Biotech
A published application from Stryker Corporation describes feeding intraoperative fluorescence images into the generator of a trained adversarial model to produce a simulated white-light photograph of how the tissue will look later. The first operative claim is a four-step image-translation method.
Biotech
A published Edwards Lifesciences application claims implantation methods in which the whole valve frame lands in the gap between the aortic annulus and the sinotubular junction. The engineering hinges on one measurement taken before the valve is chosen.
Biotech
A published application describes a conjugate in which one or more GLP-1 receptor agonist peptides are covalently linked to an antibody that binds GDF8. The engineering content sits in the conjugation process — an enzyme-installed handle, Click or Diels-Alder coupling, and attachment at a single named residue.
Neurotechnology
An issued university patent threads a microelectrode catheter through the subarachnoid space from a lumbar puncture, and powers the implant wirelessly with a magnetoelectric film driven at resonance.
Medical Devices
An issued patent detects when a device has rotated inside its surgical pocket by noticing that its accelerometer reports a lying-down posture while the patient is verifiably standing.
Medical Devices
A newly issued patent lets an implanted device watch its energy harvester with onboard accelerometers, comparing how much the harvester mass moves against how much charge it returns.
Biotech
A patent application published July 2 describes a planar end effector for pulsed field ablation of atrial fibrillation — elongated ablation electrodes paired with isolated diagnostic, contact, and reference electrodes on one flexing paddle. It was one of nine Biosense Webster electrophysiology filings in the same drop.
Biotech
A patent issued June 30 describes building a computational fluid-dynamics model of a patient's vessel from imaging and flow data, then flagging target and avoidance regions for a neuromodulation catheter. It issued in a cluster of Medtronic device grants spanning imaging, leads, and bioelectric sensing.
Diagnostics
A newly published Kephera Diagnostics application describes a benchtop instrument and reagent kit that pull a target molecule onto a magnetic bead inside a thin capillary and read a glowing europium tag in seconds. It is a compact, ground-level look at how a sandwich immunoassay gets engineered into a self-contained device.
Biotech
A CLIA waiver lets a lab run designated simple, low-risk tests under a certificate of waiver. The criteria, set in federal regulation, turn on simplicity and a negligible chance of error.
Biotech
A UDI is a standardized identifier the FDA requires on the label of medical devices, splitting into a device identifier and a production identifier, and feeding a public database of millions of records.
Biotech
An IVD is a test that examines specimens taken from the body, reagents, instruments, and systems used to diagnose disease. The FDA regulates IVDs as medical devices, with their own labeling rules.
Biotech
When a device is too new to have a predicate but too low-risk for premarket approval, the De Novo pathway creates a brand-new Class I or II classification, and often a future predicate.
Biotech
Every U.S. medical device is sorted into one of three regulatory classes based on the controls needed to assure its safety. The class determines the controls, the submission, and the pathway.
Biotech
A predicate is the legally marketed device a new device is compared against to claim substantial equivalence. The FDA's regulation defines it precisely, and the definition shapes the entire 510(k).
Biotech
Both are FDA premarket pathways for medical devices, but they answer different questions. One asks whether a device is equivalent to an existing product; the other asks whether the device is independently safe and effective.
Biotech
A 510(k) is a premarket notification a device maker files to show its product is substantially equivalent to one already on the market. Here is what the regulation requires and how the pathway works.
Biotech
An SEC filing dated June 18, 2026 discloses that Sonoma Pharmaceuticals (SNOA) has filed a supplement increasing the size of its at-the-market common-stock program and reports how much it has sold so far.
Biotech
Amgen is comparing its T-cell engager xaluritamig combined with abiraterone against investigator's choice of therapy in 750 men with chemotherapy-naive metastatic castration-resistant prostate cancer, measuring overall survival, per a ClinicalTrials.gov record updated June 18, 2026.
Biotech
Eli Lilly's once-daily oral GLP-1 candidate orforglipron is being studied against placebo in 150 adolescents aged 12 to 17, with a 72-week BMI endpoint, per a ClinicalTrials.gov record updated June 18, 2026.
Medical Devices
A newly published Intuitive Surgical application describes training machine-learning models to recognize the phases of a procedure by fusing surgical video with the robot's own sensor data. It is a window into how a robotic surgery platform is learning to understand what is happening on the table.
Biotech
uniQure says the FDA will accept the 3-year analysis from its Phase I/II study as the primary basis for an accelerated-approval filing of AMT-130 in Huntington's disease, with the BLA targeted for the third quarter of 2026.
Biotech
FDA enforcement record D-0554-2026 shows Spectra Medical Devices recalled single-dose lidocaine injection ampules for lack of assurance of sterility — a defect that carries different stakes for an injectable than for a pill.
Biotech
An FDA enforcement record (D-0558-2026) shows Guardian Drug Co. recalled Haleon's Tums antacid chewables over small metallic particles — part of a multi-brand calcium-carbonate recall flagged the same day.
