Press Releases
SNAQ Appoints Former Glooko CEO Russ Johannesson to Its Board of Directors | MedTech Dive
SNAQ, a clinically validated AI nutritionist company focused on diabetes, prediabetes, and metabolic health, announced the appointment of Russ Johannesson to its board of directors. Johannesson previously served as CEO of Glooko, where he built the company into the world's largest cardiometabolic connected care platform, covering 31 countries and supporting over 1.2 million patients. He will assist SNAQ in advancing its strategy for profitable scaling, partnerships, and fundraising.
Proscia Receives New FDA 510(k) Clearance for Concentriq AP-Dx with Predetermined Change Control Plan | MedTech Dive
On August 6, 2026, Proscia announced that its Concentriq AP-Dx digital pathology platform received a new 510(k) clearance from the U.S. FDA, adding compatibility with the Leica Aperio GT 450 DX scanner, cloud deployment, and a Predefined Change Control Plan (PCCP). The PCCP allows Proscia to validate and support additional FDA-cleared scanners, image formats, and displays without requiring additional 510(k) submissions. The platform previously received its initial clearance for the Hamamatsu NanoZoomer S360MD scanner in February 2024 and has obtained CE marking. Proscia achieved the highest customer integration goal support score in the KLAS 2026 Digital Pathology report, serving laboratories managing 12 million cases annually and 16 top pharmaceutical companies.
NIPRO Receives FDA 510(k) Clearance, ELISIO™-HX Dialyzer to Enter the U.S. Market
Osaka, Japan — NIPRO CORPORATION announced on July 30, 2026, that its ELISIO-HX dialyzer has received FDA 510(k) clearance from the U.S. (effective July 28, 2026), thereby introducing its HDs therapy to the United States. HDs is an innovative solution developed by NIPRO in the expanded hemodialysis field, aimed at enhancing the removal of middle- and large-molecular-weight toxins using existing dialysis infrastructure and clinical workflows.
NIPRO Launches Expanded Hemodialysis with ELISIO™-HX to U.S. Providers Following FDA Clearance | MedTech Dive
NIPRO CORPORATION announced the U.S. commercial launch of ELISIO-HX, a medium-cutoff dialyzer with super high-flux membrane technology, following FDA 510(k) clearance. The device is designed to enhance middle molecule removal while preserving albumin, and is compatible with existing dialysis machines, aiming to broaden access to expanded hemodialysis (HDs) across U.S. providers.
VisionMed Adds Three International Leaders in Robotic Surgery and Advanced Endoscopy to Medical Advisory Board | MedTech Dive
On August 18, 2026, VisionMed announced that three internationally recognized leaders in robotic surgery, advanced endoscopy, bariatric and metabolic interventions, colorectal surgery, and procedural education have joined its Medical Advisory Board. Together, these three experts will provide clinical guidance for the EMMA® platform, helping to transform surgical videos into structured documentation and procedural insights.
MedSource Labs launches ClearSafe Comfort® Closed System, rounding out its full line of peripheral IV catheters | MedTech Dive
On August 18, 2026, MedSource Labs announced the launch of the ClearSafe Comfort® Closed System, a slide-activated safety peripheral intravenous catheter with an integrated extension tube that has received FDA 510(k) clearance. The product is designed to enhance patient and clinical safety, reduce the number of venipunctures and waste, and improve patient comfort.
CLEIO Expands Integrated Product Development Capabilities for Medical Devices and Digital Health | MedTech Dive
CLEIO, an ISO 13485-certified product development and engineering firm, announced the expansion of its integrated product development capabilities for regulated medtech and digital health markets across the United States and Canada, following investments made throughout 2025 and early 2026.
Radiopaque, Polymer-Based Embolic Coil Tops 125 Implants, With Minimal Artifacts in CT, MRI Imaging | MedTech Dive
Embolization, Inc. announced that its polymer-based embolization coils have been implanted in over 125 cases cumulatively, covering a variety of arteriovenous indications. The device, which received FDA 510(k) clearance, is designed to reduce artifacts in CT and MRI imaging while maintaining radiopacity.
Incuvate Files Patent Infringement Lawsuit Against Penumbra | MedTech Dive
Incuvate, LLC announced that it has filed a patent infringement lawsuit against Penumbra, Inc., alleging that the latter's newly launched THUNDERBOLT system and related products infringe five of its patents. The case has been submitted to the United States District Court for the Northern District of California, where Incuvate seeks damages and injunctive relief.
Navigating the EU MDR and AI Act: Grayde.ai Releases a Guide for AI-Enabled Devices | MedTech Dive
Grayde.ai has released a new guide addressing the overlapping regulatory requirements of the EU Medical Device Regulation (MDR) and the EU Artificial Intelligence Act (AI Act) for AI medical devices, providing a practical path from data to deployment. The guide covers applicability determination, timelines, dataset traceability, bias testing, clinical validation, and post-market surveillance, and includes two case studies.