Posts by cstephenson@legacymedsearch.com
Exact Sciences Signs Partnership with Pfizer to Market Cologuard Tests
Sales representatives of Pfizer Inc., the world’s largest pharmaceutical company, will join Exact Sciences Corp.’s sales representatives in selling the company’s non-invasive screening test for colorectal cancer to physicians and health systems under an agreement announced Wednesday. Pfizer will make at least 625,000 sales calls a year for Exact Sciences under the agreement. The two…
Read MoreFDA Clears UVision360 Office Hysteroscopy Device
Luminelle DTx Hysteroscopy System has received its 510(k) clearance from the FDA with a dual-indication for both hysteroscopy and cystoscopy. The Luminelle DTx Hysteroscopy System is small, easy to use, cost effective and has the potential for an affordable, accurate patient diagnosis and/or therapeutic procedure in one doctor’s office visit. The system went from concept…
Read MoreAvista to acquire Organogenesis
Avista Healthcare Public Acquisition Corp., a publicly traded special purpose acquisition company, and Organogenesis Inc., a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care, Surgical and Sports Medicine markets, today announced that they have entered into a definitive merger agreement, under which Organogenesis will…
Read MoreFDA Clears Brainsway TMS System to Treat OCD
On Friday, the FDA said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder. The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to reduce the severity of OCD in patients. A 100-patient randomized, multi-center study of the device…
Read MoreMolecuLight’s First-of-its-kind Handheld Wound Imaging Device Receives FDA De Novo Clearance
MolecuLight Inc. achieved a major regulatory milestone permitting expansion into the United States market. FDA has granted De Novo clearance for the ground-breaking wound fluorescence imaging device, the MolecuLight i:X. The device digitally captures and documents fluorescence information from wounds and surrounding tissue using still images and videos in real-time. This product is optimized for use at the point-of-care. It…
Read MoreBioSig’s High-Fidelity Electrophysiology System Approved by FDA
BioSig Technologies, Inc. announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA). The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients…
Read More7D Surgical’s Cranial Machine-Vision Guided Surgical System FDA Approved
7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module. This achievement is a crucial step in the commercial launch of 7D Surgical’s innovative Machine-vision Image Guided Surgery (MvIGS) system for cranial surgery throughout the United States. The 7D Surgical System utilizes completely…
Read MoreSiemens & Nuvasive Partner on Spinal Surgery Workflow Development
NuVasive said last week it had inked a strategic partnership deal with Siemens Healthineers looking to develop and advance technology designed for minimally invasive spinal surgery. Through the deal, dubbed the Spine Precision Partnership, the companies will look to jointly advance their proprietary technologies, looking to improve operating room workflow efficiency and the delivery of minimally disruptive spinal…
Read MoreBoston Scientific Spends $160M on Veniti’s Venous Stents
Boston Scientific is proving itself to have more stamina than the Energizer Bunny when it comes to making acquisitions. The Marlborough, MA-based company is now picking up Veniti, a firm that has developed a stent system for treating venous obstructive disease. The deal consists of $108 million up-front cash as well as up to $52 million in…
Read MoreWorld’s Smallest Clot Retriever for Strokes Receives CE Mark
Rapid Medical, based in Yokneam, Israel, won European regulatory approval to introduce its TIGERTRIEVER 13, the narrowest clot retriever now available for use in treating ischemic stroke. The device can be used in vessels as small as 1 millimeter in width and up to a maximum of 2.5 mm, where larger retrievers would be appropriate. It works…
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