Device Pipeline and Approvals

The FDA’s IDE approval allows Presidio to initiate a randomized, controlled trial in the United States and Australia to evaluate the safety and efficacy of its ULF neuromodulation technology

The novel test uses a machine learning algorithm and multiple cardiac protein markers to detect obstructive coronary artery disease through a simple blood draw.

Company eyes FDA clearance for expanding use of real-time navigation technology

Guardant Health's Shield multi-cancer screening test detects multiple cancer types with a single blood draw, promising early diagnosis for various cancers.

Reflow Medical's Spur Stent System gains FDA clearance, offering treatment options for chronic limb-threatening ischemia with its retrievable design.

Company expects to submit to FDA in 2026

Atia Vision's OmniVu lens system promises a breakthrough in cataract surgery with enhanced vision restoration.

Fujirebio Diagnostics’ test, which received 510k clearance Friday, will “assist physicians and patients to obtain an AD diagnosis in early stages of the disease.”

Osteoboost introduces a groundbreaking FDA-cleared device for osteoporosis, offering innovative, non-invasive therapy to enhance bone health and prevent fractures.

Imperative Care enhances stroke treatment with Zoom DuoPort, enabling efficient dual aspiration for faster, more effective thrombectomy procedures.

BrightHeart's FDA-cleared AI platform enhances fetal heart screenings, improving detection of congenital heart defects during ultrasounds with real-time analysis.

The Jewel Patch-WCD offers a discreet solution for patients at risk of cardiac arrest, enhancing safety and daily life integration.

CorWave advances heart failure treatment with a groundbreaking LVAD, showcasing promising preclinical results and paving the way for human trials.

This is the first time an implantable, long-term EEG monitoring device has been authorized for use in the United States.

The company received the designation for its atrioventricular interval modulation therapy, a novel pacemaker-based treatment aimed at reducing blood pressure in patients with uncontrolled hypertension and elevated cardiovascular risk.

Device uses an adaptive algorithm to automatically adjust and correct glucose levels every five minutes around the clock.

Adagio Medical Receives FDA Breakthrough Device Designation for its Cryoablation System that targets VT

The newly cleared system uses advanced identification and antimicrobial susceptibility testing algorithms to support the interpretation of complex microbiological data.

Device can now be used in patients with symptomatic moderate-to-severe or severe mitral regurgitation who are not candidates for surgery or transcatheter edge-to-edge repair therapy.

RSP Systems achieves major milestone in non-invasive glucose monitoring technology

Clearance is the first AI platform for real-time surgical measurements, marking major leap in operating room innovation

The company also expects to submit its application for 510(k) clearance for its OneRF Trigeminal Nerve Ablation System in May, sooner than expected.

Inovalon’s Safety Management solution now on PointClickCare Marketplace

Test is designed for females regardless of symptoms and gives results in about 30 minutes

Media report highlights how FDA workloads have increased, and delays for new technology approvals will likely suffer

FDA approves Dawes-Redman CTG analysis for U.S. use, enhancing fetal monitoring

AdvaMed, Senate Democrats warn of regulatory slowdowns and public health threats following mass layoffs at the FDA.

Triage solution is built on existing AI engine

Autonomous solution doesn’t require dilation in vast majority of cases