Regulation — older stories
188 stories beyond the latest 40.
- 041RegulationSource · Medical Device Network
FDA clears Myrava’s patient-specific bolus device
Myrava received 510(k) clearance from the FDA for its patient-specific, 3D-printed bolus device designed for use in radiation therapy. The device is manufactured using 3D printing technology to customize bolus shapes for individual patients during treatment.
- 042RegulationSource · Medical Device Network
FDA approves Cordis SELUTION SLR for coronary in-stent restenosis
The US FDA has approved Cordis' SELUTION SLR (sustained limus release) drug-eluting balloon for treatment of coronary in-stent restenosis. The approval expands the indication for the device beyond its previous clearance.
- 043RegulationSource · Medical Device Network
Koning Health secures Australian TGA approval for breast CT system
Koning Health has received Australian Therapeutic Goods Administration approval for its Koning Breast CT System. The clearance expands the vendor's regulatory footprint in the Asia-Pacific region for breast imaging applications.
- 044RegulationSource · Medical Device Network
FDA clears Neptune Medical’s Triton 1 system for colon procedures
Neptune Medical received FDA clearance for its Triton 1 System, a robotic platform designed to assist with flexible endoscopy procedures throughout the colon. The clearance enables market entry for the robotic-assisted colonoscopy device.
- 045RegulationSource · Medical Device Network
FDA clears Medtronic’s LigaSure RAS Maryland device
Medtronic received FDA clearance for the LigaSure RAS Maryland jaw device, designed for use with its Hugo robotic-assisted surgical system. The clearance expands the company's minimally invasive surgical portfolio.
- 046RegulationSource · Medical Device Network
Intuitive receives CE mark for transvaginal use of da Vinci SP system
Intuitive Surgical has obtained CE mark approval for transvaginal use of its da Vinci SP single-port robotic surgical system in gynecologic procedures. The clearance expands the approved applications for the platform in European markets.
- 047RegulationSource · MedCity News
Nutromics Nabs FDA Breakthrough Status for Antibiotic Monitoring Patch
Nutromics received FDA breakthrough device designation for a wearable patch that monitors vancomycin levels in real time, intended to eliminate periodic blood draws for antibiotic dosing. The designation accelerates the regulatory pathway for the continuous monitoring technology.
- 048RegulationSource · Medical Device Network
Nutromics’ drug monitoring patch secures FDA breakthrough designation
Nutromics has received FDA Breakthrough Device designation for its wearable drug-monitoring patch, which tracks vancomycin levels. The designation accelerates review pathways for the platform and signals FDA recognition of the technology's potential clinical value in therapeutic drug monitoring.
- 049RegulationSource · Medical Device Network
XCath secures FDA breakthrough designation for remote thrombectomy robot
XCath has received FDA Breakthrough Device designation for its remote thrombectomy robot system, which aims to expand access to stroke treatment. The designation supports continued development of the remote-operated surgical platform.
- 050RegulationSource · Medical Device Network
J&J’s new reusable contact lens secures CE Mark
Johnson & Johnson received CE Mark approval for ACUVUE OASYS MAX 2-Week, a reusable contact lens incorporating MAX technology. The clearance enables market distribution in Europe for the two-week wear modality.
- 051RegulationSource · Medical Device Network
FDA grants 510(k) clearance to Emboliner system for TAVR procedures
Emboline received FDA 510(k) clearance for its Emboliner embolic protection system, designed for transcatheter aortic valve replacement (TAVR) and related cardiac procedures. The clearance enables the company to market the device in the US for use during these interventional cardiology procedures.
- 052RegulationSource · Medical Device Network
Abbott’s dual ablation catheter lands FDA approval
Abbott received FDA clearance for its TactiFlex Duo dual ablation catheter, following the device's CE mark approval in January 2026. The catheter enables physicians to perform both radiofrequency and cryoablation procedures using a single device, intended for cardiac arrhythmia treatment.
- 053RegulationSource · Medical Design & Outsourcing
This de novo minimally invasive system was designed for safer hysterectomies
Claria Medical received FDA de novo classification in July 2026 for a minimally invasive hysterectomy system designed to reduce container breach rates and associated risks of cancer spread or bowel injury. The Mountain View, California-based company developed the device to address limitations in current surgical approaches for one of the most common gynecological procedures.
- 054RegulationSource · Medical Device Network
Powerful Medical’s AI heart attack detection model secures FDA approval
Powerful Medical received FDA approval for Queen of Hearts, an AI model that analyzes ECG readings to detect STEMI and STEMI-equivalent patterns associated with acute coronary syndrome. The software is designed to aid in rapid identification of heart attack risk.
