Innovation IQ for Physicians
The medical
innovation floor
that never closes.
New drugs, devices and procedures, summarized for your practice. Pick your specialty and see what changed.
Anatomy rendered from the Z-Anatomy model, CC BY-SA 4.0.
- innovations tracked
- 30
- specialties covered
- 16
- pending FDA decisions watched
- 5
- traced to a primary source
- 100%
Two desks
Search it the way you think about it.
A drug and a device are judged differently, so each has its own desk, its own brief and its own vocabulary.
New drugs, and what they change for your patients.
Every approval as a 60-second brief, set like a drug label: who it is for, what changes, the evidence, what to watch.
12 approvals · 5 pending FDA decisionsDevice IQNew devices, and what they change in your practice.
Implants, surgical systems, tests and software as spec sheets that lead with the FDA route: cleared, granted or approved.
18 FDA decisionsLatest updates
What changed in medicine.
Every regulatory action worth knowing, newest first. Two to three sentences each, with the cautions left in.
- FDA premarket approval· Pediatrics· 14 source lines
FDA approves the first pulmonary heart valve that can be expanded as a child grows.
The Autus Size-Adjustable Valve is a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease; it can be widened later with a balloon catheter. Approval rests on a clinical study of 62 pediatric patients at 12 U.S. sites, in which the first 60 patients showed acceptable hemodynamic performance at six months with no more than mild leakage. Three patients had a valve frame fracture, two had reduced leaflet movement, and experience with expansion is limited to two patients.
Autus Size-Adjustable Valve · Edwards Lifesciences
FDA approval· Neurology· 10 source linesFirst selective D1/D5 dopamine agonist approved for Parkinson's disease.
A once-daily oral tablet for adults with Parkinson's disease, with or without levodopa; unlike existing agonists, which act mainly on D2/D3 receptors, it selectively activates D1/D5. In TEMPO-3, as adjunct to levodopa in patients with motor fluctuations, daily 'on' time without troublesome dyskinesia rose by 1.7 hours versus 0.6 hours with placebo. Warnings include orthostatic hypotension, hallucinations, dyskinesia and impulse-control urges.
Juvmo (tavapadon) · AbbVie
- FDA premarket approval· Cardiology· 11 source lines
FDA approves a sirolimus drug-eluting balloon for coronary in-stent restenosis.
SELUTION SLR is a sirolimus drug-eluting balloon for the treatment of coronary in-stent restenosis, designed to deliver sustained drug release without leaving a permanent implant. In the SELUTION4ISR randomized trial of more than 400 patients, the primary non-inferiority endpoint was met at 12 months (per protocol 16.2% vs 14.5%); in all randomized patients, target lesion failure was 15.2% with the balloon and 13.5% with standard of care. The trial tested non-inferiority, not superiority, and the release gives no safety details.
SELUTION SLR Drug-Eluting Balloon · Cordis
- FDA 510(k) clearance· Gastroenterology· 9 source lines
FDA clears a robotic endoscopy system for procedures throughout the colon.
The Triton 1 System is a robotic flexible endoscopy system indicated for diagnostic and therapeutic procedures throughout the colon. In the first-in-human CARE 1 study, the system met its primary endpoints with no adverse events and 100% cecal intubation, and showed an adenoma detection rate of 54.2%. An investigator quoted in the release anticipates additional clinical research as the system moves toward commercialization.
Triton 1 System · Neptune Medical
- FDA approval· Hematology· 10 source lines
FDA approves the first hepcidin mimetic for adults with polycythemia vera.
Mimrylo is a once-weekly subcutaneous hepcidin mimetic for adults with polycythemia vera. In the phase 3 VERIFY trial of 293 adults who required frequent phlebotomies despite standard-of-care therapy, 76.9% of patients on Mimrylo required no phlebotomies compared to 32.9% on placebo. The most common adverse reactions were injection site reactions and anemia.
Mimrylo (rusfertide) · Takeda
- FDA approval· Rheumatology· 11 source lines
FDA approves the first oral treatment for dermatomyositis in adults.
