The FDA decisions that matter to founders, backed by a tracker of every 510(k) clearance and original PMA approval from the last 12 months.
FDA cleared the combined use of Solventum's Restrata Synthetic Electrospun Fiber Matrix and its V.A.C. Therapy system on October 19. Restrata came to Solventum with its December 2025 purchase of Acera Surgical.
FDA approved the Haemonetics PerQseal Elite vascular closure system on October 19 for procedures using 14F to 22F sheaths. The bioabsorbable patch seals arteriotomies up to 26F from inside the vessel.
Masimo said on October 17 that FDA cleared an atrial fibrillation feature for its Radius VSM wearable monitor. The company reports 97 percent sensitivity and 100 percent specificity against clinician read ECG strips, and the cleared use is to supplement AFib screening in adults 18 and older.
FDA cleared Sequel Med Tech's twiist automated insulin delivery system for adults with insulin-treated type 2 diabetes. The 307-patient pivotal trial cut HbA1c by 0.7 points and raised time in range from 57 percent to 73 percent.
SimBioSys cleared TumorSight Risk, software that estimates five and ten year breast cancer recurrence risk from an MRI the patient already had. Validation covered 2,129 retrospective patients across four health systems.
Stryker won 510(k) clearance for Sonopet 3, an ultrasonic platform for removing bone and soft tissue. First clinical cases are set for October 2026, with a full commercial launch later in the fall.
Gore said on October 14 that FDA expanded the Viabahn VBX indication to cover bridging stent use in fenestrated and branched aortic repair. Three year EMBRACE registry data put vessel level primary patency at 97.5 percent in FEVAR and 94.0 percent in BEVAR.
FDA cleared a 6 French model of Vantis Vascular's CrossFAST delivery system under K262817 on September 18, 2026. The San Jose company announced the clearance on October 13 and will launch the model in November.
FDA cleared Providence Medical Technology's CORUS PCSS 3D-T, a 3D printed porous titanium version of its posterior cervical implant. The San Antonio company announced the 510(k) on October 13 and showed the device at NASS.
Endovascular Engineering, which goes by E2, said on October 12 that FDA cleared the Helo Thrombectomy System and Helo Return in two 510(k)s. The catheter crosses at 15F, opens a 24F clot ingestion funnel, and the second device filters aspirated blood and returns it to the patient.
RingConn received FDA 510(k) clearance under K260490 for non-invasive blood oxygen measurement on its smart ring, announced October 10, 2026. The ring is made by Shenzhen Ninenovo Technology, founded in 2021 and selling in more than 190 countries.
Urolution Medical cleared the OpenFlo urinary catheter through 510(k) on October 9. The Maple Grove, Minnesota company redesigned the tip and drainage path of a conventional Foley and says it builds the device in silicone at comparable cost.
FDA granted BridgeSource Medical a De Novo for SmartRead, a handheld unit that identifies the maker of a patient's pacemaker or defibrillator in about 20 seconds. The five-person Austin company built it on NIH small business awards.
FDA cleared Argus Cognitive's Neurora under K260064, announced October 8. The software scores more than 100 vocal, facial and gaze measures from video of a standard behavioral assessment in children 18 months through 12 years.
FDA expanded the indication for Okami Medical's LOBO vascular occlusion system to peripheral venous embolization, announced October 8, 2026. Okami points to pelvic venous disease and portal hypertension as the conditions it opens.
FDA cleared Wellysis' S-Patch CardioAI on September 25 under K254255, product code DPS. The Samsung SDS spinoff announced it on October 8 and will license the analysis to monitoring providers on subscription or per-test pricing.
FDA cleared CraniUS Therapeutics' NeuroPASS 2 cranioplasty plate on September 11, 2026 under K262874. It is the Baltimore company's second clearance in about six weeks, after NeuroPASS 1 cleared July 29 under K261058.
FDA cleared MRI2CT's NextMR, announced October 7. The software builds 3D bone visualizations of the lumbar spine and sacrum from conventional MRI sequences, with no CT scan and no added radiation.
HeartSciences cleared the MyoVista wavECG under K260005 on October 6, 2026. The clearance covers the 12-lead resting electrocardiograph only, and not the company's AI-ECG algorithm.
