commercial-stage medical device News
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PAVmed to Hold a Business Update Conference Call on May 12, 2022
PAVmed Inc. (Nasdaq: PAVM, PAVMZ), a highly differentiated, multi-product, commercial-stage medical device company today announced that the Company will host a business update conference call on Thursday, May 12, 2022, at 4:30 PM EDT. During the call, Lishan Aklog, M.D., Chairman and Chief Executive Officer, will provide a business update including an overview of the Company’s near-term ...
By PAVmed Inc.
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Beyond Air Schedules Third Fiscal Quarter 2023 Financial Results Conference Call and Webcast
Beyond Air, Inc. (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today ...
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Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective ...
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Cerus Endovascular Receives CE Mark Approval for its 021 Contour Neurovascular System
Cerus Endovascular Ltd., a privately held, commercial stage medical device company, today announced that it has received CE Mark approval for its 021 Contour Neurovascular System, compatible with smaller commercially available 021 microcatheters for the treatment of saccular intracranial aneurysms. The Contour Neurovascular System is a unique, fine mesh braid that is deployed across the neck of ...
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Cerus Endovascular and Balt Enter Strategic Distribution Agreement for Innovative Neurovascular Devices to Treat a Range of Intracranial Aneurysms
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company and AB Medica Deutschland Verwaltungs GmbH, a wholly owned subsidiary of Balt, today announced that they have entered into a strategic distribution agreement providing AB Medica with the exclusive rights to market and sell the newly CE marked Contour Neurovascular System™ and the Neqstent Coil Assisted Flow ...
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Profound Medical to Participate in A.G.P.’s Virtual MedTech Summer Conference
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, announced today that management will participate in A.G.P.’s Virtual MedTech Summer Conference on Thursday, July 29, 2021. The event will consist of ...
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Alafair Biosciences Receives 510(k) Clearance for VersaWrap Nerve Protector
Alafair Biosciences, Inc., a commercial-stage medical device company, announced that it has received 510(k) clearance from the FDA for VersaWrap Nerve Protector (VersaWrap). Similar to VersaWrap Tendon Protector indicated for tendon, VersaWrap Nerve Protector is an ultrathin, sutureless, bioresorbable hydrogel implant ideally suited for covering and protecting peripheral nerves. By forming a ...
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Profound Medical to Participate in March Investor Conferences
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that management will participate in two investor conferences in March. 42nd Annual Cowen Health Care Conference: Profound is scheduled ...
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Profound Medical to Participate in the BTIG Virtual MedTech, Digital Health, Life Science and Diagnostic Tools Conference
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, announced today that management will participate in a fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science and Diagnostic Tools Conference on Thursday, February 18, ...
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Profound Medical to Participate in the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Virtual Conference
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that management will participate in the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference, to be held virtually ...
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Cerus Endovascular Receives CE Mark Approval for its Contour 021 device
Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has received CE Mark approval for its state of the art CerusEndo MC 021 microcatheter, designed to allow physicians to access tortuous neurovasculature and deliver therapeutic devices to intended targets. “We remain committed to meeting the ever-increasing needs of the interventional ...
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Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System
Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a U.S. trial for the Contour Neurovascular System™, indicated for the treatment of intracranial aneurysms. The IDE approval follows the receipt of Breakthrough ...
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Cerus Endovascular Announces the First Ever Robotic Assist Intracranial Implant of its Contour Intrasaccular Device
Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced the first ever robotically assisted intracranial implant of its Contour intrasaccular device. The groundbreaking procedure was completed at the King Edward Memorial Hospital, Mumbai, by renowned neurosurgeon, Dr. Nitin Dange and was performed on a Middle Cerebral Aneurysm with a 7mm Contour device. ...
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Cerus Endovascular Receives CE Mark Approvals for its Neqstent Coil Assisted Flow Diverter Designed to Treat Intracranial Aneurysms
Cerus Endovascular Ltd., a privatelyheld, commercial stage medical device company, today announced that it has received CE Mark approval for its Neqstent Coil Assisted Flow Diverter device, designed to treat intracranial aneurysms. Neqstent is designed to treat a range of aneurysm morphologies including wide-necked bifurcation and bifurcation aneurysms. Neqstent is an adjunctive intrasaccular ...
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Cerus Endovascular Successfully Completes Series B Financing and Receives U.S. FDA Approval for its First Microcatheter
Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has now successfully completed its Series B financing having raised a total of $19.0 million from current and new institutional investors since commencement of the round in July 2018. The company also reported that it has received approval from the U.S. Food and Drug Administration (FDA) ...
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IlluminOss Medical Receives Clearance to Expand Clinical Indications in the U.S.
IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that the IlluminOss Photodynamic Bone Stabilization System has received additional clinical clearance and is now indicated by the U.S. Food and Drug Administration (FDA) for use in skeletally mature patients in the treatment of traumatic, ...
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Profound Medical’s TULSA-PRO® Now Compatible with GE Healthcare’s 3T MRI Scanners
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today confirmed the TULSA-PRO® system’s new compatibility with GE Healthcare’s 3T Magnetic Resonance Imaging (“MRI”) scanners. ...
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Preliminary Data Presented from First U.S. Clinical Trial of IlluminOss Medical`s Photodynamic Bone Stabilization System
IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that Richard Terek, M.D., presented the first preliminary data from its U.S. pivotal clinical trial at the recent Musculoskeletal Tumor Society (MSTS) Meeting in Detroit. The IlluminOss System is the world’s only system of its kind which ...
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IlluminOss Medical Receives FDA Clearance for Use in Fibula Fractures
IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System for treatment of fractures of the fibula. The IlluminOss System is a minimally invasive approach for fracture repair and stabilization through a ...
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Merck Announces Acquisition of Alydia Health on behalf of its Planned Spinoff of Organon
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Alydia Health announced today that they have entered into a definitive agreement pursuant to which, after the intended Merck spinoff of Organon, Organon will acquire Alydia Health. Alydia Health is a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum ...
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