Lisraya is a once-daily oral JAK/TYK2 inhibitor approved to treat dermatomyositis in adults. In a phase 3 placebo-controlled study of 241 adults, participants on Lisraya 30 mg had a higher average Total Improvement Score at week 52 than those on placebo and were more likely to reduce corticosteroid use by week 48. It carries a boxed warning for serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events, and thrombosis.
Lisraya (brepocitinib) · Priovant Therapeutics
- FDA approval· Oncology· 7 source lines
FDA approves a once-daily RAS inhibitor for metastatic pancreatic adenocarcinoma.
Rasonque is a once-daily oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In a randomized, open-label trial of 500 previously treated adults, median overall survival was 13.2 months with Rasonque compared to 6.7 months for standard chemotherapy. The most common side effects include rash, diarrhea, stomatitis, nausea and fatigue.
Rasonque (daraxonrasib) · Revolution Medicines
FDA De Novo· Endocrinology· 8 source linesFirst wearable sensor that tracks ketones and glucose together.
A 10-day sensor for people with diabetes aged 2 and older that measures ketones and glucose in interstitial fluid every minute and sends readings, trends and rising-level alerts to a smartphone. Across six clinical studies in more than 600 participants it tracked clinically meaningful ketone differences, including elevated ketones before the onset of diabetic ketoacidosis. Ketone readings should be interpreted with glucose values and symptoms, and do not replace confirmatory testing before treatment decisions.
Libre Duo · Abbott
FDA approval· Gastroenterology· 8 source linesFDA approves a blood test for colorectal cancer screening in average-risk adults 45 and older.
A cell-free DNA blood test approved for colorectal cancer screening in average-risk adults aged 45 and older; Abbott plans to commercialize it in the US this fall. In PREEMPT CRC (more than 48,000 participants), sensitivity for colorectal cancer was 81.1% and specificity for advanced colorectal neoplasia was 90.4%, but sensitivity for advanced precancerous lesions was 13.7%. A positive result should be followed by colonoscopy, and the test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
SimpleScreen CRC · Freenome
FDA De Novo· Surgery· 10 source linesThe first soft-tissue surgical robot with its arms built into the operating table.
Authorized for upper-abdominal general surgery, including Roux-en-Y gastric bypass, sleeve gastrectomy, cholecystectomy, fundoplication and hiatal hernia repair. Its four robotic arms are integrated into the operating table rather than mounted on carts, which the company says takes 30 to 50% less floor space. It is a first-generation system in a limited US rollout, and the announcement cites no comparative outcome data.
OTTAVA Robotic Surgical System · Johnson & Johnson
- FDA approval· Cardiology· 10 source lines
FDA approves the first oral PCSK9 inhibitor to lower LDL cholesterol in adults.
Lipfendra is a once-daily 20 mg oral PCSK9 inhibitor approved as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. At week 24 it reduced LDL-C by 56% compared to placebo in CORALreef Lipids (2,904 patients) and by 59% in CORALreef HeFH (303 patients). It is not yet known whether it reduces cardiovascular morbidity and mortality; an outcomes trial is ongoing.
Lipfendra (enlicitide) · Merck
- FDA accelerated approval· Nephrology· 9 source lines
FDA grants accelerated approval to a weekly BAFF and APRIL inhibitor for IgA nephropathy.
Trutakna is a once-weekly, self-injected BAFF and APRIL inhibitor approved to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. In a prespecified interim analysis of the ongoing ORIGIN 3 trial, treated participants had a 46% reduction from baseline in proteinuria and a 42% reduction compared to placebo (p<0.0001) at 36 weeks. The approval rests on proteinuria; whether the drug slows long-term kidney function decline has not been established.
Trutakna (atacicept-vymj) · Vera Therapeutics
FDA clearance· Cardiology· 7 source linesAI flags possible hidden structural heart disease from a routine ECG.
A neural network, developed at NewYork-Presbyterian and Columbia and trained on more than 700,000 paired ECG and echocardiogram studies, that flags patients who should have an echocardiogram to look for structural heart disease. In a comparison with 13 cardiologists on 3,200 ECGs, it identified 77% of structural heart problems, while cardiologists using the ECG data had an accuracy of 64%. It is a screening tool; echocardiography is still required for a definitive diagnosis.
EchoNext · Pathway Labs
- FDA 510(k) clearance· Pulmonology· 10 source lines
FDA clears a Medtronic pulse oximetry system built for reliability across skin tones.
