Medical Devices

ABBOTT PARK, Ill. – November 02, 2026 -- Abbott's investigational Amulet 360 left atrial appendage (LAA) occluder achieved complete closure (zero mm leak) in 96.3% of patients assessed by transesophageal echocardiography (TEE) at one year in the VERITAS pivotal study.

Abbott (NYSE: ABT) presented the data in a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego on Nov. 1, 2026. The results were published simultaneously in JACC: Cardiovascular Interventions. The device targets people with non-valvular atrial fibrillation (AFib) who may need an alternative to long-term blood-thinning medication.

VERITAS one-year data show stroke-free rates above 98%

More than 98% of patients remained free from ischemic stroke or systemic embolism through one year. More than 98% were free from cardiovascular-related mortality.

BRANFORD, CT – October 29, 2026 -- Urologic Design closed an oversubscribed $1.2 million pre-seed round to move its patented urinary incontinence device toward a first-in-human study.

Angel Investor Forum leads a syndicate of regional and university-linked backers

Angel Investor Forum, described as Connecticut's primary angel group, led the equity round. HBS Alumni Angels of Boston, Haven Founders Fund, Connecticut Innovations and Yale Angels joined, along with several individual investors.

Matthew Stannard, Life Sciences Lead at Angel Investor Forum, said the firm backed the company because it bridges the gap between absorbent products and surgery. He called first-in-human testing "an important step on the path to commercialization."

Burlington – October 29, 2026 -- The U.S. Food and Drug Administration has approved an expanded indication for Instylla's Embrace Hydrogel Embolic System (HES), covering embolization of peripheral arterial bleeds in vessels of 6 mm or less. Embrace HES is now the first and only liquid embolic approved for both peripheral arterial bleeds and hypervascular tumors, according to the privately held company. The product is commercially available in the U.S.

HALT trial met both primary endpoints in 130 patients

The approval rests on the HALT study, a prospective, multicenter, single-arm trial that enrolled 130 patients with peripheral arterial bleeds at 22 U.S. sites. Embrace HES delivered 100% freedom from major adverse events and 90.0% clinical success, defined as no rebleeding from the target lesion, through 30 days. Both were prespecified primary endpoints.

Santa Clarita – October 29, 2026 -- SetPoint Medical has treated its first patient in Boston with the SetPoint System, extending the only FDA-approved neuroimmune modulation therapy for rheumatoid arthritis (RA) to adults across New England.

Beth Israel Deaconess surgeon performs first Boston implant

Joshua P. Aronson, M.D., a functional neurosurgeon at Beth Israel Deaconess Medical Center (BIDMC), performed the procedure. He described it as an outpatient intervention that opens a different treatment pathway for RA patients.

The system includes a small implantable neurostimulator that delivers targeted stimulation to the left vagus nerve. The stimulation activates the body's innate anti-inflammatory pathways to regulate the immune activity associated with RA.

VADUZ – October 29, 2026 -- Implantica AG has begun training its first U.S. surgeon on the RefluxStop anti-reflux implant, with the first U.S. procedures already scheduled at the University of Southern California (USC) after FDA approval in August 2026.

USC professor observes live RefluxStop procedures in Mainz

Dr. John C. Lipham, Professor of Surgery at USC, observed RefluxStop procedures performed by Dr. Moustafa Elshafei at Marienhaus Klinikum Mainz, Germany, on Monday, October 26. The observation is part of the training requirements for U.S. surgeons.

Lipham said his waiting list has continued to grow since the FDA approval and that he is eager to return to Los Angeles and begin treating patients.

Menlo Park – October 13, 2026 -- Endovascular Engineering, Inc. (E2) has received U.S. FDA 510(k) clearance for both the Hēlo Thrombectomy System and Hēlo Return, a blood return system the company describes as the first cleared for use with continuous vacuum aspiration.

FDA clears two devices for pulmonary embolism treatment

The Hēlo platform is built for treating pulmonary embolism (PE). The FDA's decision followed its review of clinical data from the ENGULF IDE study, which demonstrated safety and efficacy of the Hēlo Thrombectomy System. E2 says it is now accelerating plans to bring the platform to a broad range of physicians and patients.

Fargo – October 13, 2026 -- Sharp Biomedical, a medical device company building manual procedures for outpatient pain clinics, has closed its pre-seed funding round, led by North Dakota venture fund gener8tor 1889 with participation from several physician angel investors. The announcement did not disclose the round size.

Capital covers the full development and testing pathway for a first implant system

Sharp Biomedical says the proceeds fully fund development and testing of its first purpose-built toolset and implant system. The system is designed to fit the workflow of outpatient pain clinics and targets early-to-mid-stage chronic pain patients.

Toronto – October 12, 2026 -- Men treated with whole-gland TULSA Procedure showed no median change in penile length at one month, compared with a median 0.65 cm reduction after robotic radical prostatectomy (RP), according to new data from the Level 1 CAPTAIN randomized controlled trial, Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) announced.

Mixed-effects model shows 0.42 cm between-arm difference

The between-arm difference in change in penile length, estimated from a mixed-effects model, was 0.42 cm (p<0.001), which Profound describes as statistically significant. Xiaosong Meng, MD, PhD, Assistant Professor in the Department of Urology at UT Southwestern Medical Center, presented the results at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, Florida.

Toronto – October 12, 2026 -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) has appointed Richard Fabian, a medical imaging executive with more than 29 years of experience, as President, effective immediately, as the company moves its previous President into a newly created Chief Technology Officer role.

Fabian succeeds Mathieu Burtnyk, who becomes Chief Technology Officer

Fabian replaces Mathieu Burtnyk, PhD, who shifts to the newly created CTO position. Burtnyk invented the patented closed-loop temperature feedback control algorithm used by the TULSA-PRO platform. He has also led the scientific design and execution of all of the company's clinical studies for the technology, including the ongoing Level 1 post-market CAPTAIN randomized controlled trial.

Toronto – October 12, 2026 -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) will hold one-on-one investor meetings at the Lake Street Capital Markets "BIG10" Conference in New York City on September 10, 2026.

The event runs in a one-on-one meeting format only. Profound will not offer a webcast, so investors who want access to management must attend the meetings in person.

Profound Medical sells interventional MRI therapies built around two platforms

The commercial-stage medical device company develops and markets interventional MRI (iMRI) procedures. Its flagship platform, TULSA-PRO, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure to see, ablate and confirm therapy in real time. The approach covers treatment from whole-gland to subtotal, hemi, multifocal and focal ablation.