Devices
Clearances, approvals and launches of medical devices, with the regulatory pathway stated.
FDA Expands Instylla's Embrace Hydrogel Embolic Approval to Peripheral Arterial Bleeds
A panel-track PMA supplement adds bleeding in vessels up to 6 mm to the liquid embolic's original hypervascular tumor indication, based on the 130-patient HALT study.
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Axora Medical Launches HERizon RD5, a 5Fr Battery-Powered Uterine Polyp Resecting Device
The single-use handheld resector, cleared by the FDA in August, fits 5Fr and larger hysteroscopes and is intended for use in the office or the operating room.
Teleflex Freesolve Scaffold Gets FDA Breakthrough Device Designation for Coronary Use
The resorbable magnesium scaffold is not approved in the US; a 1,859-patient pivotal trial against the Xience drug-eluting stent is meant to support a future PMA application.
FDA Clears RIVANNA's BoneEnhance Machine Learning Module for Accuro XV Ultrasound
The 510(k) adds bone and soft-tissue labeling to a volumetric musculoskeletal ultrasound system; a fracture-detection module remains investigational.
E2 Announces FDA Clearances for Hēlo PE Thrombectomy System and Blood Return Device
Endovascular Engineering says Hēlo Return is the first blood-return system cleared for use with continuous vacuum aspiration during clot removal.
Providence Medical Technology Gets FDA Clearance for 3D-Printed CORUS PCSS 3D-T
The posterior cervical implant adds a porous titanium lattice to the company's existing CORUS PCSS design and was set to debut at the NASS meeting in San Antonio.
FDA Clears Urolution's OpenFlo Catheter, a Redesign of the Foley Drainage Tip
The Minnesota startup's indwelling urinary catheter is cleared for adults for up to 30 days; the company says comparative clinical studies come next.
FDA Clears TELA Bio's Liora, a Fully Resorbable Monofilament Scaffold
The 510(k) covers a PLGA surgical mesh indicated as temporary support in muscle flap procedures, the first implant TELA Bio says it developed entirely in-house.
FDA Approves Edwards' Autus Valve, a Pediatric Pulmonary Valve That Can Be Expanded
The polymer-leaflet valve can be widened from about 13 mm to 22 mm by balloon as a child grows; the FDA says experience with expansion is still limited.
FDA Clears SI-BONE's iFuse Granite Onyx for Spinal Fusion in Weak Bone
The 3D-printed pedicle screw system is SI-BONE's first compromised-bone product for use beyond the pelvis, aimed at loosening at the ends of fusion constructs.
FDA Clears Biolinq Shine Needle-Free Glucose Sensor for Over-the-Counter Use
The 510(k) lets adults 22 and older who do not use insulin buy the forearm-worn range sensor without a prescription, following its 2025 De Novo grant.
FDA Approves Cordis' Selution SLR, First Sirolimus Balloon Approved in the US for In-Stent Restenosis
The premarket approval rests on a noninferiority trial against mostly repeat stenting; the device missed a secondary endpoint in single-layer restenosis.
FDA Clears Medtronic's LigaSure Vessel Sealer for Use With the Hugo Surgical Robot
The 510(k) brings Medtronic's first robot-driven LigaSure instrument to US operating rooms, where Hugo is so far cleared only for urologic procedures.
FDA Clears Beta Bionics' Mint, Its First Tubeless Insulin Patch Pump
The 510(k) for the three-day, 200-unit pump came on September 11; Beta Bionics plans a pharmacy-only US launch in early 2027 while its new dosing algorithm awaits review.
Penumbra Launches Link Clot Capture Device for Use With Lightning Bolt Thrombectomy
The device grips organized clot while Penumbra's computer assisted vacuum thrombectomy pulls it into the catheter; the company released one physician's account but no trial data.
Flow Neuroscience Launches FL-100 At-Home Depression Headset in the US
The prescription tDCS headset, approved by the FDA through premarket approval in December 2025, is now being offered to US clinicians with a telehealth prescribing route.
FDA Clears Software Enhancements to Modular Medical's Pivot Tubeless Insulin Pump
The update adds adjustable bolus amounts and a revised interface ahead of the patch pump's planned full launch in the fourth quarter.
FDA Clears Two More Hamamatsu NanoZoomer Slide Scanners for Clinical Pathology
The benchtop S20MD and high-throughput S540MD join the S360MD as whole slide imaging systems cleared for reviewing digital pathology slides.
FDA Authorizes Abbott's Libre Duo, First Wearable to Track Ketones and Glucose Together
The De Novo authorization covers people with diabetes aged 2 and older; Abbott plans a US launch later this year.
FDA Grants De Novo to Avulux Lenses for Migraine-Associated Light Sensitivity
The authorization creates a new device type for light-filtering lenses, indicated for people 12 and older with episodic migraine and sold over the counter.
FDA Approves Implantica's RefluxStop Implant for Gastroesophageal Reflux Disease
The premarket approval lets the Stockholm-listed company start a targeted US launch of an implant already used in nine European countries.
FDA Authorizes Vitestro's Aletta, First Robotic Device to Draw Blood on Its Own
The De Novo grant creates a new device type for robotic venous blood collection, limited to adults in outpatient settings under a trained phlebotomist's oversight.
FDA Clears Vesalio's pVasc NET, a Peripheral Clot-Removal Device With a Built-In Filter
The Special 510(k) adds a fine-pore filter to Vesalio's nitinol pVasc device to hold clot fragments during retrieval.
FDA Clears Roen Surgical's Zamenix Robot for Flexible Ureteroscopy of Kidney Stones
The South Korean company's system lets surgeons steer a flexible ureteroscope remotely, with breathing compensation and a stone-size guide.
FDA Clears BlueWind's Revi Extend Tibial Implant for Urgency Incontinence
The next-generation implant is intended to last 15 years instead of 10; BlueWind plans a limited US launch in the fourth quarter.
FDA Clears Sight Sciences' OMNI Ultra Glaucoma Surgery System
The single-use device combines canaloplasty and trabeculotomy through one small corneal incision; a US launch is planned for the fourth quarter.
FDA Grants De Novo to Smith+Nephew's TESSA Navigation System for ACL Surgery
The system overlays a patient-specific bone model on live arthroscopic video and creates a new Class II device type for joint navigation.
FDA Approves Freenome's SimpleScreen CRC Blood Test for Colorectal Cancer Screening
Abbott will sell the cell-free DNA test in the US this fall; the FDA requires a three-year post-approval study of its performance.
FDA Approves Traferox's TorEx System for Reassessing Donor Lungs Outside the Body
The premarket approval covers normothermic perfusion of donor lungs first judged unsuitable, with two post-approval studies required.
FDA Grants De Novo to J&J's OTTAVA Table-Integrated Surgical Robot
The authorization creates a new Class II device type for operating tables with built-in robotic arms, authorized for upper abdominal laparoscopic surgery.
FDA Clears Cochlear's Osia 3 Rechargeable Bone Conduction Sound Processor
Cochlear says the new processor for its implanted Osia System adds a rechargeable battery, more high-frequency power and wider streaming support.
FDA Grants De Novo to Claria Medical's Hysterectomy Tissue Extraction System
The authorization creates a new Class II device type for contained power morcellation of gynecologic tissue not suspected to be cancerous.
FDA Clears Zeta Surgical's Robotic System for Positioning TMS Coils
The Boston company's robot holds a transcranial magnetic stimulation coil on target and adjusts it as the patient moves, the company says.