The Nellcor pulse oximetry system with Nell-EQ intelligent processor is a new processing technology for oxygen saturation and pulse rate monitoring across patient populations, skin tones and care settings. Medtronic says clinical studies included participants across the full range of skin tones, but the release reports no accuracy figures. Medtronic notes these products should not be the sole basis for diagnosis or therapy.
Nellcor pulse oximetry system with Nell-EQ intelligent processor · Medtronic
FDA approval· Oncology· 5 source linesA ctDNA test now selects muscle-invasive bladder cancer patients for adjuvant atezolizumab.
A circulating tumor DNA assay approved as a companion diagnostic to select patients with muscle-invasive bladder cancer who have ctDNA molecular residual disease after cystectomy for adjuvant atezolizumab, which was approved for this use the same day. In IMvigor011 (250 patients with ctDNA-detected residual disease), atezolizumab improved median disease-free survival (9.9 vs 4.8 months; HR 0.64) and overall survival (32.8 vs 21.1 months; HR 0.59) versus placebo.
Signatera CDx · Natera
- FDA approval· Cardiology· 13 source lines
FDA approves the first aldosterone synthase inhibitor as add-on therapy for hypertension.
Baxfendy is an oral aldosterone synthase inhibitor for adults whose hypertension is not adequately controlled on other agents, used in combination with other antihypertensive drugs. In the BaxHTN Phase III trial, the 2mg dose lowered mean seated systolic blood pressure by 15.7 mmHg from baseline at week 12, a placebo-adjusted reduction of 9.8 mmHg. It can cause hyperkalemia and hyponatremia, so serum potassium and sodium should be assessed before starting and monitored periodically.
Baxfendy (baxdrostat) · AstraZeneca
- FDA approval· Infectious Disease· 13 source lines
FDA approves a once-daily two-drug HIV-1 switch tablet without an INSTI or tenofovir.
Idvynso is a single tablet of 100 mg doravirine and 0.25 mg islatravir for adults with virologically suppressed HIV-1 who are on a stable regimen with no history of virologic treatment failure and no known doravirine resistance substitutions. In the double-blind Trial 052, 1% of participants switched to Idvynso had HIV-1 RNA of 50 copies/mL or more at Week 48, compared to 1% who stayed on Biktarvy, meeting non-inferiority. It is contraindicated with strong CYP3A inducers and with lamivudine or emtricitabine, and it has no activity against hepatitis B virus.
Idvynso (doravirine/islatravir) · Merck
FDA De Novo· Neurology· 12 source linesMachine-learning MRI aid helps tell MSA-P and PSP apart from Parkinson's.
Cloud software that analyzes standard 3T diffusion MRI, with no radiotracer, to help distinguish multiple system atrophy (parkinsonian variant) and progressive supranuclear palsy from Parkinson's disease. The De Novo grant created a new device category; the company cites a prospective, NIH-supported study at 21 Parkinson Study Group centers but reports no accuracy figures in its release. It is an adjunct for use after other causes of parkinsonism have been ruled out, and management should not rest on its output alone.
neuropacs · Neuropacs
- FDA premarket approval· Surgery· 3 source lines
FDA approves the NEXUS branched stent graft for endovascular repair of aortic arch disease.
NEXUS is a branched endovascular stent graft system approved for minimally invasive treatment of aortic arch disease, including chronic aortic dissections. In the NEXUS TRIOMPHE IDE trial, the company reports 90% patient survival from lesion-related death, 90% freedom from disabling stroke at 1 year and 98% freedom from reintervention due to endoleaks at one year in a high-risk population. The release gives no enrollment number, comparison group or adverse event detail.
NEXUS Aortic Arch System · Endospan
- FDA approval· Endocrinology· 12 source lines
FDA approves a once-daily GLP-1 receptor agonist tablet for chronic weight management.
Foundayo is a GLP-1 receptor agonist tablet taken once daily, approved with a reduced-calorie diet and increased physical activity for adults with obesity, or with overweight and at least one weight-related comorbid condition. Two randomized, double-blind, placebo-controlled trials showed a statistically significant and clinically meaningful reduction in body weight versus placebo after 72 weeks; the FDA announcement does not give the figures. The labeling carries a boxed warning for thyroid C-cell tumors.
