Photocure ASA, announced that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer. This is the only combination of drug and device approved for the detection of bladder …

Second Sight Medical Products announced market entry into Singapore, with the first patient implanted with the Company’s Argus® II Retinal Prosthesis System (“Argus II”). The implantation was facilitated by the Company’s exclusive distribution partner in Singapore, Mandarin Opto-Medic Co Pte Ltd. “We are delighted to have completed our first Argus II surgery in Singapore, in collaboration with another leading international …

INtuitive Health announces expansion into the Indianapolis market in partnership with Riverview Health. The newly formed joint venture will build four new retail clinics that offer both 24/7 emergency services and extended hour urgent care under one roof. These facilities will be built in highly convenient retail locations, offering patients easy access to treatment for everything from the common cold …

Venus Concept Ltd. is pleased to announce that it has completed its acquisition of NeoGraft Solutions’ hair restoration business (NeoGraft). Glenn Normoyle, President of NeoGraft, also commented on the acquisition: “We are very happy to join the Venus Concept family. Having spent time with the Venus Concept team, there is consistency in culture and vision between the two companies and …

Spineology Inc. is excited to announce that enrollment is now complete in the Company’s SCOUT clinical trial. The SCOUT (Spineology Clinical Outcomes Trial) IDE, conducted under an FDA-approved protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD). Spineology’s deployable …

LivaNova PLC announced it has entered into an agreement to acquire TandemLife, a privately held company focused on advanced cardiopulmonary temporary support solutions (“TandemLife”). The Pittsburgh-based company offers four product systems, all built around a common pump and controller. These systems, which include ExtraCorporeal Life Support (“ECLS”) and Percutaneous Mechanical Circulatory Support (“pMCS”), are complementary to LivaNova’s strong offerings in …

Centric Medical announced the release of the ROGUE+ Hammertoe Correction System. This sterile-packed innovative system adds to the original implant design also available, while providing internal fixation via a dual threaded construct which is inserted between the proximal and middle phalanges so that the opposing threads fixate within the phalangeal canals of the toe to compress the proximal interphalangeal (PIP) …

After extensive review and evaluation, the U.S. Food and Drug Administration (FDA) recently cleared Multi Radiance Medical’s MR4 Laser technology for neck and shoulder pain relief under the Product Classification NHN, making Multi Radiance one of the few laser manufacturers in the world to secure the NHN product class FDA 510(k) clearance. While many therapeutic laser companies sell products in …

MedShape announced that the first surgeries using the DynaNail® XL TTC Fusion System were successfully performed. The DynaNail XL represents the longer counterpart to the already commercially available DynaNail, the only internal fixation system that uses patented superelastic nickel titanium (NiTiNOL) technology to maintain post-operative active compression like an external fixator and offer immediate dynamization. These surgeries also coincide with …