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Device IQ

New devices, and what they change in your practice.

FDA route · least to most demanding
5510(k)Cleared3De NovoGranted10PMAApproved

18 FDA decisions on file · newest

SpecialtyAll 18Cardiology 4Endocrinology 1Gastroenterology 2Neurology 1Oncology 2Ophthalmology 1Orthopedics 2Pediatrics 1Pulmonology 1Surgery 2Urology 1
Type Diagnostic test Imaging or monitoring Implant Software or AI Surgical system Therapy device Wearable or sensor
18 devicesacross all specialties · newest first
  1. Autus Size-Adjustable ValveCongenital pulmonary valve disease · PediatricsChildren who need a pulmonary valve replacement now have a surgical valve that can be enlarged by balloon catheter as they grow, which the FDA says may reduce the need for repeat open-heart surgeries. Data on expansion are limited and longer-term studies are under way.Approved · PMA Design not reported55s
  2. SELUTION SLR Drug-Eluting BalloonCoronary in-stent restenosis · CardiologyInterventional cardiologists have a sirolimus balloon option for in-stent restenosis that, per the company, helps minimize the need for another stent. The supporting trial showed non-inferiority to standard of care, which was mostly repeat drug-eluting stenting.Approved · PMA Head-to-head50s
  3. Triton 1 SystemColonoscopy and therapeutic procedures in the colon · GastroenterologyGastroenterologists may see a robotic option for screening, surveillance and diagnostic colonoscopy, as well as more complex procedures such as EMR and ESD. The evidence so far is a first-in-human study, and the company describes this generation as a step toward commercialization.Cleared · 510(k) Design not reported55s
  4. Libre DuoDiabetes: continuous ketone and glucose monitoring · EndocrinologyPatients with diabetes can now see ketone and glucose levels and trends together in real time from one device, with alerts that may help them and their caregivers recognize rising ketones before diabetic ketoacidosis becomes an emergency. The FDA notes that ketone information should always be interpreted in the context of glucose readings and symptoms.Granted · De Novo Performance testing65s
  5. SimpleScreen CRCColorectal cancer screening · GastroenterologyThe FDA has approved another colorectal cancer screening option for average-risk adults 45 and older that needs only a blood draw, with a US launch by Abbott planned for this fall. A positive result should be followed by colonoscopy, and the test detected few advanced precancerous lesions (13.7% sensitivity) in its validation study.Approved · PMA Performance testing55s
  6. OTTAVA Robotic Surgical SystemRobotic-assisted general surgery in the upper abdomen · SurgeryHospitals have a new robotic option for multiple upper abdominal general surgery procedures, with the arms built into the table. The company will launch first with select U.S. customers, and the release reports no clinical outcome data.Granted · De Novo Performance testing50s
  7. EchoNextScreening for structural heart disease from an ECG · CardiologyA routine ECG can be analyzed to flag patients who should have an echocardiogram for possible structural heart disease. Echocardiography is still required to definitively diagnose these conditions.Cleared · 510(k) Performance testing50s
  8. Nellcor pulse oximetry system with Nell-EQ intelligent processorOxygen saturation and pulse rate monitoring · PulmonologyClinicians will have a Nellcor system designed for more consistent SpO2 readings across skin tones, with sales expected in the upcoming months. The release gives no performance numbers, so the size of any improvement cannot be judged from it.Cleared · 510(k) Performance testing50s
  9. Signatera CDxMuscle invasive bladder cancer, selection for adjuvant atezolizumab · OncologyAfter cystectomy for muscle invasive bladder cancer, a positive Signatera CDx result identifies patients eligible for adjuvant atezolizumab. Patients who test negative should continue serial testing until a positive result or the end of the recommended 12-month testing window.Approved · PMA Placebo-controlled60s
  10. neuropacsDifferentiating MSAp and PSP from Parkinson's disease · NeurologyNeuroradiologists and neurologists can get a supplemental report from one diffusion MRI scan, without a radiotracer, to help differentiate MSAp and PSP from Parkinson's disease. It is not a standalone diagnostic, and patient management decisions should not be based solely on its output.Granted · De Novo Performance testing55s
  11. NEXUS Aortic Arch SystemAortic arch disease, including chronic aortic dissection · SurgeryPatients with aortic arch disease now have an FDA-approved endovascular option in the United States. The supporting trial enrolled a high-risk population.Approved · PMA Design not reported40s
  12. Asurys Fluid Management SystemIrrigation during endoscopic urologic procedures, including kidney stone treatment · UrologyUrologists get one irrigation system across several endoscopic procedures, with automatic inflow regulation tied to intrarenal pressure when used with the LithoVue Elite ureteroscope. The release does not report data showing fewer complications.Cleared · 510(k) Design not reported45s
  13. OmniaSecure defibrillation leadDefibrillation with conduction system pacing · CardiologyPatients who need both a defibrillator and pacing can now receive conduction system pacing through the defibrillation lead itself, placed in the left bundle branch area.Approved · PMA supplement Design not reported50s
  14. Trilogy Transcatheter Heart ValveSymptomatic, severe aortic regurgitation · CardiologyPatients with symptomatic, severe aortic regurgitation who are at high or greater surgical risk now have a transcatheter valve with a dedicated U.S. indication. The company plans to launch first at participating clinical study sites, then at new hospitals.Approved · PMA Single-arm50s
  15. TECNIS PureSee IOLAphakia after cataract removal, with presbyopia · OphthalmologyCataract patients have an EDOF lens option that, per its indications, improves intermediate visual acuity compared with an aspheric monofocal IOL while keeping distance acuity comparable, and whose labeling carries no warning on loss of contrast sensitivity. The company says it will be available in the U.S. later this year.Approved · PMA Design not reported70s
  16. Infuse Bone Graft for TLIFOne- and two-level TLIF lumbar spine fusion · OrthopedicsSurgeons can now use Infuse on label in one- and two-level TLIF procedures from L2-S1, with titanium or PEEK cages and multiple dose options. The release reports fusion results but no safety data.Approved · PMA supplement Head-to-head55s
  17. Stealth AXiS surgical systemSpine surgery · OrthopedicsSpine surgeons can plan, navigate and use robotic assistance on one platform instead of multiple standalone technologies. The release offers no outcome data showing a patient benefit.Cleared · 510(k) Design not reported35s
  18. Optune PaxLocally advanced pancreatic cancer · OncologyAdults with locally advanced pancreatic cancer have a wearable device option; in the pivotal study, adding it to gemcitabine and nab-paclitaxel improved overall survival by approximately two months. The device is designed to be worn during normal daily activities, and patients are trained to operate it themselves.Approved · PMA Open-label randomized45s
Approved · PMABreakthrough device