Foundayo (orforglipron) · Eli Lilly
- FDA 510(k) clearance· Urology· 5 source lines
FDA clears Boston Scientific's Asurys irrigation system for endoscopic urologic procedures.
The Asurys Fluid Management System provides irrigation and distention during endoscopic urologic procedures, including ureteroscopy, cystoscopy, PCNL and BPH procedures. Paired with the LithoVue Elite ureteroscope, it can automatically regulate irrigation inflow to help keep intrarenal pressure within physician-selected settings. The release reports no clinical study data, and the U.S. launch begins as a limited market release.
Asurys Fluid Management System · Boston Scientific
- FDA approval· Oncology· 9 source lines
FDA approves relacorilant with nab-paclitaxel for platinum-resistant ovarian cancer.
Lifyorli is an oral glucocorticoid receptor antagonist given with nab-paclitaxel to adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic regimens, at least one including bevacizumab. In the ROSELLA trial of 381 patients, median overall survival was 16 months with the combination and 11.9 months with nab-paclitaxel alone (hazard ratio 0.65). It is contraindicated in patients who require corticosteroids for a lifesaving indication.
Lifyorli (relacorilant) · Corcept Therapeutics
- FDA approval· Cardiology· 7 source lines
FDA approves the OmniaSecure defibrillation lead for left bundle branch area placement.
OmniaSecure is a lumenless, 4.7 French defibrillation lead that connects to an ICD or CRT-D; its expanded indication allows placement in the left bundle branch area for conduction system pacing. In the LEADR LBBAP trial, the company reports defibrillation success at implant of 100% and an OmniaSecure-related major complication rate at three months of 2.1%. The release does not give the number of patients, and longer-term results had not yet been presented.
OmniaSecure defibrillation lead · Medtronic
FDA premarket approval· Cardiology· 7 source linesThe first transcatheter valve with a dedicated aortic regurgitation indication.
Approved for symptomatic, severe aortic regurgitation in patients a Heart Team judges to be at high or greater risk for surgical valve replacement. Where earlier TAVR valves rely on annular calcium to anchor, Trilogy clips onto the native leaflets, so it can be implanted in non-calcified valves. Approval rests on ALIGN-AR, a single-arm study with no randomized surgical comparator.
Trilogy Transcatheter Heart Valve · JenaValve Technology
FDA approval· Dermatology· 10 source linesThe first oral peptide that blocks the IL-23 receptor, approved for plaque psoriasis.
A once-daily oral IL-23 receptor antagonist for moderate-to-severe plaque psoriasis in adults and in children 12 and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. In the head-to-head ICONIC-ADVANCE 1 and 2 trials against deucravacitinib, about 70% of patients reached IGA 0/1 and 55% reached PASI 90 at week 16. It is taken on an empty stomach, at least 30 minutes before eating.
Icotyde (icotrokinra) · Johnson & Johnson
- FDA approval· Gastroenterology· 9 source lines
FDA approves the first medicine for cholestatic itch in primary biliary cholangitis.
Lynavoy is an oral ileal bile acid transporter (IBAT) inhibitor for cholestatic pruritus in adults with primary biliary cholangitis (PBC). In the GLISTEN phase III trial, it improved monthly worst-itch score versus placebo over 24 weeks (least squares mean difference -0.72 on a 0-10 scale, p=0.001). Diarrhea was reported in 61% of patients and abdominal pain in 18%.
Lynavoy (linerixibat) · GSK
FDA premarket approval· Ophthalmology· 14 source linesAn extended-depth-of-focus IOL with contrast comparable to a monofocal.
A purely refractive extended-depth-of-focus intraocular lens for primary implantation after cataract removal in adults with less than 1 diopter of corneal astigmatism. Contrast sensitivity was comparable to an aspheric monofocal IOL, and 97% of patients reported no very bothersome halos or glare. Labeling excludes several ocular comorbidities, including uncontrolled glaucoma, macular disease and diabetic retinopathy.
TECNIS PureSee IOL · Johnson & Johnson
FDA approval· Orthopedics· 14 source linesrhBMP-2 bone graft is now approved for one- and two-level TLIF.
