Hubly Surgical secures FDA 510k clearance for Hubly Cranial Drill

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Medical device company Hubly Surgical has received 510k clearance from the US Food and Drug Administration for Hubly Drill, a cranial access drill.

Claimed to be the first and only cordless single-use cranial drill, Hubly Drill has been designed for making burr hole procedures safer and more efficient in any setting, including outside the operating room.

Hubly Drill aims to reduce the challenges of bedside cranial access.

It features SMART Auto-Stop and a proprietary drill bit that has been designed for reducing the over-plunge, which is said to be a common problem with the existing standard of care.

The device is also claimed to include a first-of-its-kind LED Force Indicator that alters colour with force and helps in increasing user control.

Hubly Surgical founder and CEO Casey Grage said: “Essentially we are bringing the precision of the operating room, which physicians are accustomed to, to the bedside.

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

The company stated that a burr hole procedure is the prerequisite for brain surgery and is performed on patients with ruptured aneurysms, subdural hematoma, Parkinson’s, tumours, hydrocephalus, brain cancer, traumatic brain injury, stroke and epilepsy.

They are often performed in emergencies outside of the operating room.

Northwestern assistant professor and cerebrovascular neurosurgeon Dr Matthew Potts said: “Burr holes are one of the most common neurosurgical procedures we perform.

“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.”

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• Source: https://www.medicaldevice-network.com/news/hubly-surgical-fda-510k-drill/