Profundus on November 5, 2025, to lead the commercialization of their eye camera and expand the market for their diagnostic technology. Zoric brings over 20 years of experience from life science companies like Vitrolife Group and Thermo Fisher Scientific to Profundus.
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UltraGreen.ai Starts Gauging Interest for Singapore IPO, Bloomberg Reports
Singapore's UltraGreen.ai, a fluorescence technology company, is considering an IPO in Singapore and has begun investor education meetings. Sources indicate the company aims to raise roughly $400 million through the listing, which could happen as early as December. UltraGreen.ai, a Singapore-based company specializing in fluorescence technology for surgical imaging, is exploring a potential initial public offering (IPO) in Singapore, according to Bloomberg.com. The company has commenced investor education meetings, signaling its intent to gauge investor interest. Sources familiar with the matter suggest UltraGreen.ai aims to raise approximately $400 million.
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Associated British Foods Mulls Primark Separation: Stock Movers Report
TL;DR: Associated British Foods is considering separating Primark from its other businesses. Telefonica shares sharply declined after announcing a 50% reduction in its 2026 dividend, while Royal Philips' stock price increased due to better-than-expected third-quarter adjusted EBITA. Associated British Foods is undertaking a strategic review that may result in the separation of its Primark clothing retail business from its other operations. In separate news, Telefonica shares experienced a significant decline, the largest in over five years. This drop in value for Spain's largest telecom operator by revenue followed the announcement.
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Waters Corp Raises Profit Forecast Due to Lab Equipment Demand
Waters Corporation raised its annual profit outlook due to a strong third quarter where they beat analyst predictions with $3.40 earnings per share on $800 million revenue, driven by higher demand from biotechnology companies. Consequently, the company now anticipates a full-year adjusted profit between $13.05 and $13.15 per share, and shares jumped almost 10% following the news.
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Pfizer Sues Novo Nordisk over Metsera Deal Antitrust Allegations
Pfizer is suing Novo Nordisk for anticompetitive behavior regarding their competing bids for Metsera, alleging that Novo Nordisk's $9 billion offer and proposed 30-month closing period aims to delay Metsera's obesity treatment and protect Novo Nordisk's market share. Novo Nordisk and Metsera deny these claims, stating their intentions are to accelerate the commercialization of Metsera's assets, while suggesting that Pfizer is trying to lower the acquisition price.
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