Autus Size-Adjustable Valve

Edwards Lifesciences · Pediatrics · First expandable pediatric heart valve

Type
Implant
FDA route
Premarket approval (PMA)
Bottom line for your practice
55s read

Children who need a pulmonary valve replacement now have a surgical valve that can be enlarged by balloon catheter as they grow, which the FDA says may reduce the need for repeat open-heart surgeries. Data on expansion are limited and longer-term studies are under way.

What it is
A surgically implanted pulmonary heart valve with polymeric leaflets instead of animal-derived tissue. It can be implanted as small as approximately 13 millimeters in diameter and later widened with a balloon catheter, up to 22 millimeters.
Indicated for
Pediatric patients with congenital pulmonary valve disease who need pulmonary valve replacement.
What changes
The FDA says traditional valves use animal-derived tissue, which tends to harden and break down faster in children and often requires earlier repeat surgery. The release does not describe the design of the clinical study.
Evidence
Design not reportedStudy not named in the release · n=62At the six-month follow-up, the first 60 patients demonstrated acceptable hemodynamic performance with no more than mild leakage back through the valve. All patients had a successful procedure, with no deaths, blood clots requiring additional treatment, strokes or other clot-related complications.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
Three patients had a fracture in the valve frame and two had reduced movement of one valve leaflet, none with symptoms. Valve performance began deteriorating in two patients who started to outgrow it; both were expanded successfully, but the FDA says the experience is limited and longer-term studies are being conducted.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.Breakthrough Device designation: for devices that may offer more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. It speeds the FDA's interaction and review. It does not lower the standard for authorization.

