Medical devices have had to deal with a large body of uncertainty where patent protection is concerned, thanks principally to jurisprudence arising out of the Supreme Court. However, Mark Mansour, a regulatory attorney with the D.C. office of Dykema Gossett PLLC, said on a recent webinar that even in the absence of a patent, de novo devices can gain some market exclusivity with smart use of labeling, a practice that can help ensure that the developer can achieve the needed return on investment.

The FDA has granted de novo authorization to Neurolutions Inc. for its Ipsihand upper extremity rehabilitation system. The first-of-its kind device leverages robotics and brain-computer interface (BCI) technology to facilitate muscle training in patients with upper limb weakness or immobility following a stroke.

The FDA authorized marketing of the Portable Neuromodulation Stimulator (Pons) for short-term treatment of gait issues arising from mild to moderate symptoms associated with multiple sclerosis (MS) through its de novo pathway. Helius Medical Inc., a subsidiary of Helius Medical Technologies Inc., makes the non-implantable neuromuscular tongue stimulator.

The FDA has granted de novo authorization to Fifth Eye Inc. for its Analytic for Hemodynamic Instability (AHI), a machine learning (ML)-based, real-time indicator of patient deterioration. Commercialization of the software device, which continuously monitors patients with an electrocardiogram (ECG) for signs of deterioration, got underway on March 1.

Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions.

The U.S. FDA granted de novo authorization for Signifier Medical Technologies LLC’s ExciteOSA, the first treatment for mild obstructive sleep apnea and snoring designed for daytime use. Used for 20 minutes a day, the device improves the function of the tongue muscle to prevent airway obstruction while sleeping. ExciteOSA, previously called Snoozeal, already has a CE mark.

Helix Opco LLC, a company specializing in population genomics, has received de novo marketing authorization from the U.S. FDA for its whole exome sequencing platform, which covers roughly 20,000 genes. The San Mateo, Calif.-based company also picked up 510(k) clearance from the FDA for the first test to run on the Helix Laboratory Platform, a genetic health risk application for late-onset Alzheimer’s disease. That test has been cleared for over-the-counter use in conjunction with the Helix Laboratory Platform.

The U.S. FDA granted de novo marketing authorization to Interscope Inc.’s Endorotor system for direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis, giving the specialty device a cutting edge over more generic tools often used for the challenging procedure. Endorotor received a CE mark for this indication in 2018 and also has FDA 510(k) clearance for post-endoscopic mucosal resection tissue persistence with a scarred base and for removal of endobronchial tumors and granulation tissue.

Miach Orthopaedics Inc. got a leg up on competitors with the U.S. FDA's de novo approval of its Bridge-Enhanced ACL Repair (BEAR) implant. The company achieved a long-term goal in orthopedics, developing a graft-free system that enables the anterior cruciate ligament (ACL) to repair itself. The device represents the first new treatment for ACL tears in three decades.

The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.