Endologix Receives FDA Approval of the DETOUR™ System to Treat Long Complex Superficial Femoropopliteal Lesions in Patients with PAD

Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). Over 8.5 million Americans are affected by PAD.…

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THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System

THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT based three-dimensional surgical plan,…

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Paradromics Raises $33 Million in Funding, Achieves Breakthrough Medical Device Designation from FDA

Paradromics Inc., the leading developer of high data-rate brain-computer interfaces (BCI), today announced a $33 million Series A funding round led by Prime Movers Lab. Additional investors include Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity. The new funding will help Paradromics launch its first-in-human clinical trial for the Connexus® Direct Data Interface (DDI). In addition…

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Novarad’s VisAR Receives FDA Clearance for Augmented Reality Surgical Navigation in Spinal Surgery in Indonesia

Novarad’s VisAR, a surgical navigation system that uses augmented reality, has received clearance from Indonesia’s FDA for intraoperative use in stereotactic spinal surgery. VisAR is accurate for both open and minimally invasive surgery (MISS). This cutting-edge technology enables surgeons to transform a patient’s imaging data into a 3D hologram, which can be projected onto the patient’s body with…

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Virtuoso Surgical Unveils Design of Groundbreaking Robotic Surgery System

Nashville-based medical device company Virtuoso Surgical, Inc. has unveiled its revolutionary robotic surgery system. Virtuoso’s patented technology reimagines endoscopic surgery in scale, function and cost. “Virtuoso gives surgeons their hands back, equipping them to lift tissue, apply tension and maintain traction – in tight spaces within the body,” said S. Duke Herrell, III, MD, FACS, CEO, Co-Founder and Chief Medical Officer…

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First Light Field-Enabled Spine Surgery Navigation Platform, Proprio Paradigm™, Receives FDA Clearance

Proprio, a Seattle-based medical technology company, today announced its surgical navigation platform, Paradigm, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Paradigm utilizes an advanced approach to replace traditional surgical navigation technologies that pull attention away from the patient and disrupt workflows in the process. Proprio’s Paradigm platform is the first to…

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Advamedica Inc announces FDA clearance for Ax-Surgi Surgical Hemostat

Advamedica Inc., a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. With this, Ax-Surgi has become first and only chitosan based hemostat cleared for controlling severe surgical bleeding. Ax-Surgi is based on novel biopolymer platform and controls bleeding through its bioadhesive…

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Asensus Surgical Receives FDA 510(k) Clearance For Pediatric Indication for Senhance Surgical System

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™ (PGS), announced that it has received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance® System. The Senhance System…

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Aquablation Therapy is the first surgical robotics system to receive a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence

PROCEPT® BioRobotics Corporation today announced Aquablation Therapy received a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence (NICE), for benign prostate hyperplasia (BPH) in the United Kingdom. NICE has recognized Aquablation Therapy is as effective as transurethral resection of the prostate (TURP) for the removal of prostate tissue for men with BPH. A panel of…

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Lumendi Receives 510(k) Clearance for Two New Devices

Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new, more cost-effective design, based on the long-standing success of the DiLumen EZ-Glide platform, has been modified and streamlined. “The…

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