- 055RegulationSource · Medical Device Network
Boston Scientific’s SCS leads linked to 1,081 serious injuries in FDA alert
Boston Scientific faced an FDA alert linking its spinal cord stimulation (SCS) leads to 1,081 serious injuries. The company operates in a market where multiple medtech vendors are defending personal injury lawsuits tied to SCS system malfunctions, signaling broader reliability concerns across the spinal neuromodulation sector.
- 056RegulationSource · Medical Device Network
WHO greenlights Cepheid’s Ebola diagnostic amid ongoing Bundibugyo outbreak
The WHO has granted approval for Cepheid's Ebola diagnostic test during an ongoing Bundibugyo virus outbreak in Central Africa, declared a public emergency in May 2026. The clearance enables broader deployment of the rapid diagnostic platform to support outbreak response efforts in affected regions.
- 057RegulationSource · Medical Device Network
Globus Medical’s Excelsius3D imaging system receives CE mark
Globus Medical received CE mark approval for its Excelsius3D imaging system, enabling commercial distribution in the European Union and UK. The clearance expands the platform's market access beyond existing approvals.
- 058RegulationSource · Medical Device Network
FDA clears Heartvue’s cardiac image evaluation software
The FDA has cleared Heartvue.Proton, a software tool designed to streamline the evaluation of cardiovascular MRI images. The clearance enables the vendor to market the cardiac image analysis platform to healthcare facilities performing cardiac imaging studies.
- 059RegulationSource · Medical Device Network
FDA clears Hamamatsu NanoZoomer S20MD and S540MD slide scanners
Hamamatsu Photonics received FDA 510(k) clearance for the NanoZoomer S20MD and S540MD slide scanner systems. These digital pathology platforms enable high-resolution scanning and analysis of microscope slides for laboratory and clinical use.
- 060RegulationSource · Medical Device Network
Vara nets first CE mark for autonomous AI breast cancer screening tool
Vara received CE mark approval for its autonomous AI-powered breast cancer screening triage system. The clearance signals regulatory acceptance of the company's AI-driven approach to cancer screening workflows, as machine learning tools become more integrated into diagnostic imaging pathways.
- 061RegulationSource · Medical Device Network
Health Canada issues licences to Fujirebio’s Lumipulse assays
Fujirebio received Class II Medical Device Licences from Health Canada for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays. These blood-based biomarker tests are used in neurodegenerative disease diagnostics. The clearances expand regulatory authorization for the assays beyond prior markets.
- 062RegulationSource · Medical Device Network
FDA grants 510(k) clearance to Medibyt’s CPETWise solution
Medibyt, an Israeli digital health company, received FDA 510(k) clearance for CPETWise, a software solution designed to assist in the analysis and interpretation of cardiopulmonary exercise testing (CPET). The clearance enables the company to market the tool in the US.
- 063RegulationSource · Medical Design & Outsourcing
How Vitestro’s first-of-its-kind Aletta robot autonomously draws blood
Vitestro received FDA de novo classification in August 2026 for its Aletta robotic phlebotomy system, which autonomously performs blood draws from tourniquet placement through bandaging. The FDA designation recognizes the device as an innovative approach to blood collection addressing a critical public health need.
- 064RegulationSource · Medical Device Network
GE HealthCare secures CE mark for Photonova Spectra CT system
GE HealthCare has obtained CE mark approval for its Photonova Spectra photon-counting CT system, clearing the device for commercial distribution in European markets. The certification represents regulatory progression for the photon-counting imaging technology platform.
- 065RegulationSource · Medical Device Network
NICE recommends NHS funding for Bridge to Life’s liver perfusion system
The UK's National Institute for Health and Care Excellence (NICE) recommended NHS funding for Bridge to Life's VitaSmart liver perfusion system, one of four devices approved for routine coverage. The recommendation signals market access and reimbursement pathway clearance for the organ perfusion technology in the UK healthcare system.
- 066RegulationSource · Medical Device Network
Paradromics gets FDA nod for broader BCI device compatibility
Paradromics received FDA approval to expand compatibility of its investigational brain-computer interface (BCI) system with a broader range of personal computing devices. The clearance widens the potential integration options for the BCI platform, allowing it to work with more standard consumer and enterprise computing hardware.
- 067RegulationSource · Medical Device Network
FDA approves Abbott’s Libre Duo 10 Day dual glucose-ketone monitor
Abbott received FDA authorization for the Libre Duo 10 Day, a continuous glucose and ketone monitoring system. The device is designed for people with diabetes and claims to be the first to simultaneously track both glucose and ketone levels in a single wearable monitor.
