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Commercial Stage Medical Device Articles & Analysis

35 news found

Beyond Air Schedules Third Fiscal Quarter 2023 Financial Results Conference Call and Webcast

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 ...

ByBeyond Air Inc


Sequana Medical announces results of Annual and Extraordinary General Meetings of Shareholders

Sequana Medical announces results of Annual and Extraordinary General Meetings of Shareholders

Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that all proposed resolutions submitted to the Annual and Extraordinary General Meeting of Shareholders were approved ...

BySequana Medical NV


PAVmed to Hold a Business Update Conference Call on May 12, 2022

PAVmed to Hold a Business Update Conference Call on May 12, 2022

(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. ...

ByPAVmed Inc.


Sequana Medical announces the completion of alfapump implantations in POSEIDON, the North American pivotal alfapump study

Sequana Medical announces the completion of alfapump implantations in POSEIDON, the North American pivotal alfapump study

For more information about the study, please visit clinicaltrials.gov (NCT03973866). About Sequana Medical Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for ...

BySequana Medical NV


Profound Medical to Participate in March Investor Conferences

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 ...

ByProfound Medical Corp.


Profound Medical’s TULSA-PRO® Now Compatible with GE Healthcare’s 3T MRI Scanners

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 ...

ByProfound Medical Corp.


Profound Medical Announces First Patients Treated in Prospective, Randomized Clinical Trial Comparing the TULSA Procedure to Radical Prostatectomy

Profound Medical Announces First Patients Treated in Prospective, Randomized Clinical Trial Comparing the TULSA Procedure to Radical Prostatectomy

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 the first patients have been treated in the Level ...

ByProfound Medical Corp.


Carlsmed and the International Spine Study Group Foundation Announce Long-term Partnership

Carlsmed and the International Spine Study Group Foundation Announce Long-term Partnership

--(BUSINESS WIRE)--Carlsmed, Inc., a commercial stage medical device technology company, is announcing today that it has partnered with the International Spine Study Group Foundation (ISSGF), the premier study group on adult spinal deformity, to collect data on surgical treatment with personalized interbody ...

ByCarlsmed, Inc.


Profound Medical to Participate in A.G.P.’s Virtual MedTech Summer Conference

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 ...

ByProfound Medical Corp.


Profound Medical and Akumin Enter into U.S. Multi-Center Commercial Agreement for TULSA-PRO

Profound Medical and Akumin Enter into U.S. Multi-Center Commercial Agreement for TULSA-PRO

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 the signing of a multi-site imaging center agreement ...

ByProfound Medical Corp.


Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System

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 ...

ByCerus Endovascular Inc.


Merck Announces Acquisition of Alydia Health on behalf of its Planned Spinoff of Organon

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 ...

ByMerck & Co., Inc.,


Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System

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 ...

ByCerus Endovascular Inc.


Profound Medical Signs Agreement with GE Healthcare to Expand Provider Access to TULSA-PRO

Profound Medical Signs Agreement with GE Healthcare to Expand Provider Access to TULSA-PRO

We are grateful to our existing customers who have embraced TULSA-PRO® and look forward to making the benefits of this technology even more widely available.” About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets customizable, incision-free ...

ByProfound Medical Corp.


Cerus Endovascular Announces the First Ever Robotic Assist Intracranial Implant of its Contour Intrasaccular Device

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. ...

ByCerus Endovascular Inc.


Profound Medical Receives FDA HDE Approval for Sonalleve

Profound Medical Receives FDA HDE Approval for Sonalleve

Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) announced today that Sonalleve® has received U.S. ...

ByProfound Medical Corp.


IlluminOss Medical Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware

IlluminOss Medical Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware

IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced an expanded U.S. ...

ByIlluminOss Medical, Inc.


Alafair Biosciences Receives 510(k) Clearance for VersaWrap Nerve Protector

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). ...

ByAlafair Biosciences, Inc.


Profound Medical to Present at the Cantor Virtual Global Healthcare Conference

Profound Medical to Present at the Cantor Virtual Global Healthcare Conference

The presentation will be broadcast live and archived on the Company's website at www.profoundmedical.com under "Webcasts" in the Investors section. About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation ...

ByProfound Medical Corp.


IlluminOss Medical Receives FDA Clearance for Use in Fibula Fractures

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. ...

ByIlluminOss Medical, Inc.

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