Schmidt Group Updates | August 2026

Here's what's been happening in medtech this summer:

FDA pace is up, but slower per-device. The FDA has authorized more medical devices in the first half of 2026 than in the same period last year, though submissions are taking longer to approve on average. The FDA approved 23 devices via the premarket approval pathway through June, up from last year, while 510(k) clearances are trending up about 2.5% year-over-year with roughly 1,669 granted through June. MedTech Dive

Cardiac tech is a hot spot. Johnson & Johnson got FDA approval for its Dual Energy THERMOCOOL SMARTTOUCH SF Platform, a catheter ablation system that delivers both radiofrequency and pulsed-field energy through a single catheter — notable since pulsed-field ablation is one of the fastest-growing device categories right now. Pulsed-field ablation devices are projected to grow at roughly an 80% compound annual rate through 2028. Todaysmedicaldevelopments

Neurotech and pain/spinal devices. NeuraNova got 510(k) clearance for its STEDI Device, a portable bioimpedance tool that noninvasively measures fluid distribution in the head for neurological assessment, and Saluda Medical received approval for a new spinal cord stimulation paddle lead aimed at neurosurgeons and orthopedic surgeons. Todaysmedicaldevelopments

Broader trend: AI and wearables everywhere. Medical devices are increasingly defined by software rather than just hardware, with the clearest activity in connected wearables, AI-enabled software, neurotechnology, targeted drug delivery, and devices meant for use outside traditional care settings. Industry-wide, AI is showing up in cardiology, neurology, oncology, and radiology — spanning imaging, diagnostics, patient monitoring, infusion systems, and surgical robotics. Xtalks

Other MedTech News:

FDA issues alert in wake of BD recall of faulty needle sets that caused four deaths

UC Davis Engineers Develop Medical Device to Better Protect Babies on Ventilators

KKR nearing deal to buy medical device firm Integer, WSJ reports

Medtronic Loses First Hernia Mesh Trial, Ordered to Pay $88 Million

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SENIOR SALES EXECUTIVE

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Ingredients:

1 tablespoon shortening, or as needed
1 white onion, chopped
1 green bell pepper, chopped
3 cloves garlic, chopped
8 cups water
1 pound dried red beans
1 smoked ham hock
1 pound smoked sausage, cut into bite-sized pieces

2 stalks celery, chopped
2 bay leaves
1 tablespoon cajun seasoning
½ teaspoon dried thyme
½ teaspoon dried sage
1 dash hot pepper sauce, or to taste
3 cups cooked white rice

Directions:

Gather the ingredients.
Melt shortening in a skillet over medium heat. Cook and stir onion, bell pepper, and garlic in hot shortening until tender, 5 to 7 minutes.
Combine water, red beans, and ham hock in a large pot; bring to a boil. Stir onion mixture into the pot; add smoked sausage and celery. Return to a boil. Stir bay leaves, Creole seasoning, thyme, and sage into boiling water. Reduce heat to low, cover the pot, and simmer until beans are tender, about 5 hours.
Remove and discard ham hock and bay leaves; stir in hot pepper sauce and serve over white rice.

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