Novocure announced that the US Food and Drug Administration (FDA) has approved the NovoTAL (Transducer Array Layout) system through a premarket approval (PMA) supplement. The NovoTAL System allows certified physicians to use the ...
Tags: Novotal System
FzioMed, a medical device company, has received approval from the commissioner of the US Food and Drug Administration (FDA) of its petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel. Oxiplex is ...
Tags: FzioMed, Oxiplex Gel
Cardiovascular Systems, a US-based medical device company, has obtained a premarket approval from the US Food and Drug Administration (FDA) for its Diamondback 360 coronary orbital atherectomy system (OAS), designed to treat severely ...
CardioFocus, developer of the HeartLight endoscopic ablation system (EAS) for the treatment of atrial fibrillation (AF), has concluded enrollment of its US pivotal trial evaluating the HeartLight system, for the treatment of symptomatic ...
Neuros Medical, a US-based neurostimulation company, has obtained an investigational device exemption (IDE) clearance from the US Food and Drug Administration (FDA) to initiate a randomized, controlled pivotal clinical trial to evaluate the ...
Tags: Neuros Medical, Altius System
Sequenom, a US-based manufacturer of DNA massarrays, has announced the submission of premarket 510(k) notifications to the US Food and Drug Administration (FDA) for its IMPACT Dx system and the IMPACT Dx Factor V Leiden and Factor II ...
Tags: Impact DX System, Sequenom
Ventana Medical Systems,a member of the Roche Group, and pharmaceutical company Boehringer Ingelheim (BI) have entered into a collaboration agreement for the development of companion diagnostic tests for BI oncology programs. Companion ...
Exhibitors at the fall High Point Market's preview event continued to praise its viability on Monday, opening day of the two-day Premarket.By giving suppliers early access to buyers representing about half the retail floors its product gets ...
Tags: Furniture, Furnishing
With Furniture Brands International's bankruptcy filing finally behind it and court pending financing lined up, retailers attending Premarket here were largely optimistic the news will lead to better times for Thomasville, Broyhill and ...
Tags: Furniture, Furnishing
Case goods specialist Vaughan Furniture is moving to a new High Point Market showroom at 206 E. Green Drive. The company has occupied about 28,000 square feet in Plaza Suites for the past five years. The new space, previously occupied by ...
Tags: Furniture, Furnishing
Abbott has completed its acquisition of Idev Technologies, a privately held firm that manufactures next-generation medical devices for use by interventional radiologists, vascular surgeons and cardiologists, for $310m. Abbott believes ...
Tags: Abbott, Idev Technologies
PFM Medical, a developer and manufacturer of minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received the US Food and Drug Administration (FDA) premarket approval for its ...
Tags: PFM Medical, Medicine
Leather upholstery resource Simon Li is moving to a larger showroom in the Plaza Suites building for next month's Premarket here. The new 26,000-square-foot space in PS-210 is adjacent to the company's former 15,000-square-foot showroom. ...
Tags: Leather Furniture, Furniture, Furnishing
US- based St. Jude Medical has acquired Endosense, a Switzerland-based company for a purchase price of $170m (CHF159m) up-front plus the potential for up to $161m (CHF150m) in subsequent milestone payments. While the acquisition is ...
The US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel is scheduled to decide on Ocular Therapeutix’s premarket approval application for the ReSure Sealant in September and may suggest some recommendations. ...
Tags: Ophthalmic Devices, Health