FDA approved updated software for Abbott's CardioMEMS HF System on October 6, 2026. A new app, CardioGuide HF, puts pulmonary artery pressure readings on the patient's phone for the first time.
Click Therapeutics cleared Motivista through 510(k) on October 5, 2026. The prescription app treats negative symptoms of schizophrenia in patients 18 and older as an add-on to clinician-managed antipsychotic therapy.
FDA approved the Edwards AUTUS valve on October 1, a surgical pulmonary valve implanted at 13 mm in children and later widened by balloon catheter to as much as 22 mm. It is the first US heart valve approved with polymeric leaflets instead of animal tissue.
BTL said on October 1 that FDA cleared three new uses for its EXOMIND brain stimulation platform, including adjunctive treatment of obsessive compulsive disorder and major depressive disorder in patients 15 to 21. The company did not publish the K numbers.
Medtronic reported FDA clearance and a CE mark for Affera Prism-2 mapping software on September 30. A PulseSelect adapter that reads catheter proximity got a CE mark only.
FDA cleared a Ceribell System software update on September 30 under K261712. It adds alpha-delta ratio trending, burst suppression monitoring and amplitude-integrated EEG, with no age restriction on the labeling.
FDA cleared VertigoDx's SmartVertigo Vestibular Assessment System under K260566 on July 30, 2026. The Miami company announced it two months later, on September 30.
FDA cleared VCD Medical's VEnice vein closure device on September 29 for percutaneous and surgical closure of superficial and perforator veins. It delivers an implantable clip through a 17-gauge needle applicator under ultrasound guidance.
FDA cleared SI-BONE's iFuse Granite Onyx on September 28. The Breakthrough-designated implant targets screw loosening at the upper and lower instrumented vertebrae in patients with low bone density.
Route 92 Medical said on September 28 that FDA cleared the FreeClimb 46 Catheter with Tenzing 4, a neurovascular access and aspiration pair built for smaller, more distal vessels. It joins the FreeClimb 54, 70 and 88.
Insera Therapeutics said on September 28 that FDA cleared its CLEAR Aspiration System under K253404. The indication covers fresh, soft emboli and thrombi in peripheral arteries and veins.
Boston Scientific announced FDA 510(k) clearance of SpaceOAR Flex Hydrogel under K262151 on September 25, 2026. The spacer ships in a single syringe and lets the physician pause partway through injection to check placement.
Intuitive has a CE mark for adult cardiac surgery with the da Vinci 5, covering coronary artery bypass, mitral and tricuspid repair, mitral replacement and left atrial appendage closure. FDA cleared nine cardiac procedures for the system in the US on January 26.
Marani Health won 510(k) clearance on September 24 for the M•care System, a prescription home monitor for fetal and maternal heart rate. The Minneapolis company is aiming at 2027 availability.
FDA cleared Biolinq Shine for over-the-counter sale on September 24, covering adults 22 and older who are not on insulin. The needle-free forearm patch won a De Novo classification a year earlier for prescription use.
FDA cleared TriSalus Life Sciences' TriNav Advance on September 23, 2026 for liver embolization and a broader set of embolization procedures. The catheter runs in a telescoping mode for small distal vessels and a high-flow mode through its own lumen.
FDA cleared Xenix Medical's Riva Anchor Spinopelvic Fixation System on September 22, 2026. The Orlando company is preparing a limited commercial launch of the implant.
FDA approved Cordis's Selution SLR drug-eluting balloon on September 21 for coronary in-stent restenosis. It is the first sirolimus-coated balloon approved in the United States.
Emanate Biomedical said on September 17 that FDA cleared Perio PODS, patient-matched dental trays preloaded with an engineered hydrogel. The company has raised $11 million and plans a phased US launch in 2027.
FDA cleared Medtronic's LigaSure RAS Maryland instrument for the Hugo robotic-assisted surgery system. It seals and cuts vessels, thick tissue and lymphatics up to 7 mm, at about two seconds per seal.
Aptitude Medical Systems won its first 510(k) on September 16 for the next generation Metrix COVID test. The clearance covers over the counter use and professional use in CLIA waived settings.