- 068RegulationSource · Medical Device Network
Avulux lands FDA de novo classification for light-sensitive migraine lenses
Avulux received FDA de novo classification for its light-filtering lens technology designed for light-sensitive migraine sufferers. The lenses block up to 97% of blue, amber, and red light wavelengths while transmitting green light. De novo classification establishes a new regulatory pathway for the device type.
- 069RegulationSource · Medical Device Network
Guardant ordered to pay $245m in DNA sequencing patent dispute
Guardant Health was ordered to pay $245 million in a patent dispute over DNA sequencing technology. The ruling includes a 6% ongoing royalties obligation that the company plans to appeal. The case concerns intellectual property rights related to sequencing methods used in the company's diagnostic platforms.
- 070RegulationSource · Medical Device Network
Roche’s pTau217 single-biomarker Alzheimer’s blood test lands FDA approval
Roche's pTau217 blood test for Alzheimer's disease received FDA clearance, following CE mark approval in Europe in May 2026. The single-biomarker assay detects phosphorylated tau-217, a protein associated with Alzheimer's pathology, enabling blood-based diagnostic screening without requiring imaging or lumbar puncture.
- 071RegulationSource · Medical Device Network
Implantica’s anti-reflux device secures FDA approval to tee up J&J rivalry
Implantica's RefluxStop, an implantable anti-reflux device for gastroesophageal reflux disease, has secured FDA approval in the United States. The device previously received CE marking in Europe in 2018 and has been implanted in approximately 1,800 patients. The approval positions Implantica to compete in a market segment where Johnson & Johnson holds existing offerings.
- 072RegulationSource · Medical Device Network
Pulnovo Medical enrols first US patients in PULSE-LHD IDE trial
Pulnovo Medical has enrolled the first US patients in the PULSE-LHD IDE (Investigational Device Exemption) trial, evaluating PADN (pulmonary artery denervation) therapy for pulmonary hypertension with left heart disease. The trial represents a regulatory milestone for the device candidate in the US market.
- 073RegulationSource · Medical Device Network
FDA clears C2N Diagnostics’ early Alzheimer’s assessment test
The FDA has cleared C2N Diagnostics' Alzheimer's assessment test, marking the first FDA-cleared diagnostic for patients as young as 40 presenting with cognitive impairment symptoms. The clearance expands the addressable patient population for early Alzheimer's detection in clinical settings.
- 074RegulationSource · Medical Device Network
FDA clears Empatica’s platform for Parkinson’s monitoring
Empatica received FDA 510(k) clearance for its Health Monitoring Platform for Parkinson's disease, enabling the company to offer clinical-grade remote monitoring for Parkinson's patients. The clearance expands Empatica's existing remote-monitoring technology into neurology care.
- 075RegulationSource · Medical Device Network
FDA seeks input on proposed regulatory approach to GenAI-based medtech
The FDA has opened a public comment period through October 2026 on its proposed regulatory framework for generative AI-based medical devices. The agency is seeking input from stakeholders on how to govern AI-enabled medtech while maintaining safety and efficacy standards.
- 076RegulationSource · Medical Device Network
Masimo’s brain function monitor secures CE mark
Masimo, a Danaher subsidiary, obtained CE mark approval for its smartSedLine brain function monitor, a device designed to support anaesthetic management. The clearance enables the company to market the monitor in European Union member states and other regions that recognise CE certification.
- 077RegulationSource · Medical Device Network
First patient treated in FDA IDE study of Aqua Medical’s PIMA device
Aqua Medical has enrolled the first West Coast patient in RESTORE-I, an FDA-approved investigational device exemption (IDE) study evaluating its PIMA procedure for type 2 diabetes treatment in adults. The trial represents advancement of the device through the FDA's clinical investigation pathway.
- 078RegulationSource · Medical Device Network
J&J secures FDA clearance for MONARCH QUEST 3 bronchoscopy system
Johnson & Johnson received FDA 510(k) clearance for the MONARCH QUEST 3 bronchoscopy system, a navigational bronchoscopy platform designed for pulmonary diagnosis and intervention. The clearance enables the company to market the device in the US.
- 079RegulationSource · Medical Design & Outsourcing
J&J’s robotics and digital R&D head offers advice for device developers
Johnson & Johnson MedTech's Ottava surgical robotics system has received FDA de novo authorization. The company's Global Head of Robotics & Digital R&D shared insights on the product development process and regulatory pathway, offering guidance for other device developers navigating similar clearance challenges.
- 080RegulationSource · Medical Device Network
OncoSil obtains FDA humanitarian exemption for bile duct cancer treatment
OncoSil received FDA humanitarian exemption for its device designed to treat bile duct cancer. The implantable device is delivered directly into solid tumors via injection under endoscopic ultrasound guidance, enabling treatment of patients with this rare cancer type.