Recent insights from March spotlight a remarkable trend: the FDA is on track to approve more than 250 medical devices with expedited review in 2023, marking a notable upsurge from the 166 approvals in the previous year.

This uptick in breakthrough device designations by the FDA presents a golden window for medical device companies. The potential rewards are significant, especially as the global medical device sector is projected to surge by over 5% annually, with sales forecasts hinting at an approximate worth of $800 billion by 2030.

Given the plethora of medical device stocks competing for breakthrough recognitions, discerning investors might be overwhelmed. Yet, a few prominent players stand out in this burgeoning market.


A frontrunner in developing and collaborating on state-of-the-art, proprietary medical devices and diagnostics. Their portfolio includes:

Respiratory Health: Highlighted by the Digital Cough Test (DCT) app, it leverages AI to detect respiratory diseases, boasting an impressive accuracy rate of over 94%. Currently, it’s navigating the FDA clearance route for Remote Therapeutic Monitoring and patient reimbursement.

Consumer Health: Comprises devices like the Benepod for pain relief, InterceptCS for cold sore prevention, and TherOZap for insect bites and stings relief.

Vascular Disease: Introduces the PREVA clot-retrieving device and the Venowave for Deep Vein Thrombosis (DVT) prevention, designed to increase venous blood flow, combating clot formation. Notably, Venowave’s recent Medicare and Medicaid reimbursement slots between $725-$1050 per patient, signaling a breakthrough for Therma Bright.

Profound Medical Corp. (NASDAQ:PROF) (TSX:PRN)

A trailblazer in non-invasive therapies for tissue ablation. Their flagship, TULSA-PRO, safeguards the urethra and rectum while facilitating surgeon-defined prostate volume ablation. Recently, the AMA introduced three new CPT Category 1 codes specific to TULSA, marking a leap towards wider adoption.

Perimeter Medical Imaging AI (TSXV:PINK) (OTC:PYNKF)

Focused on redefining cancer surgery through cutting-edge imaging tools. Their Perimeter S-Series OCT offers unparalleled, real-time, 3D visualizations in surgeries, boasting a resolution exponentially higher than standard methods.

Ventripoint Diagnostics Ltd. (TSXV:VPT) (OTC:VPTDF)

Committed to advanced healthcare solutions, their VMS+ transforms 2D echocardiogram data into 3D heart models in mere minutes. Recent news reveals its operationalization in the renowned German Heart Center, signaling a revolution in pediatric cardiology.

Hamilton Thorne Ltd. (TSXV:HTL) (OTC:HTLZF)

A leader in precision tools for the ART, research, and cell biology spheres. Their latest sales report shows a 15% growth, reaching $16.4 million for the recent quarter.

As the medical diagnostics and devices realm continues to evolve, these players remain at the forefront, offering innovative solutions and unlocking monumental opportunities for stakeholders.

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