FDA cleared Neptune Medical's Triton 1 robotic endoscopy system for diagnostic and therapeutic procedures throughout the colon. The Burlingame, California company announced it on September 16, making Triton its second cleared product after the Pathfinder overtube.
UpFront Diagnostics said on September 16 that its LVOne test carries a CE mark, the first blood test certified in Europe to diagnose stroke. It pairs GFAP and D-dimer and returns a result in about 10 minutes.
FDA approved Abbott's Aveir VR Mini ventricular leadless pacemaker on September 15. At 32.5 mm it runs 14 percent shorter than the 38.0 mm Aveir VR it follows, and it pairs with the Aveir AR2 atrial implant.
ZBeats said on September 15 that FDA cleared ZBPro Diagnostic v2.0 under K261580. The Stony Brook company's software now handles recordings from one minute to 14 days, covering wearable patches as well as Holter monitors.
Microstructure Imaging said on September 15 that FDA cleared MICSI-PET, software that uses a patient's structural MRI to denoise and sharpen neurological PET scans. It is the Brooklyn company's second 510(k), after MICSI-RMT cleared under K241121 in July 2024.
FDA cleared Beta Bionics' Mint insulin patch pump on September 14, 2026. The company set a first quarter 2027 launch and cut 2026 revenue guidance to $121M to $126M, expecting about $10M of fourth quarter orders to slip while customers wait for Mint.
Intuitive announced on September 14 that the da Vinci SP single-port system carries a CE mark for transvaginal gynecologic procedures, which the company calls a first for the platform.
Omniscient Neurotechnology won 510(k) clearance on September 11, 2026 for Quicktome Deep Brain, software that localizes deep brain stimulation leads and maps the white matter tracts around them. It is the Sydney company's third clearance on the same connectomics platform.
Bausch + Lomb announced CE mark approval on September 10, 2026 for SeeLyra, a femtosecond laser with live swept source OCT for cataract, LASIK flap and corneal surgery. The company is still seeking US approval and has not named a date.
FDA cleared the CraniUS Plate under K261058 on September 9, 2026, a patient-specific implant indicated for the repair of cranial defects. It is the structural first product of the Baltimore company's NeuroPASS platform, which aims to put sensing and drug delivery under the skull.
FDA granted 510(k) clearance to Emboline's Emboliner Embolic Protection System for transcatheter aortic valve replacement on September 9, 2026. The clearance rests on PROTECT H2H, a randomized IDE study that compared the device directly with Boston Scientific's Sentinel.
FDA cleared Ropca's Arthur robot and Diana analysis software on September 9, 2026, for capturing and reading ultrasound images of finger, hand and wrist joints. The Danish system has been on sale in the European Union since 2022 and has run more than 5,400 scans across six countries.
FDA cleared LUMA Vision's VERAFEYE platform as an anatomical imaging and guidance system for cardiac electrophysiology, the Dublin company said on September 9. Commercial launch is set for early 2027.
Abbott won FDA approval on September 8 for the TactiFlex Duo Ablation Catheter, which delivers pulsed field and radiofrequency energy from a single tip. Commercial cases start in the coming weeks.
FDA cleared Bioretec's ActivaScrew Cannulated COM on September 8, a headless self-reinforced PLGA compression screw for extremity fixation. The Finnish company says more than 500,000 Activa implants have been distributed.
FDA approved Guardant360 CDx on September 4 as the companion diagnostic for AstraZeneca's Etcamah (camizestrant) in ESR1-mutated advanced breast cancer. It is the first FDA approved liquid biopsy used for serial monitoring in the disease.
FDA granted Powerful Medical a De Novo under DEN250044 for Queen of Hearts, an AI model that reads 12-lead ECGs for STEMI and STEMI-equivalent patterns. The model already carries a CE mark as a Class IIb device and holds Breakthrough Device designation from March 2025.
Globus Medical's Excelsius3D imaging system received a CE mark for spine and cranial procedures in the EU and UK on September 4, 2026. The FDA cleared the same system about five years earlier.
ArthroTAK announced on September 4 that FDA cleared expanded indications for its sutureless PEEK tendon anchor, adding lateral extra-articular tenodesis in the knee. The Orlando, Florida startup's first clearance, K252635, came on May 1, 2026 for biceps tenodesis after a 254-day traditional 510(k) review.