How a device reaches you

Cleared, granted, approved. Three words, three levels of evidence.

A drug is approved. A device may only be cleared. The word tells you how much clinical evidence the FDA reviewed, so every spec sheet leads with it.

  1. Step 1 of 3

    Cleared

    510(k) clearance

    Cleared, not approved. The FDA found the device substantially equivalent to one already on the market (its predicate). Clinical trials are often not required.

    5 devices on file
  2. Step 2 of 3

    Granted

    De Novo classification

    A new type of low-to-moderate-risk device (Class I or II) with no predicate. The FDA reviewed its safety and effectiveness and created a new device type, which later devices can cite as a predicate.

    3 devices on file
  3. Step 3 of 3

    Approved

    Premarket approval (PMA)

    The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.

    10 devices on file

PMA supplement

A change to a Class III device that already has premarket approval, here a new indication. The FDA reviewed the evidence for the change, not the whole device again; depending on the change, that may or may not include new clinical data.

Breakthrough device

A designation for devices that may offer more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. It speeds the FDA's interaction and review. It does not lower the standard for authorization.

How to read a spec sheet

Device evidence is not drug evidence.

Many devices reach the market without a randomized trial, and some without a clinical study at all. The signal bars say which kind of evidence the source reports.

The signal bars

How directly the study shows a clinical benefit against something else. They describe the study. They do not grade the device.

Head-to-head randomized trial
Randomized against an active treatment: the most direct evidence on how it compares with an existing option.
Sham-controlled randomized trial
Randomized against a sham procedure or inactive device: shows that it works, not how it compares with existing treatments.
Open-label randomized trial
Randomized, but patients and clinicians knew the assignment, so subjective outcomes are more open to bias.
Single-arm study
No randomized comparison group: the result is judged against historical expectations.
Performance testing
Accuracy, bench or analytical testing. The source reports no clinical outcome trial, which is common for cleared devices.
Design not reported
The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.

The rows of a sheet

FDA route
Cleared, granted or approved, and what that says about the evidence.
What it is
The device and how it works, in two sentences.
Indicated for
Who it is for, in the source's own terms.
What changes
How it differs from the current approach.
Evidence
The study, its design and the headline result. Where the source reports none, the sheet says so.
Setting and used by
Where it is used and who uses it, when the source says.
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved

Each sheet is written from one primary source, the FDA's announcement or the developer's own release, with AI assistance. A blank on the sheet means the source does not say.

As of , Clintelo's device search covers 18 FDA device decisions from February 2026 to October 2026 across 11 specialties (cardiology, endocrinology, gastroenterology, neurology, oncology, ophthalmology, orthopedics, pediatrics, pulmonology, surgery and urology): 10 premarket approvals, 3 De Novo grants and 5 510(k) clearances. The devices are Autus Size-Adjustable Valve, SELUTION SLR Drug-Eluting Balloon, Triton 1 System, Libre Duo, SimpleScreen CRC, OTTAVA Robotic Surgical System, EchoNext, Nellcor pulse oximetry system with Nell-EQ intelligent processor, Signatera CDx, neuropacs, NEXUS Aortic Arch System, Asurys Fluid Management System, OmniaSecure defibrillation lead, Trilogy Transcatheter Heart Valve, TECNIS PureSee IOL, Infuse Bone Graft for TLIF, Stealth AXiS surgical system and Optune Pax.