Based on the most recent data from March, it appears that the FDA is on pace to grant expedited review to over 250 medical devices in 2023, a significant increase from just 166 last year.
With the FDA granting larger numbers of breakthrough device designations, it may prove to be a worthwhile and cost-effective option for medical device companies that are seeking to reach the market faster with a device that meets the qualifications for the program.
And the opportunity here is massive considering that the medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5% a year to reach nearly
Although investors may find it hard to sift through the multitude of medical device stocks chasing breakthrough designations, here are some well established players that look well placed to capitalize on this multi-billion market.
Vascular Disease: The company has two devices here. An innovative clot-retrieving device, PREVA, which is the first and only protective blood clot retriever using a distal basket; and a deep vein thrombosis solution for leg pain post surgery called Venowave.
Venowave is a compact and lightweight Deep Vein Thrombosis (DVT) prevention device specifically designed for use in healthcare settings and at home. The device uses a continuous wave motion to increase blood flow in the veins. The increased blood circulation helps prevent venous stasis, which is a major contributor to clot formation.
According to recent research, more people die annually from blood clotting complications than from breast cancer, HIV, and traffic accidents combined. This staggering fact highlights the necessity of Deep Vein Thrombosis (DVT) prevention.
With about 50% of DVTs beginning to form intra-operatively and 75% forming within 48 hours post-operatively, this technology is pioneering an alternative, easy to use, and potentially life-saving treatment for this condition.
"This is a major development for our company and the patients who rely on Venowave. These CPT codes will provide greater clarity and precision in medical billing and streamline the reimbursement process for healthcare providers, patients, and insurers," said
Its lead product candidate is TULSA-PRO which is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities.
On
According to Profound's CEO and Chairman,
The company's flagship product, the Perimeter S-Series OCT uses ultra-high-resolution Optical Coherence Tomography (OCT) to provide high-definition, 3D images of margins in the operating room at 10 times higher resolution than ultrasound and X-ray and 100 times higher than MRI.
Recently, Perimeter announced the first commercial placement of its flagship Perimeter S-Series OCT medical imaging system in the state of
"This latest commercial placement of our flagship Perimeter S-Series OCT, which marks the first in the state of
Its lead product, VMS+, is designed to create an accurate 3D model of the heart from a 2D echocardiogram and allow a physician to obtain cardiac metrics on all four chambers of the heart within minutes. VMS+ achieves this using a proprietary Knowledge Based Reconstruction (KBR) algorithm that leverages a MRI shape catalog and anatomical landmarks from standard 2D echocardiogram images to construct a complete 3D model of the heart.
Last month, the company announced that a VMS+ product had been purchased and fully operationalized in the Deutsches Herzzentrum der Charite (DHZC), German Heart Center, in
President and Chief Executive Officer,
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