FDA cleared software enhancements to Modular Medical's Pivot tubeless insulin patch pump on September 3, 2026, including customizable bolus dosing. The San Diego company plans a full commercial launch in the fourth quarter.
Berlin-based Vara received CE certification under the EU MDR for a Class IIb autonomous triage function that reports clearly normal screening mammograms without a radiologist reading them. The company announced the certificate on September 2, calling it the first for autonomous AI in breast screening.
MiniMed received a CE mark for its Flex insulin pump with the Simplera Sync sensor and plans a European launch in November 2026. The FDA cleared the same system in March 2026.
FDA granted De Novo authorization to Vitestro's Aletta on August 19, 2026, the first device that performs a venous blood draw with no hands-on operator. The Utrecht company raised a $70M Series B in March, led by Labcorp Venture Fund, Mayo Clinic and Sutter Health.
FDA cleared Jupiter Endovascular's Vertex Thrombectomy System (K261523) on August 4, 2026, for removing emboli and thrombi from the pulmonary arteries. The Menlo Park startup filed the traditional 510(k) on May 7, two weeks before presenting its 123-patient SPIRARE II results at EuroPCR.
FDA cleared Wandercraft's Eve exoskeleton (K260381) on August 3, 2026, for adults with spinal cord injury at any level to walk hands-free at home. The Paris company, which raised a $75M Series D in June 2025 with Renault Group and Bpifrance, plans a U.S. launch on September 17.
FDA granted Caristo Diagnostics a De Novo (DEN250042) for CaRi-Heart on July 28, 2026, creating a new class of predictive indicator for long-term cardiovascular outcomes. The Oxford spinout's software quantifies coronary inflammation from routine coronary CT angiography and reports a 10-year cardiac mortality risk.
FDA granted premarket approval to Freenome's SimpleScreen CRC (P250029) on July 24, 2026, a blood-based colorectal cancer screen for average-risk adults 45 and older. The approval earns Freenome a $100M milestone from Abbott, which holds exclusive U.S. commercial rights, three days after the company began trading on Nasdaq.
FDA approved Traferox's TorEx Lung Perfusion System (P250025) on July 15, 2026, for ex vivo perfusion of donor lungs initially judged unsuitable for transplant. The Mississauga company was founded in 2021 as a spinout of University Health Network's Toronto General Hospital.
FDA granted Claria Medical a De Novo (DEN250034) on July 2, 2026, for the Claria System, a contained tissue removal device for hysterectomy. The grant-funded Mountain View company reported a median four-minute extraction time for large uteri in its multinational controlled study.
FDA approved HepQuant's SHUNT Liver Diagnostic Test (P220016) on June 18, 2026, to flag compensated cirrhosis patients who can skip a varices screening endoscopy. FDA received the Colorado company's application on September 14, 2022, a 1,373-day review.
FDA approved CyndRx's AbsorbaSeal 5.6.7F Vascular Closure Device (P230038) on June 5, 2026, for femoral arterial access sites after procedures using 5F to 7F sheaths. The Brentwood, Tennessee company filed the PMA in November 2023 on the strength of the 220-patient SEAL TO HEAL IDE trial.
FDA granted Cardiosense a De Novo (DEN250057) on May 22, 2026, for software that estimates wedge pressure from its chest-worn CardioTag sensor in HFrEF patients. The Chicago company cleared the sensor itself under a 510(k) in July 2025.
FDA approved Endospan's NEXUS Aortic Arch Stent Graft System (P250033) on April 2, 2026, for chronic dissections involving the aortic arch in high-risk surgical patients. Artivion, which distributes NEXUS in Europe, now has 90 days to exercise an option to buy the 50-person Israeli company.
FDA approved JenaValve Technology's Trilogy Transcatheter Heart Valve System (P250024) on March 17, 2026, for symptomatic, severe aortic regurgitation in patients at high surgical risk. The decision came two months after a federal judge blocked Edwards Lifesciences' $1.2B bid for the Irvine company.
