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Flow Neuroscience Receives FDA Approval for At-Home Depression Treatment
Flow Neuroscience, a company based in Malmö, has secured FDA premarket approval for their electric brain stimulation headset, which treats depression. U.S. clinics can now prescribe this headset for adult patients with moderate to severe major depressive disorder, making it the first FDA-approved at-home medical device for this purpose.
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Medtech Articles
50 articles found
Cenova Scales Up to Meet Growing Medtech Market Demands
Cenova, a Mjölby-based company, has transformed from a component manufacturer to a strategic development and manufacturing partner in medical technology, prompting expansion due to increasing market demand. This includes scaling production, implementing automation, and planning a new manufacturing facility to capitalize on opportunities in the evolving medical technology field.
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GE Healthcare Advances Swedish Tomography Development with Photonova Spectra
GE Healthcare unveiled its Photonova Spectra CT scanner at RSNA in Chicago, featuring Deep Silicon detector technology. The scanner offers exceptional spectral and spatial resolution for ultra-high-resolution imaging with broad coverage and is based on technology from Sweden. GE Healthcare has submitted a pre-market notification for the Photonova Spectra in the United States.
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GE Healthcare Advances Swedish Tomography Development with Photonova Spectra CT
GE Healthcare unveiled the Photonova Spectra CT system at RSNA, utilizing "Deep Silicon" photon-counting detectors initially created in Sweden. This new system aims to deliver ultra-high-resolution imaging due to its superior spectral and spatial resolution. GE Healthcare has also filed a premarket notification in the U.S. for the device.
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Amplex Bids $100 Million to Acquire and Delist Addvise Group
Swedish investment firm Amplex launched a SEK 1.05 billion public takeover bid for life science company Addvise Group, aiming to delist it from the stock exchange, according to Medtech Magazine. Amplex's offer, at SEK 1.65 per share and SEK 0.49 per warrant, signifies a 42% premium over Addvise's recent valuation.
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PR Insights for Nordic Scaleups
Survey of PR challenges among 314 Nordic startup and scaleup companies.
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OssDsign Appoints Mark Waugh as CEO to Drive US Growth
Mark Waugh will become OssDsign's CEO starting January 1, 2026, joining from Medacta USA where he was SVP – Commercial. With over 20 years in orthopedics from companies like Smith & Nephew and Medtronic, Waugh will work from OssDsign's U.S. office and his home in Indiana, concentrating on U.S. market growth.
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OssDsign Appoints Mark Waugh as CEO, Focuses on US Growth
Mark Waugh will become the new CEO of OssDsign AB, starting January 1, 2026, succeeding Morten Henneveld. Waugh, previously with Medacta USA and other firms, brings extensive experience to OssDsign, operating from the U.S. to drive growth in America and Europe.
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Suturion Receives CE Marking for Surgical Suturing Device for European Launch
Suturion, a Swedish medical device company, has received CE marking for its surgical suturing device intended for abdominal wall closure after surgery. With this regulatory approval secured, Suturion is now cleared to commercially launch and distribute the device throughout the European market, offering its advanced surgical solution to healthcare providers in the region.
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Optisense Care's smart toilet seat to be tested in healthcare
Optisense Care created the Zen Seat, a smart toilet seat equipped with radar, to monitor bowel habits in elderly and dementia care facilities. The Zen Seat tracks emptying patterns to inform caregivers about patient health. Helsingborg will be the first city to officially test the Zen Seat's effectiveness.
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Philips Advances Radiation-Free Surgical Navigation in European Hospitals
Philips is expanding the commercial availability of its Lumiguide 3D Device Guidance technology in Europe and the U.S. Lumiguide, integrated into the Azurion platform, is the first light-based system for real-time navigation within the body, offering a radiation-free alternative to X-ray imaging for minimally invasive procedures.
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Trelleborg Expands Medtech Operations with New Global Facilities
Trelleborg, an industrial group, has expanded its focus on medical technology and biopharmaceuticals by opening three new facilities globally. These facilities are dedicated to serving these industries. *Medtech Magazine* reports that Trelleborg, a global industrial group, has recently opened three new facilities worldwide dedicated to medical technology and biopharmaceuticals. These investments follow the formation of...
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Medtech CEO Predicts Healthcare's Shift Home Driven by Digitalization, Precision
Anna Lefevre Skjöldebrand, CEO of Swedish Medtech, stated in a December 8, 2025 interview that increased digitalization and advancements in precision diagnostics will cause more healthcare delivery to occur within patients' homes. She also noted that geopolitical factors, preparedness, and global competitiveness will influence the medtech industry's evolution alongside internal innovations.
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Cellavision's Bone Marrow Aspirate Application Achieves CE Marking
TL;DR: Cellavision has secured CE marking for its Bone Marrow Aspirate (BMA) Application, designed for use with Cellavision's DC-1 instrument. The software solution is intended for clinical laboratories to automate and standardize the morphological analysis of bone marrow samples, aiding in the assessment of blood abnormalities.
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B. Braun Melsungen Led by CEO Anna Maria Braun
Anna Maria Braun is the CEO of B. Braun Melsungen, a medical device company founded in 1839, and owns 10% of the company. Under her father's leadership, the company grew from $24 million in annual sales to $8 billion and employs over 64,000 people globally, offering infusion solutions, surgical instruments, and other technologies.
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Boule Diagnostics CEO Torben Nielsen Resigns After Restructuring Initiatives
Torben Nielsen is resigning as President and CEO of Boule Diagnostics, a role he began in April 2024. Nielsen led a restructuring that cut costs, stopped in-house hematology instrument development, shifted to a partner-based portfolio, and altered financial reporting to segment the company into Diagnostics and OEM Clinical Diagnostic Solutions.
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Medtech Magazine previews industry leader's 2026 expectations; limited details provided
Medtech Magazine is releasing industry profiles with executive insights on past performance and future strategies, looking ahead to 2026. A deeper strategic analysis is not yet available, as the full content will be published after the holidays. Medtech Magazine has released a preview of its upcoming industry profiles, featuring insights from leading executives regarding their expectations for 2026. The profiles will explore leaders' perspectives on both past performance and future strategies. Further strategic analysis is unavailable at this time, pending the release of the full content following the holiday season.
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Careium Appoints Tove Christiansson as New CEO, Recruited from Medcap
Tove Christiansson is now the CEO of Careium, according to Medtech Magazine. Christiansson is also Chairman of Swedish Medtech and currently leads the Hjälpmedel business area within the Medcap Group, where she serves as CEO of a portfolio company. According to Medtech Magazine, Tove Christiansson has been named the new Chief Executive Officer of Careium. Christiansson also serves as Chairman of Swedish Medtech and currently leads the Hjälpmedel business area within the Medcap Group, where she is also CEO of a portfolio company. Specifics regarding Careium's strategic objectives for this.
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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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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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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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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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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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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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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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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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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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