The approval extends Infuse (recombinant human bone morphogenetic protein-2) to transforaminal lumbar interbody fusion at one or two levels from L2 to S1, with PEEK or titanium cages, in patients with up to grade 2 spondylolisthesis. A randomized trial of 493 patients comparing two rhBMP-2 doses with local autograft stopped enrollment early after meeting its primary endpoints. Medtronic reports fusion rates above 90% for single-level TLIF.
Infuse Bone Graft for TLIF · Medtronic
- FDA 510(k) clearance· Orthopedics· 7 source lines
FDA clears Medtronic's Stealth AXiS planning, navigation and robotics system for spine surgery.
Stealth AXiS is a surgical platform that combines planning, navigation and robotics in one system for spine surgery, for use in hospitals and ambulatory surgery centers. Its LiveAlign segmental tracking lets surgeons see anatomic motion and alignment in real time without repeated imaging. The release reports no clinical study data, and at the time of this clearance cranial and ENT uses were still pending.
Stealth AXiS surgical system · Medtronic
FDA premarket approval· Oncology· 8 source linesA wearable Tumor Treating Fields device for locally advanced pancreatic cancer.
A portable, non-invasive device that delivers alternating electric fields (Tumor Treating Fields) to the abdomen to disrupt cancer cell division, worn alongside gemcitabine plus nab-paclitaxel in adults with locally advanced pancreatic cancer. In the PANOVA-3 trial it extended overall survival by about two months over chemotherapy alone. Skin reactions under the transducer arrays were the most common device-related adverse event.
Optune Pax · Novocure
Specialties
Find your field.
20 specialties, one vocabulary. 16 have innovations on file today; the rest fill as new actions are verified.
- Cardiology6 innovations
- Oncology4 innovations
- Neurology2 innovations
- Orthopedics2 innovations
- Endocrinology2 innovations
- Dermatology1 innovation
- Ophthalmology1 innovation
- Gastroenterology3 innovations
- Surgery2 innovations
- Primary CareTracking
- Pulmonology1 innovation
- Urology1 innovation
- Nephrology1 innovation
- Rheumatology1 innovation
- Hematology1 innovation
- Infectious Disease1 innovation
- PsychiatryTracking
- Pediatrics1 innovation
- Obstetrics & GynecologyTracking
- RadiologyTracking
Compare
Two innovations, side by side.
Pick any two and read them against each other: regulatory action, what is new, the clinical summary and the source. Every comparison is a link you can send to a colleague.
Open the comparator- Regulatory action
- FDA premarket approval
- FDA premarket approval
- Date
- Oct 1, 2026
- Sep 21, 2026
- Specialty
- Pediatrics
- Cardiology
- What's new
- FDA approves the first pulmonary heart valve that can be expanded as a child grows.
- FDA approves a sirolimus drug-eluting balloon for coronary in-stent restenosis.
Clinician insights
In their words.
Quoted word for word from each innovation's primary source. Never paraphrased.
Can we safely and effectively treat patients with severe aortic regurgitation with a transcatheter device? The answer is yes.
Martin B. Leon, MDInterventional CardiologistOn Trilogy Transcatheter Heart Valve. Source: JenaValve press release
Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs.
Hubert Fernandez, M.D.NeurologistOn Juvmo. Source: AbbVie press release
Through EchoNext, we are able to diagnose critical, high-risk conditions that the human eye can't, and potentially deliver lifesaving treatment earlier.
Dr. Pierre EliasCardiologistOn EchoNext. Source: NewYork-Presbyterian announcement
How Clintelo works
Nothing here without a source.
As of , Clintelo tracks 30 medical innovations across 16 specialties: FDA approvals, clearances and De Novo authorizations of drugs, devices, diagnostics, AI software and procedures from February 2026 to October 2026. Each is summarized for practicing physicians and linked to the FDA announcement or the developer's own release.
We watch the primary sources
FDA announcements and the developers' own releases. Not the news cycle, not secondary reports.
We summarize for practice
What it is, the evidence and the cautions, in two to three sentences. Written with AI assistance; no figure or date is published that the source does not carry.
You verify in one click
Every innovation links straight to the document it was written from, so the summary is never the last word.
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