FDA cleared Perfuze's Millipede System (K253590) on March 16, 2026, making the 0.088-inch Millipede88 the first super-bore catheter indicated for standalone direct aspiration in stroke. The Galway company backed the filing with the 180-patient MARRS study and had raised €22M from existing investors a year earlier.
FDA approved Perimeter Medical Imaging AI's Claire OCT System (P250008) on March 3, 2026, for margin assessment of excised lumpectomy tissue during surgery. The Toronto company, listed on the TSX Venture Exchange, reported 88.1% margin accuracy in a trial funded by a $7.4M CPRIT grant.
FDA approved the Synergy Disc on February 26, 2026 under P250028, 210 days after Synergy Spine Solutions filed the PMA. The Louisville, Colorado company's single-level cervical disc beat ACDF fusion on composite clinical success, 87.1% with p<0.0001, in its IDE trial.
FDA approved the Allurion Gastric Balloon System on February 20, 2026 under P250023. The label covers adults 22 to 65 with a BMI of 30 to 40. In the 550-patient AUDACITY trial the responder co-primary endpoint passed while the comparative endpoint missed its 3% superiority margin.
FDA approved Empirical Spine's LimiFlex Dynamic Sagittal Tether on February 12, 2026 under P220031, a PMA received December 19, 2022. The motion-preserving alternative to fusion for Grade I degenerative spondylolisthesis held Breakthrough designation since April 2021 and was tested against 160 TLIF patients.
FDA approved Neurolief's ProlivRx headset on December 31, 2025 under P250010. The label is adjunctive at-home treatment for major depressive disorder in adults who failed at least one antidepressant. The approval trips a milestone in BrainsWay's August 2025 deal, which committed up to $6 million more on FDA approval.
FDA granted HAI Solutions' De Novo request for the QIKCAP System on December 23, 2025. The grant creates a new Class II regulation, 21 CFR 880.6512, for UVC microbial reduction devices for luer-activated valves. The Carlsbad startup announced DEN250004 on December 30 after a 327-day review.
FDA cleared UpDoc on December 23, 2025 under K253281, 85 days after the Mountain View startup filed. The prescription software takes glucose, meal and symptom data through a voice or chat agent and issues insulin instructions from prescriber-set parameters. The 510(k) summary reports no clinical testing.
FDA approved Zenflow's Spring Implant and Delivery System for BPH on December 11, 2025 under P250007, a 275-day review. In the BREEZE trial of more than 200 men, 60% of treated patients were responders at one year versus 33% on sham.
FDA approved Flow Neuroscience's FL-100 tDCS headset on December 8, 2025 under P230024. It is the first prescription at-home brain stimulation device for major depressive disorder in the US. The Malmö startup filed in August 2023 and backed the PMA with a 174-patient sham-controlled trial.
FDA approved ProVerum's ProVee System for BPH on December 9, 2025 under P250011, a 251-day review. The Dublin company closed an $80 million Series B led by MVM Partners on August 25 to fund the US launch.
FDA approved Cleveland Diagnostics' IsoPSA blood test on November 28, 2025 under P200048, a PMA the agency received on December 28, 2020. The test is indicated for men 50 and older with PSA between 4.0 and 10.0 ng/mL who are being considered for biopsy.
FDA granted Pulsenmore's De Novo request for the Pulsenmore ES home prenatal ultrasound on October 31, 2025, creating a new device type under DEN240074. The Israeli company's shares rose 33% on the Tel Aviv Stock Exchange when it announced the grant on November 3.
FDA cleared Bunkerhill MAC on October 3, 2025 under K250662. It is the first AI algorithm cleared to detect and quantify mitral annular calcification on routine non-gated chest CT. It is the San Francisco company's seventh 510(k) since April 2023 and its second in 14 days.
FDA cleared Jupiter Endovascular's Vertex catheter on September 12, 2025 under K252027, 74 days after the June 30 submission. The clearance covers insertion of endovascular devices; the pulmonary embolism claim still depends on the SPIRARE II trial.
FDA approved Womed's Leaf resorbable adhesion barrier on September 9, 2025 under P240015, the first US device for moderate to severe intrauterine adhesions. The Montpellier startup filed in May 2024 and backed the PMA with a 160-patient trial.
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