Posts by cstephenson@legacymedsearch.com
Prostate Cancer Protection Company BioProtect Raises $25M
BioProtect ltd., a private company with a unique bioabsorbable polymer spacer balloon platform, announced the final closing of $25 million of its Series D equity financing from an unnamed strategic investor and Peregrine Ventures. Every year, more than 1.1 million men are diagnosed with prostate cancer worldwide and approximately 400,000 will undergo prostate radiotherapy. Historically prostate radiation…
Read MoreSpineology Gets FDA De Novo Grant of Minimally Invasive OptiMesh Expandable Interbody Fusion System
Spineology Inc., an innovator in anatomy-conserving surgery, is excited to announce the FDA grant of its proprietary Spineology Interbody Fusion System, now called the OptiMesh Expandable Interbody Fusion System. The grant follows the successful completion of the SCOUT (Spineology Clinical Outcomes Trial) Investigational Device Exemption (IDE) trial. OptiMesh is a unique mesh device that expands…
Read MoreCerapedics Announces Canadian Approval of its Next-generation Bone Graft
Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. “We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ Matrix,” said…
Read MoreIntersect ENT Announces Agreement to Acquire Fiagon for $71M
Intersect ENT, Inc., a company transforming care for patients with ear, nose and throat (“ENT”) conditions, today announced it has entered into an agreement to acquire Fiagon AG Medical Technologies, a leader in electromagnetic surgical navigation solutions, for €60 million in cash. Under the terms of the transaction, Intersect ENT will make an initial €15 million payment at…
Read MoreFitbit Wins FDA 510(k) Clearance and CE Mark for ECG App
Fitbit has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE)marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally. The Fitbit ECG App, unveiled in Fitbit’s recent fall product launch, will…
Read MoreAvinger Receives FDA Clearance of Ocelaris Next Generation Image-guided CTO Crossing System
Avinger, Inc., a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Ocelaris next generation image-guided chronic total occlusion (CTO) crossing system.…
Read MoreMinnetronix Medical Wins FDA Clearance for Innovative Neurosurgical Access Platform
Minnetronix Medical, the company known for 25 years of developing and manufacturing products for medical device companies throughout the world, today announced that it has received FDA clearance for its first platform product: the MindsEye™ Expandable Port for neurosurgical procedures. This clearance represents an expansion of the company’s traditional offerings to include market-ready platforms. The…
Read MoreMedtronic Tricuspid Valve Replacement Device Wins FDA Breakthrough Status
Medtronic, a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back…
Read MoreFujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for Point-of-Care Ultrasound Portfolio
FUJIFILM Sonosite, Inc., specialists in developing cutting-edge point-of-care ultrasound (POCUS) solutions, and part of the larger Fujifilm Healthcare portfolio, today announced that the company has received 510(k) Clearance from the U.S. Food & Drug Administration (FDA) for the company’s entire POCUS portfolio to support healthcare providers in performing accurate lung and cardiac imaging in COVID-19 patients. Fujifilm…
Read MoreCryoLife Acquires Ascyrus Medical
CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has acquired Ascyrus Medical LLC. Ascyrus is a Florida-based, privately-held developer of the Ascyrus Medical Dissection Stent, the world’s first aortic arch remodeling device used for the treatment of acute Type A aortic dissections. The addition of the…
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