fda-510k
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How VYRSA Turned One Tiny Joint Into a $75 Million Bet
VYRSA built a three-product answer to a stubborn source of back pain, won FDA clearance for a stranger kind of implant, and sold to Nevro before its third birthday. The playbook is compact: license hard science, simplify the procedure, and let a bigger sales force carry it.
NDR Medical Technology
NDR Medical Technology is a Singapore-based deep-tech company building AI-empowered interventional robotics for minimally invasive, image-guided surgery. Its Automated Needle Targeting (ANT) platform combines hardware and software to plan and align percutaneous needle placement with roughly ±1mm accuracy using a hospital's existing imaging equipment. Its flagship ANT-X robot received U.S. FDA 510(k) clearance in 2023 as the first automated device to aid kidney access for percutaneous nephrolithotomy, while ANT-C brings AI CT-based lesion targeting to procedures across the lung, liver, kidney and spine.
3NT Medical
3NT Medical is an Israeli medical device company building a family of sterile, single-use endoscopes purpose-built for ear, nose, and throat (ENT) surgeons. Its two FDA-cleared, CE-marked products - the Colibri Micro ENT Scope for otology and the Peregrine Drivable ENT Scope for the sinuses - are designed to reach narrow anatomy that rigid reusable scopes struggle to see, while removing the cross-contamination and reprocessing burden of multi-use devices. Founded in 2012 by brothers Ehud and Eran Bendory and backed by Japanese optics maker Hoya, the company operates from Rosh Ha'ayin, Israel, with U.S. operations in Short Hills, New Jersey.
Interscope, Inc.
Interscope, Inc. is a Northbridge, Massachusetts medical device company that develops the EndoRotor, a flexible, powered endoscopic resection system that dissects, resects, and collects tissue in the gastrointestinal tract without thermal energy. Founded in 2011, the company created the first flexible microdebrider designed for the digestive tract and holds the first and only FDA marketing authorization for Direct Endoscopic Necrosectomy (DEN) in walled-off pancreatic necrosis. Interscope sells to interventional gastroenterologists and hospitals, and distributes the EndoRotor system through a partnership with Micro-Tech Endoscopy.
Pearl Diagnostics, Inc.
Pearl Diagnostics is a Baltimore-based in vitro diagnostics company spun out of Johns Hopkins University that develops non-invasive urine tests to detect life-threatening lung infections. Its proprietary Smart Antibody technology identifies circulating microbial extracellular vesicles, and its lead product, the MycoMEIA Aspergillus Assay, became the first urine-based test to win FDA 510(k) clearance for aiding diagnosis of invasive aspergillosis. The company raised an $11.2M Series A in March 2026 to commercialize in the US and expand across Europe.
Carecubes
Carecubes makes the Carecube, an FDA 510(k)-cleared negative-pressure isolation canopy that turns any standard hospital bed into an airborne-isolation unit in about 20 minutes. Born from a DARPA-funded Ebola-era project at San Francisco research lab Otherlab, the device pulls air through an H14 HEPA filter, holds negative pressure, and lets caregivers reach patients through glove walls - isolating the pathogen instead of the patient. The Arden Hills, Minnesota company closed a $6.5M Series A in March 2026 and has deployed across dozens of communities and health systems.
Vena Vitals
Vena Vitals is an Irvine, California medical-device startup building a soft, skin-worn sticker sensor that continuously measures blood pressure without a cuff or an arterial line. Spun out of UC Irvine biomedical engineering research, its VeriTrack system uses a patented wrinkled-metal capacitive pressure sensor to capture beat-to-beat data with accuracy validated against arterial lines in operating rooms across the country. Founded in 2019 by Ray Liu, Michelle Khine, and Josh Kim and backed by Y Combinator, the company is pursuing FDA clearance to bring continuous, noninvasive blood pressure monitoring first into hospitals and later into homes.
AngioWave Imaging
AngioWave Imaging is a Massachusetts-based medical AI company building post-processing software that sharpens fluoroscopic angiograms in the cardiac catheterization lab. Its FDA 510(k)-cleared AngioWaveNet uses a spatiotemporal, convolutional deep neural network (branded STEP) to reveal blood-vessel detail that is hard to see on the raw angiogram, helping interventional cardiologists diagnose and treat coronary artery disease. The software runs on top of any existing fluoroscopy system, requiring no new hardware.