Colospan announced today that it won FDA investigational device exemption for its CG-100 temporary intraluminal bypass device for gastrointestinal resection procedures. Following the IDE win, Israel-based Colospan plans to launch its pivotal study for the CG-100 device, which is designed to reduce diverting stoma rates in patients undergoing those resection procedures. In comparison to diverting […]
Virtual Incision raises $20m for MIRA surgical robot
Virtual Incision announced today that it raised $20 million in a Series B financing round for its MIRA (miniaturized in vivo robotic assistant) surgical robotic platform. The company also filed for an FDA investigational device exemption for the MIRA platform so it can initiate a clinical study in support of its regulatory pathway to approval. […]
Polyganics’ Liqoseal sealant patch wins CE mark approval
Polyganics announced that it is initiating the European launch of its Liqoseal dural sealant patch after it won CE Mark approval. The Groningen, The Netherlands–based company’s Liqoseal dural sealant patch is designed to reduce cerebrospinal fluid (CSF) leakage following elective cranial surgery. Liqoseal’s European approval follows the Encase I clinical trial, which revealed an absence […]
3Derm lands FDA breakthrough device designations for autonomous skin cancer AI
3Derm Systems announced that it won two FDA breakthrough device designations for its 3DermSpot autonomous artificial intelligence imaging system for detecting skin cancer. The 3DermSpot is an algorithm designed to use AI and highly standardized skin images to autonomously detect melanoma, squamous cell carcinoma and basal cell carcinoma. Autonomous AI has the potential to provide […]
Certain Mazor X robots could unexpectedly detach from OR table, Medtronic warns
This article has been updated with comments from Medtronic. Medtronic (NYSE:MDT) said today that some of its Mazor X surgical robotic systems could detach and fall onto the OR table, potentially injuring a patient. The problem affects Mazor X systems with posititioner Type II, the company said in an urgent field safety notice issued in the […]
Medicrea lands 7 new patents
Medicrea (EPA:ALMED) announced that the U.S. Patent Office recently issued the artificial intelligence spinal surgery developer seven new patents related to its UNiD adaptive spine intelligence (ASI) technology platform. The UNiD ASI is designed to use artificial intelligence to enhance clinical and surgical workflow, increase reproducibility, improve surgical outcomes and expand the potential for surgeons. The […]
Abbott LVAD wins FDA approval for implantation without open heart surgery
Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral thoracotomy — a less invasive approach than open-heart surgery. The approval comes about a year and a half after Medtronic (NYSE:MDT) won a similar approval for the competing HeartWare HVAD pump. Lateral thoracotomy involves a surgeon making an incision between a person’s […]
Teleflex’s UroLift wins new FDA designation
Teleflex (NYSE:TFX) said today that the FDA has granted the company an expanded indication for the use of its UroLift system to treat larger prostates, between 80cc and100cc. UroLift is a minimally invasive, in-office treatment designed to provide rapid relief and recovery from the symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate. Symptoms may […]
BioNess wins CE Mark for StimRouter neuromod system
BioNess announced today that it won CE Mark approval for its StimRouter neuromodulation system indicated for the treatment of fecal incontinence. The StimRouter system previously won approval for treating chronic pain and overactive bladder. The small implantable system targets the tibial nerve near the ankle. Patients undergoing the StimRouter implant procedure receive one incision as […]
PhotoniCare wins FDA nod for imaging tech to spot ear infections
PhotoniCare announced today that it won FDA 510(k) clearance for its TOMi Scope for non-invasive imaging of the middle ear to spot ear infections and more. The TOMi Scope is designed to determine the presence or absence of fluid in the middle ear, as well as to characterize the fluid type, by using optical coherence […]
Avita Medical wins FDA investigational device exemption approval for Recell System for vitiligo
Avita Medical (ASX:AVH) said it received FDA investigational device exemption approval for a study to evaluate its Recell System for vitiligo. The company plans to conduct a feasibility study to evaluate the system’s safety and effectiveness for repigmentation of depigmented lesions that are associated with stable vitiligo. “Vitiligo affects approximately 6.5 million people in the U.S., […]
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