A total of $15 million in proceeds has been raised by Bellaire, Texas-based OrthoAccel Technologies in a second round of Series C funding. The company, which secured $5 million in a Series C funding round last year, also announced the departure of its president and CEO, Michael Lowe, and the appointment of Kelly Enos, its chief financial officer and vice president of finance and administration, as interim CEO.
A round of Series A financing led by Whitecap Venture Partners has brought in $6 million for Ottawa, Ontario-based mobile medical device firm Clearwater Clinical, bringing its total funding to $9.5 million. The company intends to use the proceeds to scale the business surrounding its tablet-based audiometer Shoebox, expand its footprint in Europe and North America and advance its service offerings.
An agreement has been reached by Atlanta-based Medovex and Italian spine surgery equipment supplier AlfaMed to distribute Medovex's DenerveX System in Italy. The deal calls for sales, marketing and distribution services from AlfaMed to support the launch of the system, which is designed to provide relief of facet joint-associated pain.
A GlobalData report predicts the worldwide spinal fusion market will hit $9 billion by 2023 with a 3.4% compound annual growth rate due to an increase in technological advancements and the growing incidence of degenerative spinal conditions. Europe is expected to see market growth throughout the period due to a lower number of barriers to performing the surgery.
A PricewaterhouseCoopers white paper showed the use of ResMed's myAir app for tracking continuous positive airway pressure therapy compliance led to improved treatment adherence by patients. Another device called EarlySense Live, a contact-free sensor developed by EarlySense for detecting sleep cycles and vital signs, demonstrated a 92.5% agreement with the gold standard of sleep studies, polysomnography, according to a paper in the Journal of Clinical Sleep Medicine.
A next-generation hybrid operating room system that provides a 3D augmented-reality view of the external and internal anatomy of a patient using a combination of 3D X-ray and optical imaging has been unveiled by Royal Phillips for use in cranial, spine and trauma surgery. The surgical navigation system demonstrated improved spinal screw placement in traditional open spinal surgery, according to a preclinical study in the journal Spine.
The Allen Advance Table Lateral System has been introduced by Hill-Rom Surgical Solutions as a complement to its Allen Advance Table for use in complex surgical procedures. The system, which is expected to be officially released Monday, enables the patient to be rotated 90 degrees from a lateral to a prone position using the Allen Advance Table.
A bipartisan bill that would repeal the medical device tax through an amendment to the Internal Revenue Code was reintroduced Thursday in the Senate. AdvaMed President and CEO Scott Whitaker lauded the move, saying "companies need the certainty of permanent repeal to support long-term planning that will allow for future patient innovations and job growth" and sustain the benefits brought by the suspension of the tax.
A final guidance has been released by the FDA outlining the factors it weighs when making evaluations of risks and benefits for investigational device exemptions. The document, which covers original IDE applications, IDE supplements and IDE amendments, clarifies that disapproval of an IDE will not be based on a study plan's failure to support marketing approval or clearance but noted that "well-designed studies are more likely to produce important knowledge about a device or disease."
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