surgical intervention News
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FDA has granted the company a Breakthrough Device Designation for its MIScoli™ system
Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in young adolescents. The FDA Breakthrough Device Program is intended to help patients receive more timely access to ...
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Amsel Medical Announces Appointment of Jeff Willis as Senior Director of Engineering
Amsel Medical Corp. today announced the appointment of Jeff Willis as Senior Director of Engineering to help drive the current product commercialization phase and implement the company’s strategy to address the demand for minimally invasive, simple and secure occlusion. “Jeff is an exceptionally focused engineer and executor,” said Amsel Medical CEO David Doster. “He ...
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Sight Sciences Launches “Don’t Wait for Too Late” Awareness Campaign for Glaucoma
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced the launch of its “Don’t Wait for Too Late” educational campaign designed to raise awareness among the optometric community of minimally invasive glaucoma surgery (MIGS) as an ...
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Amsel Medical Announces Appointment of Robert M. Rossell as Chief Commercial Officer
Amsel Medical Corp. today announced the appointment of Robert M. Rossell as Chief Commercial Officer to drive the current commercial phase and implement the company’s strategy to address the demand for minimally invasive, simple and secure occlusion. “I’ve worked with Rob over many years. He brings a great depth of experience, commercial expertise and a track record of ...
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Amsel Medical Announces $1.5 million AFWERX TACFI Grant Award
Amsel Medical Corporation today announced receipt of award and signing of a contract for a non-dilutive AFWERX Tactical Funding Increase (TACFI) of $1.5 million augmenting its original $1M Phase II SBIR Grant. This effort is sponsored by the Air Force Research Laboratory and will enable Amsel Medical to bridge its Phase II efforts towards Phase III commercial scaling. It facilitates the delivery ...
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Procyrion Named Most Innovative Heart Pump Technology In 2018 Global Healthcare and Pharmaceutical Awards
Houston medical device developer Procyrion Inc. today announced they have won the Most Innovative Heart Pump Technology award in the 2018 Global Healthcare and Pharmaceutical Awards for their device, Aortix™, a catheter-deployed circulatory support device designed initially to address cardiorenal syndrome in heart failure patients. The award celebrates the contributions made by ...
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Amsel Medical Announces Expanded Medical Advisor Group
Amsel Medical Corp. today announced the expansion of its medical advisory team as the company advances the current product commercialization phase to address the demand for minimally invasive, simple and secure occlusion. Joining the advisory team are - Col. John Dorsch, DO, USAF, Retired; prior wing surgeon, physician, and medical officer for the 24th Special Operations Wing (Air Force ...
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Amsel Medical Announces Director of Clinical and Medical Affairs
Amsel Medical Corp. today announced the appointment of Lowell S. Kabnick as a consultant acting as Director of Clinical and Medical Affairs, as the company advances the current product commercialization phase to address the demand for minimally invasive, simple and secure occlusion. In addition to serving as the Chancellor of the Vein & Lymphatic University, Dr. Kabnick is the previous ...
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SafeHeal obtains CE-mark for Colovac, its novel endoluminal bypass sheath
Paris, France, April 3, 2019 – SafeHeal, a leading innovator in the field of digestive surgery, announces today that its unique Colovac bypass sheath has received the CE-mark. Colovac is a unique endoluminal bypass sheath placed in the colon following colorectal resection. It suppresses the contact of fecal content with the colorectal anastomotic site in order to significantly improve ...
By SafeHeal
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Checkpoint Surgical Enrolls First Patient in Nerve Regeneration Clinical Study
Checkpoint Surgical, Inc., the leader in intraoperative nerve repair stimulation technology, today announced it has enrolled the first patient in its multi-center clinical study of the company’s breakthrough nerve regeneration technology. The patient was enrolled at The Ohio State University, one of four sites actively enrolling patients in the double-blind, randomized clinical trial. Other ...
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The future of rehabilitation
Congratulations to the ONWARD team for the incredible progress they are making in the field of neuroengineering! In recent days, numerous media have reported the news of a great advance for science, and especially for all those people with spinal cord injury and their medical and caregiver teams. The ONWARD team has developed an epidural electrical stimulation system using electrodes placed ...
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Showcase
RTsafe and Biomedic Medical Group sign exclusive agreement for distribution
RTsafe, a medical technology company focused on improving the safety and accuracy of radiotherapy for cancer and other medical conditions, today announced that Biomedic Medical Group will be the exclusive distributor of RTsafe’s products in China. We are delighted to announce this new collaboration and looking forward to provide our products to the Chinese radiotherapy professionals. ...
By RTsafe
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Procyrion, Inc. Wins Best Overall Medical Device Product in 2018 Medtech Breakthrough Awards
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, today announced that its AortixTM device won the MedTech Breakthrough Award for "Best Overall Medical Device Product." MedTech Breakthrough is an independent organization that recognizes the top companies, technologies and products in the global health and medical ...
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Biorez Announces FDA 510(k) Clearance of Its Proprietary BioBrace Implant Technology
Biorez Inc., a New Haven start-up advancing tendon and ligament healing, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for two sizes of its BioBrace Implant. This new biocomposite soft tissue scaffold is intended to be used in a broad range of surgical procedures to reinforce soft tissue where weakness exists, and can be used with ...
By Biorez Inc.
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InspireMD Enrolls and Treats First Patients at Ballad Health System in U.S. Registration C-Guardian Clinical Trial of CGuard EPS
InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announces the initiation of enrollment and successful completion of the first cases of the Company’s U.S. registration C-Guardian trial of CGuard EPS. The first patients, who were under the care of ...
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Large Complex Polyps Removed Successfully From Three Patients Without Surgical Intervention Using Lumendi Dilumen C2
A large complex sigmoid polyp in a 62-year-old male patient was successfully removed in a 60-minute procedure without surgical intervention using DiLumen C2, a second-generation endoscopic dual balloon colon stabilization accessory that employs two 6mm working channels that accommodate several flexible therapeutic instruments designed to efficiently retract and dissect tissue. The endolumenal ...
By Lumendi Ltd.
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Pioneering Endosurgery New Mission Statement At Lumendi
Connecticut-based medical device innovator Lumendi, LLC has announced a change in the company’s Mission & Vision statements to better communicate the intended path of its innovative DiLumenTM Endolumenal Interventional Platform (EIP) to transform the GI landscape from surgical intervention to endolumenal. The new statement, Pioneering Endosurgery, will also be used as its tagline in ...
By Lumendi Ltd.
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Medical Device Company Procyrion, Inc. Hires Three to Support Growth; Continues to Build
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, announced today it has hired three additional team members to support the advancement of its intra-aortic heart pump, AortixTM, for use in NYHA Class III-IV heart failure patients. Patricia DaSilva, Margo Fendrich, and Aaron Stone will focus on product development and ...
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SafeHeal Completes First-in-Human Clinical Study of Endoluminal Bypass Sheath
Jan 11, 2019 –SafeHeal, an innovator in the field of digestive surgery, has concluded its first-in-human clinical study for its novel Colovac bypass sheath in patients undergoing colorectal surgery. The single-arm 15-patient study was aimed at evaluating the safety and efficacy of Colovac in the protection of colorectal anastomosis in adult patients who were scheduled to ...
By SafeHeal
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BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices
BioStable Science & Engineering, Inc., a medical technology company focused on products for aortic valve repair for the treatment of aortic insufficiency, today announced that over 500 patients worldwide have now been treated using the HAART Aortic Annuloplasty Device. “Many cardiothoracic surgeons recognize that the young aortic insufficiency patient population cannot be treated with ...
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