Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Intellis spinal cord stimulation and peripheral nerve stimulation systems designed to treat chronic pain. The Fridley, Minn.-based company touted the Intellis as the world’s smallest fully implantable SCS neurostim. The newly-cleared system includes improved battery performance and is managed through the use […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Medacta wins FDA nod for 3DMetal knee revision implants
Medacta said today it won FDA clearance for its 3DMetal tibial cones designed for knee revision surgery. The first procedures with the device were recently performed by Dr. Kevin Hardt and device designer Dr. David Manning of Chicago’s Northwestern University Feinberg School of Medicine and Dr. Dragan Jeremic of Brakel, Germany’s St. Vincenz Krankenhaus, the Switzerland-based […]
7 medtech stories we missed this week: Nov. 3, 2017
From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Hologic launches new MyoSure device Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed […]
Intersect ENT beats Q3 sales estimates, raises full-year forecast
Shares in Intersect ENT (NSDQ:XENT) rose slightly today after the steroid-eluting implant maker beat sales expectations on Wall Street with its third quarter results. The Menlo Park, Calif.-based company posted a net loss of -$4.3 million on sales of $22.3 million for the 3 months ended Sept. 30, for sales growth of 21% compared with the same period last […]
Report: Seven deaths from EpiPen failures this year
Defective EpiPens have been cited in seven deaths this year so far, according to reports made to the FDA and obtained by Bloomberg News. During the same period, the FDA has received 228 reports of EpiPen failures and at least 35 people were hospitalized as a result of those failures. Get the full story at our […]
Second Sight wins full FDA clearance for Orion cortical prosthesis feasibility trial
Second Sight Medical (NSDQ:EYES) said today it won FDA approval to launch a feasibility clinical study of its Orion cortical visual prosthesis system. With the approval, the Sylmar, Calif.-based company is cleared to enroll up to 5 patients total at the University of California at Los Angeles and Houston’s Baylor College of Medicine. The company said […]
Advisory committee backs Indivior’s once-monthly opioid use disorder treatment
Indivior (LON:INDV) said today that the FDA’s psychopharmacologic drugs advisory committee and drug safety and risk management advisory committee voted 18-1 recommending approval of the company’s once-monthly injectable treatment for opioid use disorder. The company’s RBP-6000 treatment is designed for adults with moderate-to-severe opioid use disorder. The FDA is slated to make a decision about Indivior’s […]
Judge approves FDA order barring select Philips AED production until corrections implemented
The FDA today said a US District Judge signed an order prohibiting Royal Philips (NYSE:PHG) and its emergency care and resuscitation biz from producing and distributing AEDs made at its Andover, Mass. and Bothell, Wash.-based facilities until they return to compliance with FDA regulations. In a press release, the agency said that US District Judge Denise […]
Long-term data for Abbott’s Absorb “highlight the need for continued improvements” in BRS tech
Hours before Abbott (NYSE:ABT) presented three-year data from a pivotal trial of its Absorb bioresorbable scaffold, the FDA updated a letter to healthcare providers, writing that the device continues to show an increased rate of major adverse cardiac events and thrombosis compared to patients treated with a drug-eluting stent. “The FDA’s recommendations for health care providers outlined […]
BRH Medical wins FDA nod for electro and ultrasound wound treatment system
Medical device developer BRH Medical said today it won FDA 510(k) clearance for its BRH-A2 device designed to reduce pain and improve deep wound healing through the use of ultrasound and electric fields. The Israel-based company’s BRH-A2 device is designed to engage and stimulate the wound from below the wound bed using both an ultrasound […]
FDA clears Abbott’s Alinity diagnostic analyzers
Abbott (NYSE:ABT) said today it won FDA 510(k) clearance for its Alinity instruments for clinical chemistry and immunoassay diagnostics. The newly launched ci-series of Alinity devices includes improvements such as smaller footprints, improved workflow capabilities and reduced wait times and simplified designs for error proofing and enhanced usability, the company said. “Healthcare systems across the United States are under […]