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Hubly Surgical Receives 510k Clearance from FDA to Market Innovative Cranial Access Drill for Neurosurgical Safety in the ICU

Wednesday, May 10, 2023

Hubly Surgical announced today that they received 510k clearance from the FDA to market the Hubly Drill, an innovative medical technology developed with the goal of making burr hole procedures safer and more efficient in any setting, including outside of the operating room.

A burr hole procedure is the prerequisite brain surgery for any time a physician needs to access the brain. This is done for patients with traumatic brain injury, hydrocephalus, ruptured aneurysm, stroke, subdural hematoma, epilepsy, Parkinson's, and brain cancer and tumors. These procedures are frequently performed outside of the operating room in emergencies, yet the current bedside procedure relies on an inaccurate device, deficient in safety and efficiency features.

"Burr holes are one of the most common neurosurgical procedures we perform," said Dr. Matthew Potts, a Cerebrovascular Neurosurgeon and Assistant Professor at Northwestern. "And at the bedside, they are often done using a cumbersome hand-cranked drill. I know first-hand how antiquated this solution is and how dangerous this procedure can be. I'm excited that Hubly has developed an improved intracranial drill for burr-hole placement."

The Hubly Drill aims to mitigate the challenges of bedside cranial access by being the first and only cordless single-use cranial drill with advanced features for safety and efficiency in any setting. "Essentially we are bringing the precision of the operating room, which physicians are accustomed to, to the bedside," said Founder/CEO Casey Grage.

The technology features novel innovations for safety and efficiency, including SMART Auto-Stop with a proprietary drill bit designed to reduce over-plunge (a common problem with the current standard of care). There is also a first-of-its-kind LED Force Indicator that changes color with force, increasing user control. 

Grage added, "We believe the facilities that add the Hubly Drill into their workflow will recognize significant value by reducing operating room dependence and increasing access at the bedside, thus lowering hospital costs." 

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